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PHARMA PRO & PACK | APRIL - JUNE 2021 47
TECHNOLOGY 5 Ways to Increase Capacity
Despite Talent Shortages with Digital
Manufacturing Technology
What a difference a few months make. easier to capture, manage and validate standard
With vaccina on roll out accelera ng work. They can also help improve opera onal
and a new s mulus bill just signed, the flexibility. For example, automated video and task-
U.S. economy looks likely to heat up soon. And when structure analysis is an efficient way to monitor
it does, talent shortages will remain a challenge. work in progress and validate KPIs for baseline
Mul ple factors will drive the ongoing challenges. metrics. Video-based digital manufacturing
People looking for a change of pace and be er technologies, such as AviX, underpin these efforts.
opportuni es following a stressful year. Con nued AviX allows engineers to drag and drop tasks
absences and turnover related to family illness or between posi ons and reconfigure workloads to
jobless benefits. And a reshaped business world op mize how lines are balanced and drive efficiency
following a year of unprecedented circumstances. and produc vity. These combined capabili es also
make it easier to proac vely develop a variable
Finding the right candidates may be increasingly staffing model and standard work combina ons for
difficult in the near term, but that doesn't mean different scenarios, so you are ready with a game
you're stuck with your current capacity. There are plan no ma er what the day looks like.
plenty of opportuni es to do more with less right
now using digital technology for opera onal and 2. Automate onboarding and training to get more
talent management processes. Just consider that out of your exis ng resources
digital technology can help you streamline
onboarding and training. Moreover, the same When it comes to ge ng new employees up to
technologies manufacturers rely on to rebalance speed or exis ng employees trained on new tasks,
lines and monitor processes can o en help pinpoint digital technologies come with a host of advantages.
areas for improving opera onal excellence. Rather than requiring face-to-face me with
trainers, for instance, employees can use digital
Let's explore 5 ways digital manufacturing training solu ons any me and virtually anywhere.
technology can help you increase capacity in the Moreover, they are rela vely easy to customize for
face of talent shortages. specific departments, roles or even lines. Through
the use of a standardized digital training process,
1. Establish clear standards for task comple on, including modules that incorporate standard or job-
work valida on and line balancing while increasing specific videos, employees can learn even when
opera onal flexibility quaran ned. That also means there is less of a
burden on trainers and managers. You can even
Digital manufacturing technology solu ons make it incorporate ways to provide remote coaching,
upskilling or cross training to keep your organiza on
moving forward under any circumstances.
3. Adopt a digital KPI strategy to more easily keep
goals on track
Real- me visibility into what's happening with KPIs
in your organiza on can be game changing. With the
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TECHNOLOGY help of digital KPI management, you can not only Digital manufacturing
be er ensure that you hit daily targets, but you also technology solu ons make it
get a window into workforce-related stats, such as easier to capture, manage
absenteeism. These insights can help you and validate standard work.
understand your true capacity so you can make They can also help improve
adjustments to meet capacity in the near term while
working to build up and increase capacity over the opera onal flexibility.
longer term. Best of all, KPI management so ware, For example, automated
like Dploy Solu ons, is affordable and helpful on video and task-structure
mul ple levels. analysis is an efficient way
to monitor work in progress
l Establish benchmarks that e directly to desired
business outcomes and validate KPIs for
baseline metrics. Video-
l Monitor produc on indicators in real me based digital manufacturing
l Provide floor managers clear visibility into technologies, such as AviX,
underpin these efforts.
processes so they can see dips that indicate
opera onal issues and iden fy their root causes. workflows, such as for maintenance requests or
task tracking, can also help alleviate redundant and
4. Monitor and measure workflows for con nual
fine tuning me-consuming processes that hold up produc on.
