PPTL.QM.001 Iss 01 - ISO 9001 Quality Manual - Full [Unsigned]

ISO 9001
























Q U A L I T Y















M A N U A L





























PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED
























































THIS IS A CONTROLLED COPY AND SHOULD NOT BE DUPLICATED WITHOUT AUTHORITY

FROM THE MANAGEMENT OF PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED

Prepared by: Manager – Quality Assurance & QPPV










Signature: Date:











Approved by: Director











Signature: Date:

QUALITY MANUAL





PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED



DOCUMENT NUMBER ISSUE NUMBER SUPERSEDES EFFECTIVE DATE

PPTL/QM/001 02 01 14.12.2018




SECTION CONTENT PAGE NUMBER
1.0 Terms & Definitions 3

2.0 Introduction 4

3.0 Reference Documents 5
4.0 Context of the Organization 6

4.1 Understanding the Organization and its Context 6

4.2 The Needs and Expectation of Interested Parties 6
4.3 Scope of the Quality Management System 6

4.4 Quality Management System and its Processes 6 – 7

5.0 Leadership 8

5.1.2 Customer Focus 8 – 9
5.2 Policy 9

5.3 Organizational Roles, Responsibilities and Authorities 9 – 10

6.0 Planning 11

6.1 Action to Address Risks and Opportunities 11
6.2 Quality Objectives 11

6.3 Planning for change 12

7.0 Support 13
7.1 Resources 13

7.1.2 People 13

7.1.3 Infrastructure 13
7.1.4 Environment for the Operation of the Processes 14

7.1.5 Monitoring and Measuring resources 14

7.1.6 Organizational knowledge 14 – 15

7.2 Competence 15
7.3 Awareness 15

7.4 Communication 15

7.5 Documented Information 15 – 17

8.0 Operations 18
8.1 Operational Planning and Control 18

8.2 Requirements for Products and Services 18 – 19

8.3 Design and Development - Justification for Non-Applicability 19
8.4 Control of Externally Provided Processes, Products and Services 19 – 20

8.5.1 Control of Production and Service Provision 20 – 21

8.5.2 Identification and Traceability 21

8.5.3 Property belonging to Customers or External Providers 21
8.5.4 Preservation 21

8.5.5 Post – Delivery Activities 22

8.5.6 Control of Changes 22

8.6 Release of Products and Services 22
8.7 Control of Non - Conformities 22 – 23

9.0 Performance Evaluation 24

9.1 Monitoring, Measurement, Analysis and Evaluation 24
9.1.2 Customer Satisfaction 24

9.1.3 Analysis and Evaluation 24 – 25

9.2 Internal Audits 25
9.3 Management Review 25 – 26

10.0 Improvement 27

11.0 Amendment Log 28

Appendices





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1.0 TERMS AND DEFINITIONS

For the purposes of this quality manual, the terms and definitions found in the current edition of ISO 9000

International Standard shall apply.



Customer Firm or person having a contractual agreement with, or the recipient of a

product from Phillips Pharmaceuticals (Tanzania) Limited.

Internal Audit Systematic independent and documented process for obtaining audit evidence and

evaluating it objectively to examine the extent to which audit criteria are fulfilled.

Organization Phillips Pharmaceuticals (Tanzania) Limited.

Procedure Specified way to carry out an activity or a process.

Product Result of a process which is the result of a number of four generic product

categories including hardware, software, processed materials and services.

Supplier Party to whom an order has been placed by the organization for the purchase of

supplies, or the execution of a specific part of a particular order.

Quality Management System Management System to direct and control an organization with regard to its

quality.



In addition, the following terms/Acronym are also referenced:



ERP Enterprise Resource Planning
EU European Union

GDP Good Distribution Practice

GFD Group Financial Director

GMD Director

HR Human Resource

PPTL Phillips Pharmaceuticals (Tanzania) Limited

QA Quality Assurance

QM Quality Manual

QMR Quality Management Representative

QMS Quality Management System

SOP Standard Operating Procedure

TFDA Tanzania Food and Drug Authority

USAID United States Agency for International Development

WHO World Health Organization









































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2.0 INTRODUCTION

2.1 GENERAL

Phillips Pharmaceuticals (Tanzania) Limited operates from Vingunguti Industrial Area along Old Nyerere Road,

Dar es Salaam, Tanzania and exists to establish a safe, secure, reliable and sustainable health supply chain that

ensures access to affordable quality healthcare services.



With a view to meeting our customers’ needs and expectations and thus achieve our vision, a quality

management system (QMS) has been established and is implemented for continual improvement in order to:

• Demonstrate the ability of Phillips Pharmaceuticals (Tanzania) Limited to consistently provide services

that meet customer and applicable statutory and regulatory requirements

• Aiming to enhance customer satisfaction through the effective application of the system, including

processes for improvement of the system and the assurance of conformity to customer and applicable

statutory and regulatory requirements.



2.2 PROFILE

Phillips Pharmaceuticals (Tanzania) Limited, a fully owned subsidiary of Phillips Pharmaceuticals Group in Kenya was

incorporated in 2004 to offer focused and specialized services to various projects that sought to make a contribution

towards meeting the healthcare needs of the population at the base of the pyramid. In the ensuing years, PPTL has
continued to partner with various organizations and spear-head the development of innovative approaches to


meeting various healthcare needs to the target population.


PPTL continually seeks to provide excellence in the provision of the following services:


• Procurement.

• Warehousing.

• Order Management and Customer Service.

• Distribution.



2.3 CORPORATE GOALS
2.3.1 GENERAL

In order to have common goals and hence direct the company’s efforts towards achievement of its goals, the

management has come up with corporate goals as outlined below.



2.3.2 PPTL’S VISION STATEMENT

Please see Mission, Vision and Core Values for the Organization (Appendix I – PPTL/QMS/QA/029)



2.3.3 PPTL’S MISSION

Please see Mission, Vision and Core Values for the Organization (Appendix I – PPTL/QMS/QA/029)



2.3.4 PPTL’S VALUES

The guiding values applied by the management of PPTL to accomplish this mission are as shown in Appendix I

– PPTL/QMS/QA/029.


















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3.0 REFERENCE DOCUMENTS

The contents of the documents mentioned below are considered part of the current document and are

applicable to its subject matter where quoted.



ISO 9000 Quality Management Systems - Fundamentals and Vocabulary

ISO 9001 Quality Management Systems - Requirements

ISO 19011 Guidelines for Quality and/or Environmental Management Systems Auditing.



NB: For the purpose of this Quality Manual, the current editions of ISO standards including ISO 9000, ISO 9001,

ISO 19011 apply. Thus, where the edition is omitted e.g. ISO 9001:2015, then it implies that the current standard

applies.











































































































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4.0 CONTEXT OF THE ORGANISATION


4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT
PPTL has determined the External (see Appendix II – PPTL/QMS/QA/019) and the Internal Issues (see Appendix

III – PPTL/QMS/QA/020) that are relevant to its purpose and its strategic direction and that can affect its ability

to achieve desired results of its Quality Management System. Such internal and external issues are subject to

change and thus require monitoring and review. The review is done annually during Management Review as

stated in the SOP Number PPTL/SOP/QA/009; Point 5.3.8. Monitoring is a constant process with information

about external and internal issues available from many sources, such as through internal documented

information and meetings, in the national and international press, websites, publications from national

statistics offices and other government departments, professional and technical publications, conferences and

meetings with relevant agencies, meetings with customers and relevant interested parties, and professional

associations.



4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES

Due to their effect or potential effect on the organization ability to consistently provide products and services that

meet customer and applicable statutory and regulatory requirements, PPTL has determined the interested parties that

are relevant to the QMS and their requirements (see Appendix IV – PPTL/QMS/QA/021).



4.3 DETERMINE THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM

The scope of the PPTL QMS will cover the Entire Organization located at Plot 111, Vingunguti Industrial Area, Dar-es-
Salaam, Tanzania.



PPTL shall apply the requirements of these International Standard but Clause 8.3 on Design and Development of

Products and Services will not be applicable within the above determined scope of its Quality Management

System. This is because PPTL does not do any design or development. The fact that this particular clause is not

applicable does not affect the PPTL’s ability, or responsibility to ensure conformity of its products and services

and enhancement of customer satisfaction. We confirm the quality of the products we receive through our

internal quality control activities as stated in the SOP Number – PPTL/SOP/DH/002 – Receipt of Goods.



4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES

PPTL has established, documented, implemented a QMS which we maintain and continually strive to improve

its effectiveness in accordance with the requirements of the current ISO 9001.



4.4.1 PPTL’S PROCESSES

The company has determined the main business or core processes as well as relevant support processes and

their application throughout the organization. Within each process are other sub processes:

• Determined the sequence and interaction of the processes. (See Appendix V – PPTL/QMS/QA/022)

• PPTL has determined and applied criteria and methods (including monitoring, measurements, and

related performance indicators) needed to ensure effective operation and control of these processes.

