IPMMA Magazine - October December 2021

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TECHNOLOGY Maintenance Spare Strategy Reliability Strategy Example
Strategy
Low Low Complete None Bench top
Low Run to fail quali ed spare analy cal
Med OEM equipment
recommenda ons Stock PM and Basic KPI
High OEM cri cal spares (Down me) Simple,
High High recommenda ons based on OEM well-understood
with op miza ons u li es
Stock PM and Basic KPI, some
FMEA cri cal spares condi on-based Basic
RCM enhanced based on OEM. maintenance manufacturing
training Addi onal spares unit opera ons,
determined by like HVAC
assets and history
in cross-func onal Complex
review manufacturing
unit opera ons,
Based on output Advanced KPIs, mul stage u li es
of FMEA condi on-based
maintenance

Based on RCM Advanced KPIs, Unknown
condi on-based technologies
maintenance,
perspec ve
analy cs

efforts on the systems that will have the most 2. Cri cali es, and subsequently, maintenance
significant impact on your business. Cri cality strategies, can change over me and should be
evalua on is a rela vely simple exercise that may reviewed periodically.
consume a few hours to as much as a week to
complete. S ll, our experience is that many clients 3. Failure Mode and Effect Analysis (FMEA) /
have not completed it. At the conclusion, you can Reliability Cantered Maintenance (RCM)
stra fy your assets into buckets. We recommend ac vi es should be conducted with a cross-
five because they will match with the designated func onal team, and the vendor should be
maintenance strategy. present. These ac vi es appear to be high
upfront costs for the organiza on, but the
As stated previously, your maintenance strategy financial impact of their failures can be much
would be based on a ruleset. For our purposes, we'll higher further down the road.
use the five layers of the cri cality evalua on and
assign each to a strategy. During the start-up phase of a site or project, your
organiza on may choose to strictly implement OEM
A few notes on the execu on of these maintenance recommenda ons for reasons such as schedule,
strategies: cost, or lack of experience with the equipment. This
is a common strategy we see with many clients, so
1. When selec ng Run-to-Fail, it is s ll incredibly what can the organiza on do during the start-up
important to have a plan such as a complete phase to allow for con nuous improvement later?
spare or parts required for maintenance on All of these items are engineering best prac ces
hand in the event of failure. that many clients overlook and, unfortunately, pay
the price for later.

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TECHNOLOGY 1. Conduct your asset cri cality evalua on in the metrics and analy cal tools makes your
beginning. It is a rela vely simple exercise and reliability engineers' efforts genuinely
will guide the organiza on when future effec ve. These codes can be basic in the
op miza on is needed. beginning and get more specific as the
organiza on learns more.
2. Write work orders to the lowest effec ve level.
Many clients write work orders to the system As this ar cle shows, simply following OEM
level, which requires a tremendous amount of recommenda ons for maintenance can result in
data diving later. Breaking Computerised the assets not mee ng expecta ons. The primary
Maintenance Management Systems (CMMS) driver of these failures is due to the disconnect
master data to lower levels, in the beginning, between the OEMs design and the opera onal
will save tens of thousands of hours and context. A formal approach to risk-based
frustra on later. maintenance strategy can focus your organiza on's
resources to tackle those areas where the
3. Define breakdown work orders vs. repair. disconnect is likely more pronounced. The
Providing this degree of severity for the impact maintenance strategies contained here will guide
of maintenance work allows your future the organiza on in developing the various
engineers to focus their efforts on the most maintenance methods, spare parts requirements,
cri cal. and reliability approach. Finally, if the organiza on
chooses the OEM strategy approach, there are vital
4. Well documented work order notes. First, it is a prac ces you can implement to enable con nuous
regulatory expecta on that work order notes improvement in the future.
be complete and stand-alone, but also become
crucial when op mizing opera ons and Source: Nick Armstrong, Global Director, Asset
maintenance. Management & Reliability - cagents

5. Failure Codes. This is probably the most
overlooked efficiency gain by most clients.
Categorizing the failure, cause, and ac on of
repair or breakdown work using building

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TECHNOLOGY Decentralised manufacturing:

how outsourcing is helping to bring the personalised
medicine promise to reality

Personalised medicine represents a revolu on in healthcare strategies. Combining tradi onal clinical
informa on with gene c data delivers a highly targeted treatment to either a stra fied pa ent cohort
or individual pa ents based on specific ssues and gene therapies, as well as the DNA of the disease.