The more you can see into your processes, the more It's true that this type of automa on requires a
opportuni es you can poten ally iden fy to bigger investment, but the poten al ROI is also
increase capacity with the resources you have in significant; it can reduce full- me labor
place already. Workflow analy cs solu ons provide requirements by up to 25% while improving
ways to iden fy baseline produc vity as well as produc vity per hour by roughly the same amount.
establish a digital thread throughout processes, And that's with the added benefit of significant
from product design through produc on and quality improvements. When approached correctly,
beyond. Once you have a digital thread, you can automa on solu ons can pay for themselves in just
more easily analyze the poten al root causes of a few short years. Best of all, you can deploy the full-
process hiccups, which could be two or three steps
earlier in the produc on process than you originally me employees who are liberated from the line to
thought. A digital thread even enables you to model different areas of the opera on to fill other human
and simulate solu ons, so you can understand the capital needs, crea ng wins all the way around.
poten al results they will deliver before you commit
to change. Source: Ken Koenemann, Shannon Gabriel - Dploy
Solu ons (www.dploysolu ons.com).
5. Maximize output with a digital management
system and process automa on (Dploy Solu ons is registered trademarks of
TBM Consul ng Group)
When it comes to increasing capacity in the face of
staffing shortages, process automa on can pay
significant dividends. A er all, automa on can
reduce mundane tasks and free up personnel to
focus on more important things. For example, a
factory floor connec vity or IIoT equipment
monitoring solu on could help streamline
equipment monitoring tasks. Automa ng digital
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SUPPLY CHAIN Why should India adopt IoT for
the pharma supply chain?
Karen Ravindranath, Director, WebNMS - The Let us discuss the
IoT division of Zoho Corp. outlines how IoT
implementa on can help ramp up efficiency, various stages of
quality assurance and customer sa sfac on in the
pharma supply chain the supply chain
Healthcare and pharma industries have always been like manufacturing,
crucial to the economy and human welfare.
However, with the pandemic affec ng markets and warehousing and
people across the globe and the need for
unexpected demand for life-saving drugs and new distribu on and
research for vaccines, the pharma industry is seeing
an accelera on in its growth trajectory. logis cs where IoT-
India has been a leading player in the global pharma powered remote
industry, in terms of generic medicines. It has been a
major supplier of crucial medicines for some of the monitoring and
developed countries like the US, European countries
and Japan. However, China s ll holds a major share automa on can Karen Ravindranath,
of the pharma supply chain. With more than 70 per ins l a profound Director, WebNMS
cent of the global supply of raw materials and APIs difference in the
coming from China, the pandemic and its a ermath
has led to many companies rethinking their way the opera ons
dependence on a single provider and is looking to
diversify its supply chain. are carried, even during a global crisis.
India, already one of the top players, can capitalise Manufacturing: Considering medicines deal with
on this opportunity to further empower the pharma lives, it is highly essen al for pharma companies to
industry with reliability, quality and supply chain produce drugs at good quality and maintain
transparency to have a leading edge in the future. standards and government regula ons. Digi sing
the manufacturing process by using IoT applica on
Quality above everything for the pharma business and ge ng mely data can help iden fy
discrepancies early. This will ensure the quality and
The pharma industry, with its strict compliance effec veness of the drugs produced.
policies and approvals from the FDA and other
agencies, is always under pressure to deliver op mal Automa on in processing and packaging, along with
quality. The industry deals with lifesaving drugs and con nuous monitoring with IoT, will help create
in case of any deviance in quality, the brand visibility into the process. It will also make the
reputa on and lives at large could be at stake! process data available online for higher
management and administra ve staff who are
Therefore, right from manufacturing and storage to working remotely.
distribu on, various stages of the pharma supply
chain need to be under constant monitoring in order Tes ng and quality assurance take a different level
to track discrepancies and curb any damage. IoT can when they are backed by process and
empower the pharma supply chain with con nuous manufacturing data. It is easier to iden fy and
monitoring, predic ve maintenance and remote rec fy issues or problems in quality by looking into
automa on that can save millions of dollars lost on the wealth of process data and help avoid such
reac ve maintenance, unexpected down me, errors in future.
delays and costly loss of approvals due to
underqualified medicines. Warehouse and storage: Once the products are out
of the manufacturing units, it is highly cri cal to
52 PHARMA PRO & PACK | APRIL - JUNE 2021 store them at a conducive environment in the
warehouse. Various aspects of the warehouse
environment like temperature, humidity, safety and
hygiene can be monitored and managed using IoT
applica ons. Moreover, data from manufacturing
can be effec vely connected to warehouse data in
order to plan storage ahead and also align staff and
other supply chain processes for smooth transfer of
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SUPPLY CHAIN products from one stage to another. Considering the supply chain staff for loading and unloading can
crucial mes such as the recent pandemic which be managed using IoT solu ons which are simple
requires the safety of staff and restricted and effec ve visual applica ons. They can also
movements, automa on and proac ve data from engage field staff on the move with features to track
the warehouse can help them stay on the vigil and loca ons, hospital visits, safety and other major
also be alerted in case of any opera onal snag. factors that are crucial for business and
management.