• Determined the resources for these processes and ensured their availability.

• PPTL has also assigned the responsibilities and authorities for these processes.

• Addressed the risks and opportunities determined.

• Continually evaluate the processes and implement any changes needed to ensure that these processes
achieve intended results.


• Improve the processes and the Quality Management System. The PPTL’s QMS is comprised of the processes
as listed in the table that follows:





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NO PROCESS FOCUSES ON

Charting the Organization’s Direction and Growth, supporting the

development of an enabling environment, leading and guiding the
1 Top Management
staff, organizing structure and roles and spear-heading process

development in order to achieve company objectives.

Supporting the recruitment and development of staff and the

2 Human Resources maximizing of the partnership between the staff and the organization

thus achieving the organization’s goals.

Ensuring the organization adheres to various statutory requirements,

provision of required equipment and consumables and spear-
heading the management of contracted services and external service
Administration & Information
3 providers and ensuring IT infrastructure of the organization is well
Technology
established, maintained, and improved as per the demands of the

organization and market demands and providing IT solutions where

necessary.

Ensuring appropriate planning, availability and utilization of financial

4 Finance & Accounts resources to support the achievement of the organization’s desired

results.

Facilitating the establishment, implementation, maintenance and

continuous improvement of a QMS in order to consistently satisfy

5 Quality Assurance customers and meet statutory and regulatory requirements as well as

ensuring a robust quality assurance framework is established and

implemented.

Ensuring that commodities procured are received, stored, handled

6 Warehousing and processed safely and efficiently as per the Good Distribution

Practice and Regulatory requirements.

Liaising with the consumers and customers to ensure that their

7 Customer Support commodity needs are met and enquiries handled in line with

contracting entity requirements and regulatory guidelines.

Ensure products are packed, dispatched, transported and delivered as

8 Distribution per customer needs as well as contracting entity requirements and

regulatory guidelines

Ensuring compliance with statutory and regulatory requirements
9 Regulatory Affairs & Compliance
primarily related to product, premises and processes.

Facilitating the establishment of adverse event reporting framework

within the organization and being a focal point of contact for any
10 Pharmacovigilance
adverse related information for the principals and also the regulatory

bodies.

Ensuring that commodities are procured, handled and cleared from

11 Import & Export the port efficiently as per the Good Distribution Practice and

Regulatory requirements.



4.4.2 To the extent necessary PPTL has done the following:
• Maintained Documented Information to support the Operation of its Processes.

• Retained Documented Information to have confidence that the processes are being carried out as planned.








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5.0 LEADERSHIP

5.1. GENERAL

The Directors and other Top Management demonstrate leadership and commitment with respect to the Quality

Management System by:

• Taking Accountability for the Effectiveness of the Quality Management System.

• Ensuring the Quality Policy and the Quality Objectives are established for the QMS and are compatible

with the context and strategic direction of PPTL.

• Ensuring the integration of QMS requirements into PPTL Business Processes.

• Promoting the use of the Process Approach and Risk Based Thinking.

• Ensuring the resources needed for the QMS are available.

• Communicating the importance of Effective Quality Management and of conforming to the QMS

requirements.

• Ensuring the QMS achieves its intended results.

• Engaging, directing and supporting persons to contribute to the effectiveness of the QMS.

• Promoting improvement.

• Supporting other relevant management roles to demonstrate leadership as it applies to their areas of

responsibility.


To demonstrate evidence of leadership and commitment to the development and improvement of the Quality


Management System, the Director has established a Quality Policy and ensured that Quality Objectives are
established at relevant processes and ensures the availability of necessary resources. The Management Review

Meetings are chaired by the Director.



The Director has assigned the Manager – Quality Assurance and QPPV as the QMR with the delegated authority

and responsibility for the development, overall implementation and maintenance of the Quality Management

System together with the control and issue of all Quality Documentation.



The QMR is responsible for monitoring the QMS and in particular for advising, training other personnel in the

system, continually looking for improvements, ensuring that internal quality audits are carried out as detailed

on a planned schedule, ensuring that all corrective and preventive actions arising from audits are closed out,

reporting to the management review on the performance, including need for improvement and the awareness

of customer needs and requirements throughout Phillips Pharmaceuticals (Tanzania) Limited.




5.1.1 CUSTOMER FOCUS
The Directors and other Top Management demonstrate leadership and commitment to Customer Focus by

ensuring that:

• Customer and applicable statutory and regulatory requirements are determined, understood and

consistently met.

• The risks and opportunities that can affect conformity of products and services and the ability to

enhance Customer Satisfaction are determined and addressed

• The focus on enhancing Customer Satisfaction is maintained.


















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To demonstrate these PPTL has set up a Customer Support Department with several employees and a Director

to oversee. Customer satisfaction surveys are done annually and customer concerns and complaints are

tracked, root cause analysis done and then they are closed. PPTL has also established a risk management

procedure PPTL/SOP/QA/010 to ensure that risks that can affect the conformity of products and services are
determined and addressed.




5.2 POLICY

5.2.1 ESTABLISHING THE QUALITY POLICY

PPTL top management has established a Quality Policy that:

• Is appropriate to the purpose of PPTL, its Context and supports its Strategic Direction.

• Provides a framework for setting Quality Objectives.

• Includes a Commitment to satisfy applicable requirements.

• Includes a Commitment to Continual Improvement of the QMS.


The Policy (see Appendix VI – PPTL/QMS/QA/023) is approved by the Director and is supported at all levels of

management within the Phillips Pharmaceuticals (Tanzania) Limited and will be reviewed regularly for continual

improvement.




5.2.2 COMMUNICATING THE QUALITY POLICY
PPTL Quality Policy:

• Shall be available and maintained as a Documented Information.


• Be communicated, understood and applied within the Organization.
• Be available to relevant interested parties as appropriate.



A Quality Policy which is appropriate to the purpose of Phillips Pharmaceuticals (Tanzania) Limited has been

established and communicated by ensuring that it is placed at key areas including at the Reception as well

being communicated to new staff during their Induction Session of PPTL QMS. It shall also be included within

the corporate profile which is circulated amongst our interested parties before engagement. The Quality Policy

has also been translated into a Kiswahili version for better understanding of the staff (See – Appendix VII).



5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES

The Director has ensured that the responsibilities and authorities for relevant roles are assigned, communicated, and

understood within the organization. They have assigned responsibility and authority for the following:

• Ensuring that the QMS conforms to the requirements of the current international ISO 9001 standard.

• Ensuring that the processes are delivering their intended inputs.

• Reporting on the performance of the QMS and on opportunities for improvement to the top management.

• Ensuring the promotion of customer focus throughout the organization.

• Ensuring that the integrity of the QMS is maintained when changes to the QMS are planned and implemented.



5.3.1 ORGANIZATION STRUCTURE
PPTL is staffed by a blend of experienced personnel including registered pharmacists who are skilled in their

areas of operation. The hierarchical structure of PPTL Company is as shown in Appendix VIII –

PPTL/QMS/QA/024.



PPTL ensures that the responsibilities, authority and the interrelation of all personnel who manage, perform

and verify work affecting quality are defined and communicated in order to facilitate effective quality

management. All key personnel have been given authorities and responsibilities to enable them to assist in the



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achievement of the quality objectives. This assignment of authority and responsibility helps to establish

involvement and commitment of people throughout Phillips Pharmaceuticals (Tanzania) Limited.



The responsibility of personnel is given. An individual may be appointed with a dual role (within the Phillips
Pharma Group Tanzania), in such cases he/she will be responsible for fulfilling the tasks assigned to both roles.


The company issues job descriptions to personnel and maintains a copy in personnel records.


























































































































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6.0 PLANNING

6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES

In the process of planning for its QMS, PPTL has considered the external and internal issues that are relevant to its

purpose and its strategic direction and that can affect its ability to achieve the intended results of its QMS. It has also

considered the needs and expectations of interested parties. These two considerations have been used to determine

the risks and opportunities that need to be addressed to:

• Give assurance that the QMS can achieve its desired results.

• Enhance desirable effects.

• Prevent or reduce undesired effects.

• Achieve improvement.



The organization has planned actions to address these risks and opportunities and how to carry out the following:

• Integrate and implement the actions into its QMS processes.

• Evaluate the effectiveness of these actions.



PPTL has established a Risk Management Procedure PPTL/SOP/QA/010 which details how risks and opportunities will

be addressed. There is also a Business Continuity Plan that details what would need to be done in case of a major

disaster. The actions taken to address risks and opportunities are proportionate to the potential impact on the
conformity of products and services.



6.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM

Phillips Pharmaceuticals (Tanzania) Limited applies suitable methods for monitoring and, where applicable,

measurement of the quality management system processes to demonstrate the ability of the processes to

achieve planned results. When planned results are not achieved, correction and corrective action is taken, as

appropriate, to ensure conformity of the service.