With the global personalised medicine regulated environment.
market set to be valued at $2450 billion
by 2022, and with more than a third Shi ing to a decentralised model can increase the
(35%) of FDA-approved drugs for cancer being efficiency of manufacturing and delivery, and offers
defined as personalised medicines, this trend brings a prac cal solu on for personalised medicine
new commercial challenges to the fore, reports produc on. The result is that pharmaceu cal
Sepha's Business Development Manager Sco organisa ons are increasingly seeking to outsource
Kenny¹ ². ac vity to specialists.

Introducing personalised medicine calls for flexible Why is decentralised manufacturing a promising
manufacturing processes, par cularly if the goal is, op on?
one day, to produce a “batch of one.”³.
The future of personalised drug manufacturing
Personalised medicines cannot be brought to lends itself to a decentralised model, par cularly in
market without new, highly agile packaging the fast growth sector of Cell and Gene Therapy
solu ons. Packaging requirements are growing in (CGT). Manufacturing capacity must be able to suit
complexity to accommodate sensi ve formula ons, pa ent-specific therapies that can sa sfy the
fast turnaround mes and smaller batches. eventual demand.

To fill and pack personalised medicines, packaging This is primarily because of the short shelf-life of
systems need to be able to handle small batch sizes these products and the limited op ons for storage
reliably, quickly and safely, all while maintaining and shipping - par cularly within the cold chain, a
product integrity. cri cal factor highlighted recently by the supply and
distribu on issues surrounding the COVID-19
What's more, this small batch packaging depends on vaccine.
flexibility throughout the produc on process.4 For
this reason, the concept of decentralised “For this reason, when me-to-customer is key,
manufacturing, in which produc on is managed at long-distance transit is undesirable and, in many
local level for responsive product delivery cases, simply does not present a viable op on.
customised to the end user, offers an a rac ve
solu on to overcome the challenges facing the Furthermore, products that require a late-stage
supply chain.

Large pharmaceu cal manufacturers and Contract
Manufacturing Organisa ons (CMOs) might not
always be best placed to accommodate low volume,
small run packaging. Equally, smaller companies
rarely have the infrastructure, resources or
exper se in place to handle small batch runs,
par cularly for high potency drugs, in a complex

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TECHNOLOGY customisa on, such as bioprin ng, are par cularly stability tes ng is important.
suited to being manufactured close to a clinical
se ng. A decentralised network allows Regula on requires expira on dates to be displayed
manufacturing to be sited in close proximity to on all pharmaceu cal products. The US Food and
treatment centres. Drug Administra on (FDA)'s Good Manufacturing
Prac ce for Finished Pharmaceu cals established
Outsourcing to the experts: a cri cal success factor requirements concerning the expira on date on a
in personalised medicine drug product and stability tes ng to ensure the
appropriateness of that date¹⁰.
Accoun ng for individual variability in genes,
environment and lifestyle requires a sea change Furthermore, each drug will be unique because of
from mass produc on to small-scale, individualised differences in chemical and physical proper es of
manufacturing. the ac ve ingredients or excipients, manufacturing
processes, formula ons, containers/closures and
This change depends on the technology revolu on storage, and will also harness unique characteris cs
of Industry 4.0 and includes next-genera on based on each individual's gene c make-up¹⁰.
manufacturing, big data, smart networks and the
Internet of Things (IoT) to create an interconnected “Stability also depends on the proper es of the
value chain configured to operate autonomously. drug itself to maintain its quality and purity through
the use of an oxidants or preserva ves. The
In the future, we are likely to see a decentralised product's packaging plays a key role here.
model based on localised produc on “nodes” rather
than a single large-scale manufacturing facility. This Stability studies are important to test the packaging
is when outsourcing becomes key to success. suitability for regulatory approval and also for new
drugs when material selec on can also be a
In pharmaceu cal drug development, the challenge.
outsourcing model is already well established. This
next logical step will follow, wherein major An expertly managed stability study will measure
pharmaceu cal manufacturers will rely on a series the effects of varia on in temperature, me,
of experts in their respec ve fields to set up humidity, light and par al vapour pressure on the
localised nodes. These third-party contractors will drug. In personalised medicine produc on, when
take on a key role as partner in the area where they shelf-life is short, it is cri cal to get the packaging
already offer exper se. right.