Logis cs and distribu on: Safe movement and
delivery of medicines are as important as IoT for enterprise-wide management in pharma
maintaining the quality during manufacturing and business
storage. When there is a spike in demand for life-
saving drugs, especially during such unexpected Data is the biggest asset. With IoT to connect
COVID -19 situa ons, it is important that pharma mul ple aspects of the pharma supply chain, it is
companies equip themselves with prompt logis cs only fair that the data obtained from various stages
and distribu on. benefit the be erment of en re business
opera ons. IoT can connect the data siloes of the
The advantage of using IoT in the pharma supply different stages discussed, like manufacturing,
chain business is that it isn't restricted only to storage and distribu on, centralise the process and
sta onary assets and opera ons. It can be a major also offer valuable insights for the management to
game-changer in pharma logis cs and distribu on. create be er opera onal and business prac ces.
Be it safety, consignment tracking, order tracking or Apart from centralising the supply chain opera ons,
organising and managing field staff, IoT applica ons a good IoT applica on should be able to connect the
can be used for different purposes within the data with other enterprise applica ons like CRM
industry. There are IoT applica ons to monitor the and ERP will offer an enterprise-wide orchestra on
temperature and other aspects of drugs on the of data that can offer seamless communica on
move by con nuously monitoring the storage units between teams even during limited workforce
of vehicles that transport the drugs. Besides, major availability and unforeseen crisis.
factors like loca on of fleet, es mated me of
arrival, fleet capacity, product capacity planning, Source: Express Pharma
distribu on planning and even task alloca on for
54 PHARMA PRO & PACK | APRIL - JUNE 2021 www.ipmma.org
www.ipmma.org PHARMA PRO & PACK | APRIL - JUNE 2021 55
REGULATORY Good Distribution Practice (GDP) - Q&A
In October 2020, the European GDP Associa on personnel considered to be involved in wholesale
(ECA) offered the Live Online Training "The GDP distribu on ac vi es?
Compliance Manager". During the Q&A
sessions, many interes ng ques ons were posed to A: This is very dependent on the nature and
the speakers' team. The ECA shares a selec on of structure of the company along with how the
these Q&As sorted by topic. company is established in rela on to roles and
responsibili es. Examples may include sales and
Below you will find the third set of ques ons which marke ng, opera ons, finance, recep on,
have been answered by the speakers' team. All warehousing, transporta on, quality department,
answers reflect the opinion of the speakers based on human resources, customer services.
their experience.
Q: Can one Quality Policy be covering mul ple
Quality Management System (QMS) companies (e.g. one for several affiliates) or should
every company owning a wholesale license have an
Q: Do you think a change control (CC) is required for individual quality policy?
updates (including minor administra ve revisions)
to an SOP even if the document already has a A: Usually a company has one Quality Policy
revision history sec on? covering the Head Office and their affiliates. As long
as the policy is relevant to all affiliates, then there is
A: This should be defined in your documenta on no problem. A Quality Management System should
policy/procedure. Some companies choose to use not be confused with Quality Policy.
CC for document management; however, this may
not be needed nor be appropriate for all Q: If corporate procedures are available, can they be
organisa ons, you can use document history no implemented as such by an affiliate or are specific
problem and this is more manageable for most local procedures required?
organisa ons.
A: Yes. It depends on the companies' organisa on
Q: What is a Site Master File (SMF) in the context of and their document hierarchy regarding which
GDP? Is it the same as a Quality Manual or does it ac ons need to be taken. As long as all affiliates are
require to establish a separate SMF if we have a part of the same quality system then
Quality Manual? implementa on of Corporate Procedures might be
feasible. Again: Depending on the defined
A: SMF should provide full picture of the company's document hierarchy and how each of the affiliates is
ac vi es and how it is managed. Usually, a SMF is set up to operate. Specific local procedures should
not seen in a wholesale environment as the Quality be in use where Corporate Procedures are not
Manual will usually suffice. Where wholesale sufficient to cover differences in affiliate ac vi es.
ac vi es are undertaken by a manufacturer then a These procedures should cons tute the company
SMF will be in place. However, the requirements of QMS and follow the same format. Guidance can be
your competent authority should be followed. sought from the owners of the Corporate
Procedures.