6.2.1 PPTL has established Quality Objectives at relevant processes needed for the quality management system. The

Quality Objectives are as follows:

• Consistent with the Quality Policy.

• Measurable.

• Take into account applicable requirements.

• Relevant to the conformity of products and services and to the enhancement of customer satisfaction.

• Can be monitored.

• Can been communicated.

• Can be updated as appropriate.



6.2.2 In the process of planning how to achieve the Quality Objectives, PPTL has determined:

• What will be done?

• What resources will be required?

• Who will be responsible?

• When it will be completed?

• How the results will be evaluated?


Each process area shall set Quality Objectives in terms Key Performance Indicators that shall be monitored quarterly

and the report sent to the QMR. Every six months a consolidated report shall be prepared and discussed as part of the

agenda for the Management Review Meeting. See the attached Quality Objectives as Appendix IX –

PPTL/QMS/QA/026 – Quality Objectives for PPTL as an Organization.



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6.3 PLANNING OF CHANGES

When PPTL determines the need for changes to the QMS, the changes shall be carried out in a planned manner. The

following consideration shall be made:

• The purpose of the changes and their potential consequences.

• The integrity of the Quality Management System.

• The availability of resources.

• The allocation or reallocation of responsibilities and authorities.


PPTL has established a Change Control Procedure, PPTL/SOP/QA/007 to ensure that all major changes related to the

maintenance of the PPTL QMS and Good Distribution Practice are reviewed, approved and communicated

appropriately before implementation.












































































































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7.0 SUPPORT

7.1 RESOURCES

7.1.1 GENERAL

PPTL has determined and provided the resources needed for the establishment, implementation, maintenance and

continual improvement of the QMS. The organization has considered the capabilities of, constraints on, existing

internal resources and what needs to be obtained from external providers.



The PPTL management provides the resources needed to develop, implement and continually improve the

processes of the Quality Management System and to address and enhance customer satisfaction in a timely

manner to ensure requirements are met.



7.1.2 PEOPLE

The organization has determined and provided the persons necessary for the effective implementation of its QMS and

for the operation and control of its processes (see Appendix VIII – PPTL/QMS/QA/024). PPTL ensures that personnel

performing work affecting the company’s Quality Management System are competent on the basis of

applicable education, training, skills and experience, see SOP Number PPTL/SOP/HR/001 and

PPTL/SOP/HR/006.


PPTL is staffed by a blend of experienced personnel including pharmacists who are skilled in their areas of


operation. The hierarchical structure of PPTL Company is as shown in Appendix VIII – PPTL/QMS/QA/024. PPTL
ensures that the responsibilities, authority and the interrelation of all personnel who manage, perform and

verify work affecting quality are defined and communicated in order to facilitate effective quality management.



All key personnel have been given authorities and responsibilities to enable them to assist in the achievement

of the quality objectives. This assignment of authority and responsibility helps to establish involvement and

commitment of people throughout Phillips Pharmaceuticals (Tanzania) Limited.



The responsibility of personnel is given. An individual may be appointed with a dual role (within the Phillips

Pharma Group Tanzania), in such cases he/she will be responsible for fulfilling the tasks assigned to both roles.

The company issues job descriptions to personnel and maintains a copy in personnel records as stated in SOP

Number PPTL/SOP/HR/003 – Staff Record Maintenance.



7.1.3 INFRASTRUCTURE

PPTL has determined, provided and maintained an infrastructure necessary for the operation of its processes and to

enable it achieve conformity of products and services. These resources include:

• Warehouses for storage of products at ambient temperature, cold rooms, refrigerators, freezer room, freezers

for products that require cold storage.

• Equipment example: hand pallets, trolleys and pallet shifters.

• Transportation resources in terms of vans, trucks and motor bikes.

• An enterprise resource planning system, internet and phone services for information management and

communication.


The Distribution Hub Manager in collaboration by Quality Assurance Manager, with support from the Management

Team determines, provides and arranges maintenance for the infrastructure needed to achieve the conformity of the

service requirements, including buildings, workspace and associated facilities, process equipment such as cold room,

computer hardware and software, communication media, transport and supporting services.





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7.1.4 ENVIRONMENT FOR THE OPERATION OF PROCESSES

PPTL has determined, provided and maintained the environment necessary for the operation of its processes and to

enable it achieve conformity of products and services.

• The temperature and humidity of the warehouses and the storage areas is monitored as stated in the SOP
Number PPTL/SOP/DH/013.


• The environment and equipment are appropriately maintained by ensuring a clean and pest free environment
as stated in the SOP Numbers PPTL/SOP/DH/006, PPTL/SOP/DH/012 and PPTL/SOP/AD/004.


• Ensuring that the equipment are serviced and calibrated and the storage areas are validated or qualified as
stated in the SOP Numbers PPTL/SOP/DH/010 and PPTL/SOP/DH/018.


• There is a designated area for the staff to refresh themselves. The management ensures a calm and non-
discriminatory environment that is suitable for the staff.


• The EHS Committee ensures that the working environment in the company’s offices and warehouse areas is
suitable at all times to achieve conformity to product requirements as stated in the SOP Number

PPTL/SOP/AD/004.

• The company ensures that physical and physiological factors that can affect the products output and

employee’s efficiency are also considered. This shall be handled by the EHS Committee as stated in the

PPTL/SOP/AD/004.

• PPTL provides where necessary Protective Clothing (PPE) such as overcoat, cold room jacket, safety boots

especially to warehouse employees as stated in stated in the SOP Number PPTL/SOP/AD/001.



7.1.5 MONITORING AND MEASURING RESOURCES

7.1.5.1 GENERAL

PPTL has determined and provided the resources needed to ensure valid and reliable results when monitoring or

measuring is used to verify the conformity of products and services to requirements.

PPTL has ensured that the resources provided are suitable for the specific type of monitoring and measurements

undertaken.

• For monitoring of temperature and humidity we have a Remote Monitoring System in place that monitors
continuously and alerts responsible staff of any excursion through an SMS and email alerts.


• All the equipment used for measurements is calibrated annually to ensure their continuing fitness for purpose.


7.1.5.2 MEASUREMENT TRACEABILITY

Measuring Traceability is a requirement and is considered by PPTL as an essential part of providing confidence in the

validity of measurement results. In this regard the measuring equipment used such as data loggers and thermo

hygrometers for monitoring temperature and humidity to ensure conformity to products requirements are:


• Calibrated annually against measurement standards traceable to the national measurements standards
provided by Tanzania Bureau of Standards (TBS).


• Has been identified and a schedule maintained showing calibration/inspection status.
• Safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and

subsequent measurement results.



7.1.6 ORGANIZATIONAL KNOWLEDGE

PPTL has determined the knowledge necessary for the operation of its processes and to achieve conformity of

products and services. The knowledge shall be maintained and made available to the extent necessary. Some of the

way the knowledge will be maintained will be through:

• QMS documentations including Quality Policy, Quality Manual, SOPs for all the processes, and Quality

Objectives and various records and other relevant documents/guidelines that we refer to.

• Hand over notes from the process leads detailing their work, the reports needed and key contacts for their



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process areas.

• Minutes of departmental, business operations and management meetings.

• Results of both internal and external audits.


7.2 COMPETENCE


• PPTL has determined the necessary competence of persons doing the work under its control that affects the
performance and effectiveness of the QMS.

• PPTL has ensured that the persons are competent on the basis of appropriate education, training or

experience. Employees are given job descriptions and made aware of the relevance and importance of

their activities and how they contribute to the achievement of quality objectives are defined. The HR

maintains records of education, experience and training as stated in the SOP Number

PPTL/SOP/HR/003.


• Will retain applicable documented information as evidence of competence.


7.3 AWARENESS

The organization shall ensure that the persons doing the work under the organization control are aware of:

• Quality Policy through creating awareness for the new staff as stated in the SOP Number PPTL/SOP/HR/001 as

well as placing it in strategic places for the staff to see.

• Relevant Quality Objectives. The process leads shall set quality objectives for their area and monitor them

quarterly as well as create awareness of the quality objectives to their staff.

• The process leads will ensure that the persons understand their contribution to the effectiveness of the QMS

including the benefits of improved performance.

• The persons will also be made aware of the implications of not conforming to the QMS requirements.



7.4 COMMUNICATION

PPTL has determined the internal and external communications relevant to the QMS including:

• What to communicate - PPTL will communicate the Quality Policy and Quality Objectives.

• When to communicate - Quality Policy will be communicated to new staff and all the other staff continually,

and to interested parties when required.

• With whom to communicate - Staff and Interested parties.

• How to communicate - Quality Policy will be communicated to new staff through the introduction to the PPTL
QMS as well as mounting it in strategic places.


• Who communicates - The Top Management will communicate Quality Policy while process leads will
communicate quality objectives to the staff.



7.5 DOCUMENTED INFORMATION

7.5.1 GENERAL

PPTL Quality Management System shall include:

• Documented Information required by this standard example: Quality Policy, Quality Objectives, SOPs and

Organizational Structure.

• Documented Information determined by PPTL as being necessary for the effectiveness of the QMS example:

Quality Manual and Mandatory Procedures named Quality Assurance Procedures.













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Quality

Manual





Standard Operating Procedures





Other Documents





Retained documented information




Levels of Documentation of PPTL QMS



LEVEL 1: QUALITY MANUAL

This is a top-level policy document that consists of corporate goals and policies that ensure the smooth

operation of PPTL. It includes the following:

• The company profile.

• External and internal issues that can affect PPTL QMS.

• Needs and expectations of interested parties.

• The scope of the PPTL QMS.

• Interaction of processes.

• References to the procedures and other documents of the QMS.

• Justification for any clause of the ISO 9001 standard that is not applicable.

• Determination and review of requirements to products and services.


LEVEL 2: STANDARD OPERATING PROCEDURES

These documents describe the actual processes, and controls applied, to the activities concerned with the

attainment of quality products/services. Processes have one or more procedures related to them. Procedures

explain what, who and how activities are carried out in the company. They are comprised of the 9 mandatory

procedures, specified in the quality manual and other procedures, all referred to as QA SOPs. These include:


• Documents Control - PPTL/SOP/QA/003.
• Records Control – PPTL/SOP/QA/004.


• Quality Audits – PPTL/SOP/QA/005.
• Handling Deviations - PPTL/SOP/QA/006.

• Change Control – PPTL/SOP/QA/007.

• Trainings – PPTL/SOP/QA/008.

• Management Review – PPTL/SOP/QA/009.

• Risk Management – PPTL/SOP/QA/010.

• Sub-Contractor Management – PPTL/SOP/QA/011.














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LEVEL 3: OTHER DOCUMENTS FOR EFFECTIVE CONTROL OF PROCESSES

All other documents supporting QMS such as standard operating procedures and work instructions, if

necessary, are controlled as per procedure for control of maintained documented information, PPTL/

SOP/QA/003.



LEVEL 4: RETAINED DOCUMENTED INFORMATION
Relevant quality documented information shall be retained in the PPTL reporting systems as evidence of

accomplishment of set objectives. This will be controlled as per procedure for control of retained documented

information, PPTL/SOP/QA/004.



7.5.2 CREATING AND UPDATING

When creating and updating documented information PPTL has ensured:


• Identification and description (title, date and reference number) where applicable.

• Format and Media.
• Review and approval for suitability and adequacy.



7.5.3 CONTROL OF DOCUMENTED INFORMATION

7.5.3.1 Documented information required by PPTL QMS and by ISO 9001 Standard shall be controlled to ensure it is

available and suitable for use, where and when it is needed and is adequately protected from loss of confidentiality,

improper use and loss of integrity as stated in the SOP Number PPTL/SOP/QA/003.



7.5.3.2 For the control of documented information, PPTL has addressed the following:

• Distribution, access, retrieval and use.

• Storage and preservation, including preservation of legibility.

• Control of changes.

• Retention and disposition.


Documented information of external origin determined by the organization to be necessary for the planning and


operation of the QMS shall be identified as appropriate and controlled. Documented information retained as evidence
of conformity shall be protected from unintended alterations. The company controls QMS documentation to

ensure that correct documents are used as stated in detail in SOP Numbers PPTL/SOP/QA/003 and

PPTL/SOP/QA/004. We promptly remove all obsolete/invalid documents from all points of issue, therefore

preventing unintended use. Documents to be retained, and records of quality performance, are controlled,

maintained and protected. The company employs necessary controls to ensure that the latest copies of all

documentation relevant to the accomplishment of work are available at the time and place of work, thus

enabling the effective functioning of organization’s QMS.


































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8.0 Operation

8.1 OPERATIONAL PLANNING AND CONTROL

The organization shall plan, implement and control the processes needed to meet the requirements for the provision

of products and services, and to implement actions by:


• Determining the requirements for the products and services.
• Establishing criteria for the processes and the acceptance of products and services. The criteria shall be set in

terms of Key Performance Indicators within the departments.

• Determining the resources needed to achieve conformity to the products and service requirements.

• Implementing control of the processes in accordance with criteria.

• Determining and maintaining documented information to the extent necessary to have confidence that the

processes have been carried out as planned and to demonstrate the conformity of products and services to

requirements. All of these is by implementing risk-based thinking, internal audit procedures, opportunities for

improvement and management review using the QA SOPs stated above.



The output of this planning shall be suitable for PPTL operations. The organization shall control planned changes and

review the consequence of unintended changes taking action to mitigate any adverse effects as necessary. This shall

be done using the Change Control Procedure as stated in SOP Number PPTL/SOP/QA/007. A procedure on

subcontractor management PPTL/SOP/QA/011 and a procedure for supplier prequalification PPTL/SOP/BD/007 has
been established to ensure all outsourced activities are controlled.



8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES

8.2.1 CUSTOMER COMMUNICATION

Communication with customers shall include the following:


• Providing information relating to products and services.

• Handling enquiries, contract or orders including changes.

• Obtaining customer feedback relating to products and services, including customer complaints.
• Handling or controlling customer property.


• Establishing specific requirements for contingency actions where relevant.


Methods and procedures as covered by the SOP Number PPTL/SOP/CS/003 – Customer Inquiries and Feedback

along with a Price List have been identified and implemented to communicate with customers on information

about the products and services, to deal with enquiries, contracts or order handling, including amendments,

customer feedback and complaints.



8.2.2 DETERMINING THE REQUIREMENTS FOR PRODUCTS AND SERVICES

The requirements including service requirements specified by the customer are determined when receiving

orders as stated in the SOP Number PPTL/SOP/CS/002 – Receipt of Orders. In particular, consideration is given

to:

• The extent to which customers have specified the requirements of the product/service example: expiry
date of products.


• Customer requirements, availability of the product, collection, delivery and support example: delivery
times.


• Requirements not specified by the customer but necessary for fitness and purpose example: monitoring
of the warehouse and transit temperature and humidity.


• Obligations related to product, and service including statutory and legal requirements example:
licensing of the Pharmacists, fire safety, etc.


• Any additional requirements determined by PPTL.


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8.2.3 REVIEW OF THE REQUIREMENTS FOR PRODUCTS AND SERVICES

8.2.3.1 PPTL shall ensure that it has the ability to meet the requirements for products and services offered to

customers. The organization shall conduct a review by cross-confirming the requirements with the customer as stated

in the SOP Number PPTL/SOP/CS/002 before committing to supply products and services to a customer to include
the following:


• Requirements specified by customer.

• Requirements not stated by customer but necessary for the specified or intended use, when known.

• Requirements specified by the organization.

• Statutory and regulatory requirements applicable to the products and services.

• Contract or order requirements differing from those previously expressed.


PPTL will ensure that contract or order requirements differing from those previously defined are resolved. The

customer requirements shall be confirmed by the organization before acceptance, when the customer does not

provide a documented statement of their requirements, example: an email or a purchase order as per the SOP Number

PPTL/SOP/CS/002.



8.2.3.2 The organization shall retain documented information, as applicable on the following:

• Results of the review (See Appendix X).

• Any new requirements for the products and services (See Appendix X).



8.2.4 CHANGES TO THE REQUIREMENTS FOR PRODUCTS AND SERVICES

PPTL shall ensure that relevant documented information is amended, and that relevant persons are aware of the

changed requirements, when the requirements for products and services are changed as stated in the SOP Number

PPTL/SOP/CS/002 – Receipt of Orders.



8.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES

This particular clause is not applicable to the PPTL QMS since the organization is not involved in design and
development of products and services. The fact that this particular clause is not applicable does not affect the


PPTL’s ability, or responsibility to ensure conformity of its products and services and enhancement of customer
satisfaction. We confirm the quality of the products we receive through our internal quality control activities as

stated in the SOP Number – PPTL/SOP/DH/002 – Receipt of Goods and through GMP Inspections that are

conducted by the TFDA.



8.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES

8.4.1 GENERAL

PPTL has put measures in place to ensure that externally provided processes, products and services conform to

requirements. The organization has determined the controls to be applied to externally provided processes, products

and services when:

• Products and services from external providers are intended for incorporation into the organization own

products and services.

• Products and services are provided directly to the customers by external providers on behalf of PPTL.

• A process or part of a process is provided by an external provider as a result of a decision made by PPTL.
















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PPTL has determined and applied a criterion for the evaluation, selection, monitoring of performance and re-

evaluation of external providers based on their ability to provide processes or products and services in accordance

with requirements. PPTL will maintain documented information of these activities and any necessary actions arising

from the evaluations as stated in the SOP Numbers PPTL/SOP/QA/011 – Subcontractor Management and
PPTL/SOP/BD/007 – Prequalification of Suppliers that is done at the Group/Headquarters Level.