Q: Could you provide examples of departments with
56 PHARMA PRO & PACK | APRIL - JUNE 2021 www.ipmma.org
Q: Is it acceptable if we work with KPI's rather than or broad, focusing on a specific area or the whole of REGULATORY
quality objec ves? the organisa on's ac vi es. With regards to GDP,
ensuring Self-Inspec on is performed is the
A: The GDP guidelines referred to quality system responsibility of the RP and the schedule needs to
objec ves and not KPI's; however, you may call them cover all the GDP ac vi es undertaken, cross-
whatever you like as long as the metrics within the referencing to the EU GDP Guidelines, reviewing
guidelines are reviewed and GDP ac vi es are processes, procedures, staff understanding etc.
incorporated into your review process.
Q: Can QA role be delegated to opera on person or
Q: What is the difference between Internal Audit person other than QA?
and Self-Inspec on?
A: Due to the varying sizes of wholesalers to whom
A: These terms tend to be used interchangeably and GDP regula ons and guidance are applicable, the
have different defini ons in different companies GDPs do not define which department personnel
and different countries. The important part to must work within. Therefore, it is the responsibility
remember is that you must, as per the GDP of the individual wholesaler to assess the right
guidelines, have implemented a process to rou nely person for the right role and ensure their
review compliance with all aspects of GDP, competence and ability to perform that role.
regula ons, guidelines and internal procedures. An
Internal Audit could be performed by the RP or Source: European GDP Associa on
another department and the scope could be limited
OBITUARY
IPMMA offers its deepest condolences for the loss of
Shri Jayan lal R. Mevada Shri Milan Mistry Shri Vijay Naidu
(1944 - 2021) (1966 - 2021) (1967 - 2021)
Director
Chairman & Founder Ambica Pharma Machines Pvt. Ltd. V M Services
Brothers Pharmamach
(India) Pvt. Ltd.
www.ipmma.org PHARMA PRO & PACK | APRIL - JUNE 2021 57
NEWS Indian pharma exports grow at 18% to
$24.44 billion in FY 21 from $20.58 bn
Pharma exports from India
witnessed over 18 per cent
growth to USD 24.44 billion
during the last financial year against
USD 20.58 billion in FY20,
Pharmaceu cals Export Promo on
Council of India (Pharmexcil) said on
Saturday.
"We have observed a big leap in our North America is the largest expor ng region for
exports in the month of March 2021 Indian pharmaceu cals with more than 34 per cent
which is USD 2.3 billion (figures for share.
March are provisional) and is highest among the
exports of all the months of this financial year, the Country wise exports to the US, Canada and Mexico
growth rate for this month is 48.5 per cent against have recorded a growth of 12.6, 30 and 21.4 per
the exports in March 2020 (USD 1.54 billion)," Udaya cent respec vely.
Bhaskar, Director General of Pharmexcil said in a
release. South Africa being the second largest expor ng
country, recorded a big jump of 28 per cent growth
Growth rate seems rela vely big as the exports of while Europe was the third largest expor ng region
March 2020 was crunched due to lockdown across which has recorded approximately 11 per cent
the world and supply chain disrup on, he was growth over previous year.
quoted as saying.
Growth of Country wise exports
When the global pharma market is nega vely grown
by 1-2 per cent in 2020, there is a big surge in US 12.6
demand for Indian made generics owing to its Canada 30
quality and affordability, the official said adding Drug Mexico 21.4
formula ons and Biologicals is the second largest
Principal commodity being exported by India. Source: Business Standard
The Pharma exports body is expec ng big growth in
Indian vaccine exports in the coming years and the
government policy on PLI (produc on Linked
Incen ve) scheme will also help the domes c
pharma to grow by reducing import dependence
and develop export poten al in the days to come as
most of the countries are looking at India for APIs (
ac ve pharmaceu cal ingredient) he said.