8.4.2 TYPE AND EXTENT OF CONTROL

PPTL shall ensure that externally provided processes, products and services do not adversely affect the organization’s

ability to consistently deliver conforming products and services to its customers.

PPTL shall:


• Ensure that externally provided processes remain within the control of its QMS.

• Define both the controls that it intends to apply to an external provider and those it intends to apply to the
resulting output.


• Take into consideration:
o The potential impact of the externally provided processes, products and services on the organization’s

ability to consistently meet customer and applicable statutory and regulatory requirements;

o The effectiveness of the controls applied by the external provider;

• Determine the verification, or other activities, necessary to ensure that the externally provided processes,

products and services meet requirements as stated in the SOP Numbers PPTL/SOP/QA/011 – Subcontractor

Management and PPTL/SOP/BD/007 – Prequalification of Suppliers.



8.4.3 INFORMATION FOR EXTERNAL PROVIDERS

PPTL shall ensure the adequacy of requirements prior to their communication to the external provider. PPTL shall

communicate to external providers its requirements for:

• The processes, products and services to be provided.

• The approval of:

o Products and services.
o Methods, processes and equipment.


o The release of products and services.

• Competence, including any required qualification of persons.

• The external provider’s interactions with the organization.

• Control and monitoring of the external provider’s performance to be applied by the organization.

• Verification or validation activities that the organization, or its customer, intends to perform at the external
provider’s premises as stated in the SOP Numbers PPTL/SOP/QA/011 – Subcontractor Management and

PPTL/SOP/BD/007 – Prequalification of Suppliers.



8.5 PRODUCTION AND SERVICE PROVISION

8.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION

PPTL has implemented production and service provision under controlled conditions. Controlled conditions shall

include, as applicable:

• The availability of documented information that defines the characteristics of the products to be produced,

the services to be provided, or the activities to be performed example expiry date of products and the results

to be achieved. The procedures are maintained as SOPs and Quality Objectives are set the targets that are to

be met.

• The availability and use of suitable monitoring and measuring resources. The availability of Tally. ERP software

for tracking of customer orders, installation and implementation of Temperature Remote Monitoring System

for monitoring storage temperature of pharmaceutical products and a Turn Around Time Stamp for



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monitoring the service delivery timelines.

• The implementation of monitoring and measurement activities at appropriate stages to verify that criteria for

control of processes or outputs, and acceptance criteria for products and services, have been met. The

availability of Tally. ERP software for tracking of customer orders, signature approvals through each stage of
the supply chain, installation and implementation of Temperature Remote Monitoring System for monitoring


storage temperature of pharmaceutical products and a Turn Around Time Stamp for monitoring the service
delivery timelines.


• The use of suitable infrastructure and environment for the operation of processes.

• The appointment of competent persons, including any required qualification. This is achieved through the
Human Resource SOP Number PPTL/SOP/HR/001.


• The validation, and periodic revalidation, of the ability to achieve planned results of the processes for
production and service provision, where the resulting output cannot be verified by subsequent monitoring or

measurement., calibration of equipment shall be as stated in the SOP Number SOP/PPTL/DH/018.


• The implementation of actions to prevent human error example through availability of SOPs, recruiting
competent staff as stated in the SOP Number PPTL/SOP/HR/001 and also engaging Risk Based Process

Approach and Planning as per the SOP Number PPTL/SOP/QA/010.

• The implementation of release, delivery and post - delivery activities. This is achieved through SOP Number

PPTL/SOP/CS/003 for Handling Complaints, release of any pharmaceuticals products into the market shall only

occur if they are registered as per the SOP Number PPTL/SOP/RA,001, and cleared by QA as per the SOP

Number PPTL/SOP/DH/002 and PPTL/SOP/DH/004, and the orders going through the supply chain undergoes

release at each point of the chain as stated in the SOP Numbers PPTL/SOP/DH/008, PPTL/SOP/CS/002 and

PPTL/SOP/DH/020.



8.5.2 IDENTIFICATION AND TRACEABILITY

The organization shall use suitable means to identify outputs when it is necessary to ensure the conformity of

products and services. The organization shall identify the status of outputs with respect to monitoring and

measurement requirements throughout production and service provision.



The organization shall control the unique identification of the outputs since traceability is a requirement for all
pharmaceuticals and retains the documented information necessary to enable traceability in an electronic ERP system

and also invoice copies, all of these by the use of batch numbers. This is to ensure identification through the

supply chain as stated in the SOP Number PPTL/SOP/DH/008.



8.5.3 PROPERTY BELONGING TO CUSTOMERS OR EXTERNAL PROVIDERS

PPTL shall exercise care with property belonging to customers or external providers while it is under the organization’s

control or being used by the organization. The organization shall identify, verify, protect and safeguard customers’ or

external providers’ property provided for use or incorporation into the products and services. PPTL exercises care over

customer property when receiving, handling, storing and distributing the various pharmaceutical and healthcare

commodities. In the event of loss or damage this is reported to the customer retain documented information on what

has occurred.



8.5.4 PRESERVATION

The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure

conformity to requirements. Preservation will include identification, handling, contamination control, packaging,

storage, transmission or transportation, and protection.



Conformity of pharmaceutical drugs and healthcare commodities handled at PPTL is preserved during receiving,



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storage at the warehouse and during internal processing of orders as well as whilst in transit to the intended

destination by following WHO and EU GDP Guidelines. This includes identification, storage, handling, packaging and

protection as stated in the SOP Numbers PPTL/SOP/DH/002 – Receipt of Goods, PPTL/SOP/DH/004 – Receipt of Cold

Chain Goods, PPTL/SOP/DH/006 - Housekeeping, PPTL/SOP/DH/009 – Storage of Goods, PPTL/SOP/DH/010 –
Distribution Hub Mapping, PPTL/SOP/DH/011 – Handling Spillages, PPTL/SOP/DH/012 – Pest Control,


PPTL/SOP/DH/013 – Temperature and Humidity Monitoring, PPTL/SOP/DH/015 – Fate of Unfit Goods,
PPTL/SOP/DH/020 – Delivery of Goods and PPTL/SOP/DH/021 – Evolving GDP Guidelines.



8.5.5 POST DELIVERY ACTIVITIES

PPTL shall meet requirements for post-delivery activities associated with the products and services. PPTL accepts

returns from customers as stated in the SOP Number PPTL/SOP/DH/014 – Handling Returned Goods. In determining

the extent of post - delivery activities that are required, PPTL shall consider:


• Statutory and regulatory requirements.

• The potential undesired consequences associated with its products and services.
• The nature, use and intended lifetime of its products and services.


• Customer requirements, that are determined using different sources as stated in the Clause 4.2 and are
reviewed annually during the Management Review Meeting as stated in the SOP Number PPTL/SOP/QA/009.

• Customer feedback using the SOP Number PPTL/SOP/CS/003



Procedures for monitoring the effects of the products in the market is covered by a separate Quality manual

altogether – PPTL/QM/002 – Pharmacovigilance Quality Manual.



8.5.6 CONTROL OF CHANGES

PPTL shall review and control changes for production or service provision, to the extent necessary to ensure

continuing conformity with requirements. A procedure on change control, PPTL/SOP/QA/003 has been established to

ensure that all major changes related to the maintenance of the PPTL QMS and Good Distribution Practice are

reviewed, approved and communicated appropriately before implementation. PPTL shall maintain documented

information describing the results of the review of the changes, the person authorizing the change and the necessary

actions arising from the review.



8.6 RELEASE OF PRODUCTS AND SERVICES
PPTL shall implement planned arrangements, at appropriate stages, to verify that the product and service

requirements have been met. The release of products and services to the customer shall not proceed until the planned

arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as

applicable, by the customer. The organization shall retain documented information on the release of products and

services. The documented information shall include evidence of conformity with the acceptance criteria example: copy

of customer in comparison to the delivery note to customer and traceability to the person(s) authorizing the release

example: signatures stores and dispatch personnel releasing the order as stated in the SOP Number

PPTL/SOP/DH/007, PPTL/SOP/DH/008 and PPTL/SOP/DH/020. Release of any pharmaceuticals products into the

market shall only occur if they are registered as per the SOP Number PPTL/SOP/RA,001, and cleared by QA as per the

SOP Number PPTL/SOP/DH/002 and PPTL/SOP/DH/004, and the orders going through the supply chain undergoes

release at each point of the chain as stated in the SOP Numbers PPTL/SOP/DH/008, PPTL/SOP/CS/002 and

PPTL/SOP/DH/020. Any release of returns is controlled as stated in the SOP Number PPTL/SOP/DH/014.



8.7 CONTROL OF NONCONFORMING OUTPUTS

8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified and

controlled to prevent their unintended use or delivery. The organization shall take appropriate action based on the



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nature of the nonconformity and its effect on the conformity of products and services. This shall also apply to

nonconforming products and services detected after delivery of products, during or after the provision of services.



The organization shall deal with nonconforming outputs in one or more of the following ways:

• Correction.

• Segregation, containment, return or suspension of provision of products and services.

• Informing the customer.

• Obtaining authorization for acceptance under concession.

• Conformity to the requirements shall be verified when nonconforming outputs are corrected.


8.7.2 The organization shall retain documented information that:


• Describes the nonconformity.

• Describes the actions taken.

• Describes the concessions obtained.

• Identifies the authority deciding the action in respect of the nonconformity.


A documented procedure, Procedure for Control for Nonconforming Outputs – Handling Deviations

PPTL/SOP/QA/006 is in place to ensure that product and service which does not conform to requirements is

identified and controlled to prevent its unintended use or delivery. Non-conforming product and service is

dealt with in one of the following ways:

• By taking action to eliminate the detected nonconformity.

• By taking action to preclude its original use or application.



Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained,

are maintained. When non-conforming product is detected after collection, delivery, or use has started, Phillips

Pharmaceuticals (Tanzania) Limited takes action appropriate to the effects, or potential affects, of the

nonconformity. Procedures for monitoring the effects of the products in the market is covered by a separate

Quality manual altogether – PPTL/QM/002 – Pharmacovigilance Quality Manual.

























































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9.0 PERFORMANCE EVALUATION

9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION

9.1.1 GENERAL

The organization shall determine the following:


• What needs to be monitored and measured example: customer satisfaction, quality objectives
• The methods for monitoring, measurement, analysis and evaluation needed to ensure valid results.

• When the monitoring and measuring shall be performed example: annual customer survey, quarterly

monitoring of quality objectives

• When the results from monitoring and measurement shall be analysed and evaluated.



With a view to demonstrating conformity of the product or service, ensuring conformity of the quality

management system and continually improving the effectiveness of the quality management system, PPTL

plans and implements the monitoring, measurement, analysis and improvement processes using appropriate

methods including statistical techniques, such as bar charts and line graphs. PPTL shall evaluate the performance

and the effectiveness of the quality management system through an internal audit system as stated in the SOP

Number PPTL/SOP/QA/005, through management review as stated in the SOP Number PPTL/SOP/QA/009, handling

changes and deviations as per the SOP Numbers PPTL/SOP/QA/007 and PPTL/SOP/QA/006 respectively and through

customer satisfaction as stated in the SOP Number PPTL/SOP/CS/003. Individual performances shall also be monitored
as stated in the SOP Number PPTL/SOP/HR/005 that can affect the QMS implementation collectively. The organization


shall retain appropriate documented information as evidence of the results.


9.1.2 CUSTOMER SATISFACTION

PPTL shall monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled.

The organization shall determine the methods for obtaining, monitoring and reviewing this information. PPTL

monitors information relating to customer perception as to whether the organization has met customer

requirements in the following ways:

• Undertaking surveys to establish customers perception of the extent to which PPTL has met their

requirements as stated in the SOP Number PPTL/SOP/CS/003.

• Monitoring compliments from consumers and partners as stated in the SOP Number PPTL/SOP/CS/003.

• Monitoring customer complaints and concerns as stated in the SOP Number PPTL/SOP/CS/003.

• Monitoring data on product and service delivery as stated in the SOP Number PPTL/SOP/DH/008.



9.1.3 ANALYSIS AND EVALUATION

PPTL shall analyse and evaluate appropriate data and information arising from monitoring and measurement. PPTL

shall effectively collect and analyze appropriate data, determine the suitability and effectiveness of its QMS

and evaluate where continual improvement of the effectiveness of the quality management system can be

made. This includes data generated as a result of monitoring and measurement of various processes and from

other relevant sources. The Key Performance Indicators have been developed for key processes in the

organization and shall be monitored quarterly and then presented during the management review as s tated in
the SOP Number PPTL/SOP/QA/009.



In effect it analyses the data in order to provide information on customer satisfaction, conformance to

customer, product or service requirements, characteristics and trends of processes, products and services

including opportunities for preventive action, and suppliers

The results of analysis shall be used to evaluate:


• Conformity of products and services.

• Degree of customer satisfaction.


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• Performance and effectiveness of the QMS.

• If planning has been implemented effectively.

• Effectiveness of actions taken to address risks and opportunities.

• Performance of external providers.

• Need for improvements to the QMS.



9.2 INTERNAL AUDIT

9.2.1 PPTL shall conduct internal audits at planned intervals to provide information on whether the QMS is
effectively implemented and maintained and conforms to:


• The organization’s own requirements for its QMS.

• The requirements of this International Standard.


9.2.2 PPTL has done the following:


• Planned, established, implemented and maintained an audit programme(s) including the frequency, methods,
responsibilities, planning requirements and reporting, which takes into consideration the importance of the

processes concerned, changes affecting the organization, and the results of previous audits.

• Defined the audit criteria and scope for each audit.


• Selected auditors and conduct audits to ensure objectivity and the impartiality of the audit process; audits are
conducted by personnel other than those who perform the activity being audited.

• Ensured that the results of the audits are reported to relevant management.

• Taken appropriate correction and corrective actions without undue delay.

• Retained documented information as evidence of the implementation of the audit programme and the audit

results.



The documented procedure for Internal Quality Audits, PPTL/SOP/QA/005 includes the responsibilities and

requirements for conducting audits, ensuring their independence, recording results and reporting to

management.



Management ensures that timely corrective action is taken on deficiencies found during the audit. Follow up
action includes the verification of the implementation of corrective action, and the reporting of verification


results.


9.3 MANAGEMENT REVIEW

9.3.1 GENERAL

PPTL top management shall review the organization’s QMS, at planned intervals, to ensure its continuing suitability,

adequacy, effectiveness and alignment with the strategic direction of the organization. The Director in conjunction

with top management, QMR and appropriate staff, review the PPTL QMS at planned intervals of at least twice a

year to ensure its continuing suitability, adequacy and effectiveness and alignment with the strategic direction

of the organization. The review is for improvement and the need for changes to the system and to verify that

the quality policy and objectives are being satisfied. The meeting is arranged by the QMR and chaired by the

Director. Other personnel may attend where necessary to provide relevant input.



9.3.2 MANAGEMENT REVIEW INPUTS

The management review shall be planned and carried out taking into consideration the following:

• Status of actions from previous management reviews.

• Changes in external and internal issues that could affect the QMS.

• Information on the performance of the PPTL QMS, including:



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o Customer satisfaction and feedback from relevant interested parties.

o The extent to which quality objectives have been met.

o Process performance and conformity of products and services.

o Non - conformities and corrective actions.
o Monitoring and measurements results.


o Audit results.
o Performance of external providers.


• The adequacy of resources.

• The effectiveness of the actions taken to address risks and opportunities.

• Opportunities for improvement.


9.3.3 MANAGEMENT REVIEW OUTPUTS

The outputs of the management review shall include decisions and actions related to:


• Opportunities for improvement.
• Any need for changes to the QMS.


• Resource needs.


The QMR maintains the records of the review which includes observations, conclusions and recommendations

made as a result of such review. Minutes of the meeting are signed as approved by the Director and retained as

a quality record with all agreed actions monitored and results recorded as stated in the SOP Number

PPTL/SOP/QA/009 – Management Review.














































































P a g e 26 | 28

QUALITY MANUAL





PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED



DOCUMENT NUMBER ISSUE NUMBER SUPERSEDES EFFECTIVE DATE

PPTL/QM/001 02 01 14.12.2018



10.0 IMPROVEMENT

10.1 GENERAL

PPTL shall determine and select opportunities for improvement and implement any necessary actions to meet

customer requirements and enhance customer satisfaction. These shall include:


• Improving products and services to meet requirements as well as to address future needs and expectations.
• Correcting, preventing or reducing undesired effects.

• Improving the performance and effectiveness of the QMS.



PPTL plans and organizes how to continually improve its QMS. Continual improvement of the QMS is facilitated

through the use of the Quality Policy, Quality Objectives, Audit Results, Analysis of Data, Corrective and

Preventive Actions and Management Review, Projects and Re-Organization.



10.2 NONCONFORMITY AND CORRECTIVE ACTION

10.2.1 When non-conformity occurs, including any arising from complaints, the organization shall:

• React to the nonconformity and, as applicable:

o Take action to control and correct it.

o Deal with the consequences.

• Evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or

occur elsewhere, by:

o Reviewing and analysing the nonconformity.

o Determining the causes of the nonconformity.

o Determining if similar nonconformities exist or could potentially occur.

• Implement any action needed.

• Review the effectiveness of any corrective action taken.

• Update risks and opportunities determined during planning, if necessary.

• Make changes to the quality management system, if necessary.