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NEWS FIP CEO receives Nagai International
Woman Scientist Award
We're proud to share news that our CEO Pharmacy, University of No ngham. She has been
Catherine Duggan is the recipient of awarded Fellowships of both the RPS and the UCL
the Academy of Pharmaceu cal School of Pharmacy and is a Fellow of the Royal
Science and Technology, Japan (APSTJ) Nagai Society of Arts.
Interna onal Woman Scien st Award. The award is
being made during the 36th annual mee ng of the Un l April 2018, Dr Catherine Duggan was the
APSTJ, which began today. Director of Professional Development at the Royal
Pharmaceu cal Society of Great Britain, where she
“The importance of pharmaceu cal science in all was responsible for the delivery of professional
walks of life has never been more apparent as during advice and support to all members across all
the COVID-19 pandemic, where, because of sectors; the development of strategies to share and
endeavour and collabora on in all walks of science - showcase good prac ce across the profession and
pharmaceu cal science most notably - we have development and implementa on of professional
managed to repurpose treatments, develop tests standards for pharmacy. From 2012, Catherine led
and develop new technologies and vaccines for a the development, implementa on and strategic
novel virus in the shortest me period ever,” embedding of RPS Faculty and Founda on
Dr Duggan said in her award acceptance speech. programmes into con nuing professional
development.
The Nagai Founda on, established in 1986, is a not-
profit organiza on that promotes interna onal Source: Interna onal Pharmaceu cal Federa on
exchange in pharmacy and pharmaceu cal sciences. (FIP)
Dr Catherine Duggan is the Chief Execu ve Officer of
the Interna onal Pharmaceu cal Federa on. She
took up the role in The Hague in June 2018.
Catherine is responsible for visionary leadership,
support, development and advocacy across the 144
member organisa ons and the four million
members FIP represents. She is responsible for
developing and delivery the strategy, planning and
working across global organisa ons such as WHO
and UN, and other interna onal professional
groups. Catherine will chair the World Professions
Health Alliance which represents 31 million health
professionals across medicine, nursing, den stry,
physiotherapy and pharmacy.
Upon taking up the role, Catherine was awarded an
honorary Professorship from the School of
60 PHARMA PRO & PACK | APRIL - JUNE 2021 www.ipmma.org
ADVERTISERS’ INDEX
Name of the Company Page No. Name of the Company Page No.
Arbes Tools Pvt. Ltd. 43 Mark Maker Engineering Pvt. Ltd 47
Accupack Engineering Pvt. Ltd. 1 N.K.P. Pharma Pvt. Ltd. 25
Allegro Pharmachem Equipments 5 Neelkamal Agency Pvt. Ltd. 55
Allied 39 Osworld Scen fic Equipments Pvt Ltd 11
Ami Polymer Pvt. Ltd. Back Cover Parle Global Technologies Pvt Ltd Front Inside Cover
B&R Industrial Automa on Pvt. Ltd. 13 PCI Analy cs Pvt.Ltd. 64
Beckhoff Automa on Pvt. Ltd. 32 & 33 Prism Pharma Machinery 29
Big Logis cs India Pvt. Ltd. 59 Promas Engineers Pvt. Ltd. 45
Brothers Pharmamach (India) Pvt. Ltd. 27 RPFM Technologies 49
Concept Engg. Co. 9 S. K. Pharma Machinery P Ltd. Back Inside Cover
Electrolab India Pvt. Ltd. 35 Tapasya Engineering Works Ltd 53
Elmach Packages (India) Pvt. Ltd. Gate Fold Techline Industries 17
Fabtech Technologies Interna onal Ltd. 31 Technofour Electronics Pvt. Ltd 23
Gla (India) Engineering Pvt. Ltd. 51 Vaxom Packaging Pvt. Ltd. 3
Integrated Cleanroom Technologies Ltd 21 Vijay Engineering Corpora on 39
Kothari Pharma Technologies Private Ltd 19 Worldpack Automa on Systems Pvt. Ltd. 15
Maharshi Udyog 37
IPMMA SERVICES
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PharmaEdge:
More than just SCADA
The pharmaceu cal industry is facing PharmaEdge is a unique solu on that offers all benefits of SCADA and
unprecedented challenges with an a robust control system in one device. It is an industry 4.0 ready
increase in regulatory compliances. On top solu on with possibili es of energy monitoring, condi on-based
of that, the complexity of regulatory compliances maintenance, predic ve maintenance, MES / ERP connec vity,
has increased substan ally over recent years, repor ng, and advanced analy cs.
and it is expected to grow further soon.