• Corrective actions shall be appropriate to the effects of the nonconformities encountered.


PPTL establishes and maintains a nonconformity and corrective action program to eliminate the cause of

nonconformities in order to prevent recurrence. Corrective action appropriate to the impact of the problems

encountered is appropriately carried out.



The documented procedure PPTL/SOP/QA/006 for nonconformity and corrective action defines requirements

for identifying and reviewing nonconformities including customer complaints, determining the causes for

nonconformities and evaluating the need for actions to ensure that nonconformities does not recur. In

addition, it defines requirements for determining and implementing the corrective action needed, recording

results of action taken as well as reviewing the effectiveness of the corrective action taken.



10.2.2 The organization shall retain documented information as evidence of:


• Nature of the nonconformities and any subsequent actions taken.
• Results of any corrective action.



10.3 CONTINUAL IMPROVEMENT

The organization shall continually improve the suitability, adequacy and effectiveness of the quality management

system. The organization shall consider the results of analysis and evaluation, and the outputs from management

review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.




P a g e 27 | 28

QUALITY MANUAL





PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED



DOCUMENT NUMBER ISSUE NUMBER SUPERSEDES EFFECTIVE DATE

PPTL/QM/001 02 01 14.12.2018



11.0 AMENDMENT LOG




DATE ISSUE NUMBER SECTION NUMBER AMENDMENT REASON FOR AMENDMENT


1
ST
SEPTEMBER 01 FULL MANUAL NEW MANUAL TO CATER FOR REQUIREMENTS
OF THE ISO 9001 QMS
2018















































































































P a g e 28 | 28

Appendix I: Mission, Vision and Core Values




PPTL Vision Statement


• The Preferred Provider of Affordable, Sustainable and Innovative Healthcare
Solutions for a Healthy Tanzania.



PPTL Mission


• To Improve the Quality of Life, Productivity and Dignity of the Tanzanian people

through Outstanding Healthcare Solutions.

• To Develop Reliable Strategic Partnerships and Maintain a Sustainable Marketing

System that ensures Access to Affordable and High-Quality Products.


• To Retain and Nurture a Highly Industrious, Self-Motivated and Dedicated Team.


PPTL’s Core Values


The guiding values applied by the management of PPTL to accomplish this mission are the

following:

• Customer Focus


• Teamwork & Synergy

• Quality & Innovation

• Professionalism

• Continuous Improvement














































Quality Management System Tool – Mission, Vision and Core Values, PPTL/QMS/QA/029 Issue Number 01

Appendix II: External Issues That Could Affect PPTL Quality Management System




• Changes in the ISO Standard Requirements that need to be implemented.

• Changes in Regulatory Requirements from the Ministry of Health (MoH), Pharmacy Council (PC)

and Tanzania Food and Drug Authority (TFDA).

• Standardization and Certification Requirements within the Pharmaceutical Industry.

• Requirements from entities that have Subcontracted PPTL to distribute as well as those from their
Principals.

• Changes in Current Good Distribution Practice (GDP) Guidelines from TFDA/EU/WHO.

• Government of Tanzania (GT) Regulations.

• Results of External Audits.

• Services and Products provided by External Service Providers.

• Customer Expectations.

• Competitive Environment i.e. Other Suppliers.
• Technological Changes.

• Economic Backdrop.

• Cultural and Social Issues.






























































Quality Management System Tool – External Issues, PPTL/QMS/QA/019 Issue Number 01

Appendix III: Internal Issues That Could Affect PPTL Quality Management System






• New Business Opportunities.

• New Business Partnerships.
• Contractual Arrangements with Customers.

• Service Level Agreements.

• Structure of the Organization and Reporting Structures.

• Roles within the Organization.

• Staff Retention and Stability of Workforce.

• Culture within the Organization.

• Availability of Reliable Qualified and Competent Workforce.
• Change in Operating ERP System.








































































Quality Management System Tool – Internal Issues, PPTL/QMS/QA/020 Issue Number 01

Appendix IV: Interested Parties and Their Requirements




INTRESTED EXPECTATIONS NEEDS

PARTY

• Ensure Regulatory Licenses for
Ministry of the Premises are Valid.

Health, • Ensure Key Staff have Valid

Pharmacy Licenses.

Council and • Dissemination of News • Ensure Products have a Valid

Tanzania adequately. Registration Certificate.

Food and • Ensure All Imported Products
Drug have Valid Permits.

Authority • Ensure All Clients have Valid

Registrations.


• Ensure all Statutory Payments are
Tanzania Dissemination of News made on time.

Revenue • adequately. • Ensure all Customers are issued

Authority an EFD Receipt upon any

Purchase.

• Where a Quality Agreement is

in place, ensure the

Requirements stipulated are
met. • Ensure Goods are Stored and
Transported as per their
• Ensure Goods are Stored and Recommended Conditions.
Transported as per their

Recommended Conditions. • Ensure Goods are supplied to
Approved Clients Only.
• Ensure appropriate shipping Where a Quality Agreement is in

information is shared with the •
All Principals place, ensure the Requirements
clearing agents, especially Cold
Chain Products. stipulated are met.
Ensure Security of their Products.
• Ensure Timely Payments against • Ensure Records are maintained in
the raised Debit Notes. • a Good Secured Location.


• Ensure all Regulatory Ensure Timely Payments are
Requirements are met •

appropriately and maintain made.

constant communication with

our Regulatory Staff.

• Ensure Timely Payments are
made as per the agreed terms Ensure Timely Deliveries.

and conditions. • Ensure Concerns and Complaints


• Ensure Feedback is given so as • are handled appropriately and on
to improve our processes.

All Customers • Report any Adverse Events as time.

per the statutory timelines. • Ensure there is Good

• Ensure Goods are Stored and Communication.
Ensure the Customer Relation is
Transported as per their • respected at all times.

Recommended Conditions.


• Ensure there is Good

Communication.

• Provide services to customers Job Security.

as per our standards. • Timely Salary.

• Follow Quality Management • Trainings.
System Policies and Procedures. • Proper Working Conditions.

Staff • Observe Discipline and Respect • Personal Protective Clothing

at work place. • available (where applicable).

• Be problem solving and Appreciation, Recognition and

innovative within the • Reward.

organization.

• Must have Valid Registration

Certificate.

• Ensure the staff of the third
party vendor follows the Health

and Safety Guidelines and all

other applicable statutory

guidelines.

• Ensure timely treatments • Ensure the Bait Stations are

against domestic insects and accessible at all times and are
Third Party rodents. protected from damage.

Vendor – Pest • Ensure that the insecticides and • Ensure there is Good

Control Agent rodenticides are registered with Communication.

Tropical Pesticides Research • Ensure timely payments for the

Institute (TPRI) and are services delivered.

supported by Material Safety

Data Sheets (MSDS).

• Ensure there is Good

Communication.

• Ensure Concerns and
Complaints are handled

appropriately and on time.


• Must have Valid Registration
Certificate.

• Ensure the staff of the third

party vendor follows the Health
and Safety Guidelines and all Ensure Receiving Area is clean

other applicable statutory •

Third Party guidelines. and empty for Offloading and

Vendor – • Ensure goods are delivered Handing Over.

Clearing and within the company’s timelines. • Ensure the vehicles are offloaded

Forwarding • Ensure goods are transported as soon as they arrive at the

Agent within a temperature controlled premise.
Ensure timely payments for the
vehicle. • services delivered.

• Ensure the goods are protected
from damage during transport.


• Ensure no deliveries are made
after working hours except for

cold chain products.

• Ensure the staff is trained on
how to handle pharmaceuticals

products especially cold chain

products.


• Ensure there is Good
Communication.

• Ensure Concerns and

Complaints are handled

appropriately and on time.

• Must have Valid Registration
Certificate.


• Ensure the staff of the third
party vendor follows the Health

and Safety Guidelines and all

other applicable statutory

guidelines.
Third Party • Ensure that no staff tampers with

Vendor – • Ensure timely servicing of the the equipment without prior
equipment and provide service
Maintenance reports after each delivery of knowledge.

of Air • Ensure there is Good

Conditioners service. Communication.

and Cold • Ensure the staff is trained • Ensure timely payments for the

Rooms appropriately. services delivered.
• Ensure lead times are respected

in case of any emergency.

• Ensure there is Good

Communication.

• Ensure Concerns and
Complaints are handled

appropriately and on time.


• Must have Valid Registration
Certificate.

• Ensure the staff of the third

party vendor follows the Health

and Safety Guidelines and all

other applicable statutory
guidelines. • Ensure that no staff tampers with


• Ensure timely servicing of the the equipment without prior
Third Party equipment and provide service knowledge.

Vendor – IT reports after each delivery of Ensure there is Good
Support and service. • Communication.

Maintenance
• Ensure the staff is trained • Ensure timely payments for the

appropriately. services delivered.

• Ensure lead times are respected
in case of any emergency.