Advanced automa on technologies have For more details, please visit: h ps://www.br-automa on.com/en-
become an essen al part of pharmaceu cal in/service/pharmaedge-more-than-just-scada/
processes. From lowering produc on costs to
simplifying data collec on, compliance, and
management between various machines, lines,
plants, and processes, automa on solu ons
have ensured consistent product quality, flexible
produc on, along with solid adherence to ever-
changing regulatory compliances.
B&R's PharmaEdge is an integrated, out-of-the-
box, op mized offering for the pharma industry
to meet increasing demands of FDA compliance.
It helps to achieve advanced func onality of
detailed repor ng, analy cs, and business
intelligence while ensuring top-class cyber
security.
Xplanar: Flying Motion
Beckhoff is opening up new avenues in machine design provided by the TwinCAT automa on so ware.
with XPlanar. For machine builders this results in
maximum flexibility and simplifica on in the design of Xplanar is suitable for use as a highly flexible
machines and plants. transport system in general machine building,
especially for the automa on of packaging, assembly,
The XPlanar system combines the planar les and the planar sor ng and order picking processes. The free choice
movers floa ng above them. The movers can be moved jerk-free of surfaces – easy-to-clean glass, stainless steel in
and contact-free in two dimensions at speeds up to 4 m/s with 2 g hygienic design or plas c film – enables the use in the
accelera on and 50 µm posi oning repeatability – and clean room, and in the pharmaceu cal and food
noiselessly and without abrasion at that. The contact-free mover
travel also eliminates wear, emissions, and the carryover of
contamina ons because it is fric onless.
Flexible and versa le mo on func ons
The planar les, which measure 240 x 240 mm can be arranged in
any desired geometries that are precisely adapted to the
applica on at hand. The les contain the en re electronics and
uses EtherCAT G communica on. The planar movers with
integrated permanent magnets that float above them.
The collision-free and synchronized movement of several
movers with automa c path op miza on are further features
62
Carton Bundling & Stretch
Banding Machine STR 400
With the endeavour to STR 400 is suitable to handle a wide size range of cartons containing all Pharma
provide effec ve & efficient products like Blisters, Bo les, Tubes, and Vials. The Track and Trace 2D codes
end of line solu on a er are clearly visible on the carton for further automa on process of Track and
Cartoning for the Pharma industry, Trace Aggrega on. STR 400 can replace Shrink wrapping as the product is not
Khimsaria Associates Pvt. Ltd. has exposed to high temperatures and there is dras c reduc on in consump on of
developed automa c Carton Bundling & film.
Stretch Banding machine STR 400 in
collabora on with a Design house based To know more about STR 400, please do write to us at [email protected] /
in Italy. The machine has a Balcony [email protected]
design with a compact footprint and
contains Servo drives for carton
colla on, carton pushing, and band
sealing opera ons.
STR 400 stacks cartons in a required
matrix to form larger units and then
ghtly wraps them in LDPE film. STR 400
can be integrated with high speed lines
with infeed speed upto 300
cartons/minute delivering output upto
30 bundles/minute depending on the
carton size, bundle size, and bundle
matrix.
A complete Docking Bay Technocrat
includes the Dock Leveller, Sectional Overhead Door & the Inflatable
Dock Shelter, thereby providing a complete Docking Bay Solution.
These products make the loading-
unloading process quick and neat also
with physical manpower being a
challenge these days these Docking Bays
would be a boon to companies like
Pharma/Auto/Logis cs/ etc.
In a docking bay, one problem to overcome is
the problem of bridging the gap between a
truck and the dock or warehouse floor. Not all
trucks are the same height, and the height of
the trailer floor within a truck can vary
according to how heavily the truck is laden.
Thus, there is not only a gap to bridge but a
height difference to overcome.
63
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