• Ensure there is Good
Communication.

• Ensure Concerns and

Complaints are handled

appropriately and on time.

• Must have Valid Registration

Certificate.

• Ensure the staff of the third
party vendor follows the Health

and Safety Guidelines and all

other applicable statutory

guidelines. Ensure that no staff tampers with

Third Party • Ensure timely servicing of the • the equipment without prior

Vendor – equipment and provide service knowledge.
Maintenance reports after each delivery of Ensure there is Good

of service. • Communication.

Photocopier • Ensure the staff is trained Ensure timely payments for the

Machine appropriately. • services delivered.

• Ensure lead times are respected

in case of any emergency.

• Ensure there is Good

Communication.

• Ensure Concerns and
Complaints are handled

appropriately and on time.


• Must have Valid Registration
Certificate.

• Ensure the staff of the third

party vendor follows the Health

and Safety Guidelines and all

other applicable statutory • Ensure the products that are to

guidelines. be disposed are kept in an
organized manner and an
• Ensure that no products are updated schedule for the same.
Third Party exposed to unauthorized

Vendor – personnel. • Ensure all other regulatory and

Disposal of • Ensure that no products are left statutory requirements have

Products undisposed at the end of the been completed.

disposal exercise. • Ensure there is Good
Communication.
• Ensure the staff is trained Ensure timely payments for the
appropriately. • services delivered.


• Ensure there is Good
Communication.


• Ensure Concerns and
Complaints are handled

appropriately and on time.













Quality Management System Tool – Interested Parties & Requirements, PPTL/QMS/QA/021 Issue Number 01

Appendix V: Interaction of PPTL Processes







QUALITY MANAGEMENT PROCESSES





Management

Responsibility Resource Management, Product


Management Control of Control of Realization, Measurement,
Responsibility Documents Records Analysis, Improvement and Risk

Management









CORE BUSINESS PROCESSES











Purchasing, Warehousing,
Customer Customer
Distribution, Order
Requirements Management & Customer Satisfaction


Service







CRITICAL SUPPORT PROCESSES







Business Human Finance & Regulatory/ Administrati
Development Resource Accounts Compliance on & IT QA & PV














OUTSOURCED SERVICES



Pest Control, Calibration, Service of Cold Room,

Disposal of Commodities, Clearing and Forwarding, IT Maintenance












Quality Management System Tool – Process Flow Chart, PPTL/QMS/QA/022 Issue Number 01

Appendix VI: PPTL Quality Policy



Phillips Pharma Group Tanzania is committed to provide High Quality Health Care Products


within Tanzania. The Company has developed its expertise since its establishment and its aim is

to innovatively improve access and optimize supply of quality healthcare products to its

customers.




The Directors, Management and Staff are responsible for Quality Assurance through the Quality

Management System, seeking improvement in all spheres of activities by constant review and

nurturing a genuine team spirit within the organization. The Company is committed to achieving


customer satisfaction by the use of quality procedures which will be implemented to meet or

exceed the requirements of ISO 9001 as well as meeting statutory and regulatory requirements.








































































Quality Management System Tool – Quality Policy, PPTL/QMS/QA/023 Issue Number 01

Appendix VII: PPTL Sera ya Ubora (Quality Policy)



Phillips Pharmaceuticals (Tanzania Limited imejizatiti katika kutoa huduma bora za uhifadhi na


usambazaji wa bidhaa bora za afya kinga nchini Tanzania. Kampuni imejijenga kiuwezo tangu

kuanzishwa kwake ikiwa na lengo kuu la kuboresha upatikanaji na usambazaji wa bidhaa bora za

afya kinga kwa wateja wake.




Wakurugenzi, Utawala na wafanyakazi wote wanahusika kwa dhati katika uhakikishaji wa ubora

kupitia mfumo wa usimamiaji ubora, ikilenga uboreshaji katika majukumu yao ikiwa ni pamoja

na kupitia na kujenga hamasa ndani ya kampuni.




Kampuni imejizatiti kutimiza na kukidhi maitaji ya wateja wake kwa kutumia taratibu za ubora

ambazo zitasaidia kutimiza maitaji ya ubora ya ISO 9001, ikiwa ni pamoja na kukidhi maitaji ya

kisheria na ya uthibiti.



































































Quality Management System Tool – Quality Policy, PDL/QMS/QA/023 Issue Number 01

Appendix VIII: PPTL Organogram
































































































































Quality Management System Tool – Organogram, PPTL/QMS/QA/024 Issue Number 01

Quality Management System Tool – Organogram, PPTL/QMS/QA/024 Issue Number 01

Quality Management System Tool – Organogram, PPTL/QMS/QA/024 Issue Number 01

Quality Management System Tool – Organogram, PPTL/QMS/QA/024 Issue Number 01

Quality Management System Tool – Organogram, PPTL/QMS/QA/024 Issue Number 01

Quality Management System Tool – Organogram, PPTL/QMS/QA/024 Issue Number 01

Quality Management System Tool – Organogram, PPTL/QMS/QA/024 Issue Number 01

Appendix IX: PPTL Quality Objectives






Evidence of Achieving Objective Certificate Results from Customer Feedback Survey Results from Turn Around Time KPI Results from the Accounting Numbers



















Resources - Information Technology Customer Relations Training Information Technology Man Power
PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED










Deadline 30.03.2019 31.12.2019 31.12.2019 31.12.2019










Responsibility Organization Organization Distribution and Customer Support Department Accounts and Finance Department










Quality Management System Tool - Quality Objectives of the Organization, PPTL/QMS/QA/026 Issue Number 01




Improve Complain Handling
Improve Debt Collection





Action Implement ISO Standards Improve Customer Relations Improve Delivery Timelines Improve Tender Supplies Improve Delivery Timelines





















Objective ISO 9001 Certification 80% Customer Satisfaction 50% Deliveries Within 24 Hours 10% Reduction in Outstanding Payments
















SN 1 2 3 4



Quality Management System Tool – Organogram, PPTL/QMS/QA/024 Issue Number 01

Appendix X: Review of Requirements for Products and Services





GENERAL REQUIREMENTS FOR PRODUCTS AND SERVICES




CUSTOMER REQUIREMENTS


• Improve on Timely Deliveries and especially

Response to Urgent and Emergency Orders.

• Communication on Expiry Date of Products
especially those that are Short Dated.

• Communication on Out of Stock Items and

Confirmation on holding Back Orders.

• Timely Communication of Back to Stock Items and

advice on Pending Orders.

• Communication on Delays on Distribution and
Action being taken.


• Transport of Products at the Recommended
Temperature.


• Contact Person to respond to Customer Issues and
need to resolve them as they arise to Conclusion


Distributors, Hospitals, Pharmacies and within Timely Manner.

and Other Customers • Need to confirm that Customers have received their

Orders especially Upcountry Clients in Good Order


and Condition.

• Established Mechanism for support of handling

Short Expiry/Dead Stock at Customers.


• Timely Feedback on Returns and Process

Finalization (Credit Notes Generation)

• Maintain enough Stock Levels for Accounts that are

under PPTL.

• Flexible Payment Terms for Accounts that are under

PPTL.

• Communicate if Order will not be delivered for
Whatever Reason.


• Process Orders accurately.

• Address Issue of Cancelled Orders.

• The consignment needs to be accompanied by
Action Medeor International Certificate of Analysis for each batch of the product

Healthcare Limited that we are supplying.

• As above.

• The consignment requests need to be met on timely

manner.

• Stock take on the consignment stock need to be
The Agakhan Hospital – Dar es Salaam
done on a monthly basis and reconciliation with
their inventory system needs to be completed

immediately.

• The quantities that have been used shall be invoiced
and replenishments made for the same.


• Temperature Reports for all Cold Chain Reports
need to accessible when required by the Quality

Team.

• The consignment for Phillips Pharma Sister

Companies to be separated during delivery.

• Others as above.

• Deliveries to be made on Friday before 12 noon.
Zanzibar Customers
• Others as above.

• The delivery notes for the supplies need to written

with Generic Medicine Names.

• Two Years Plus Remaining Shelf Life for all products.
A commitment letter is needed incase otherwise.

• The consignment needs to be accompanied by
Medical Stores Department (MSD) and Certificate of Analysis for each batch of the product
Muhimbili National Hospital (MNH)
that we are supplying.

• The consignment needs to be segregated and

labeled as per their distribution plan provided.

• Deliveries to be made before 12 noon.

• Others as above.
Vital Supplies, Tegeta Mission, CCBRT, • Deliveries to be made on weekdays only.

MSD, MNH • Others as above.

Data Reviewed From:




1. Communication with the Customers.
2. Ongoing Feedback from the Customer Concerns and Complaints.

3. External Audits.







































Quality Management System Tool – Review of Requirements, PPTL/QMS/QA/025 Issue Number 01

A CONTROLLED COPY