Stability tes ng Drug developers depend on the flexibility and
speed of their packaging supplier to accommodate
Because Compe ve Gene c Therapy (CGT) complex and varied stability studies. Non-
products are extremely sensi ve to uncontrolled destruc ve leak tes ng, for example, maximises
varia ons in the distribu on chain, such as produc on efficiencies while maintaining the
temperature, me and humidity, measures must be integrity of the product.
taken to provide robust quality control during
manufacture and shipping. Avoiding cross-contamina on of highly potent
drugs
As a “living drug”, CGTs remain effec vely in culture
during transport and require ac ve management of In small batch produc on, pharmaceu cal
the product⁹. manufacturers must frequently switch between
batches. This places high importance on process
These specialist, high potency drugs need dedicated safety and efficiency to avoid cross-contamina on
packaging that does not fail or compromise on the and ensure occupa on safety.
quality of the drug. For this reason, packaging

54 PHARMA PRO&PACK | OCTOBER - DECEMBER 2021 www.ipmma.org

Outsourcing to experts, who have the necessary lab to grow in a future that brings personalised TECHNOLOGY
and clean room classifica ons in place, is medicine to reality.
par cularly important in the high potency drug
produc on sector that characterises the With advanced CGT a rac ng new collabora ons
personalised medicine market. and significant funding, typified by the UK Catapult
model, and with digital transforma on poised to
Specialist manufacturers will ensure that fully deliver the automa on, predic ve data analy cs
compliant processes are in place to protect both the and collabora on tools needed to support the
drug and the operators. development of personalised medicine, drug
manufacturers need to look to partner with
Personalised medicines are o en supplied in companies who can help bring the vision to
prefills, such as syringes or other medical devices prac cal applica on.¹¹
that are designed to be self-administered. These
sensi ve products, par cularly in the case of References
biological medicines, need to be packaged in stable
temperature and humidity condi ons. Specialist 1.h ps://healthmanagement.org/c/hospital/issue
contract packaging companies can advise on the ar cle/top-target-treatments-infographic.
most effec ve and cost-efficient solu ons to
op mise packaging. 2.www.bluela tude.com/how-we-
think/mastering-the-precision-medicine-
Avoiding over-specifica on of materials is opportunity.
important, as personalised medicines are produced
in short runs for rapid delivery, so do not need the 3.www.healthcarepackaging.com/markets/pharm
longer shelf-life requirements of more stable drugs. aceu cal/news/13284409/personalized-
medicine-a-batch-of-one.
Working with specialists ensures efficient and
integral pack design to best suit the product. For 4.h ps://packagingeurope.com/personalised-
example, blister packs provide product security for medicine-imposes-increasingly-complex-
high potency, high sensi vity drugs through the requireme.
protec ve barrier of individually packaged tablets.
5.www.sciencedirect.com/science/ar cle/pii/S146
Most blister packs, however, are currently mass 5324918305140.
produced on high speed form, fill and seal
machines. Experts in this field can provide materials 6.www.sps.nhs.uk/ar cles/maintaining-the-covid-
advice and help with a variety of pharmaceu cal 19-vaccines-cold-chain.
blistering materials that house the product
correctly. Specialists in this field can also offer 7.N. Medcalf, “Centralized or Decentralized
opera onal advantages, such as working under Manufacturing? Key Business Model
modified atmospheric condi ons to safeguard Considera ons for Cell Therapies,” Cell Gene
product integrity during the packaging process. Ther. Insights 2, 95-109 (2016).

In the future landscape as personalised medicine 8.www.sciencedirect.com/science/ar cle/abs/pii/
becomes more common, specialist small batch S1748681517302358.
packaging suppliers with a strong track record in
compliant drug packaging and the agility to produce 9.www.sciencedirect.com/science/ar cle/pii/S146
batches as small as one will become a key part of the 5324918305140.
supply chain.
10.www.fda.gov/inspec ons-compliance-
Conclusion enforcement-and-criminal-
inves ga ons/inspec on-technical-
The pharmaceu cal outsourcing model is only set guides/expira on-da ng-and-stability-tes ng-
human-drug-products.

11.h ps://ct.catapult.org.uk/news-
media/general-news/advanced-therapy-
treatment-centre-network-awarded-
%C2%A395m-further-investment.

Source: Manufacturing Chemist, July 26, 2021

www.ipmma.org PHARMA PRO&PACK | OCTOBER - DECEMBER 2021 55

BEST PRACTICES Best Practices for Effective Quality
Documentation Processes in Drug
Manufacturing

Introduc on No two organiza ons are alike, so no two quality
documenta on processes are the same but all
Drug development has gone through a lot of successful systems have key elements in common.
changes over the past decade. A prac ce These nine elements are best prac ces, based on
once dominated by pen-and-paper has modern research and a century of trial and
since transi oned to computerized systems, cloud error, that organiza ons can follow to build a
so ware, and ar ficial intelligence. There is always a comprehensive document management process
balance between speed and compliance, while that balances the internal and external needs for
others struggle to adopt new technologies because things like efficiency, integrity, and compliance.
of the uncertainty of how to comply with FDA
regula ons. Needless to say, developing a quality 1. Tailored for the Way you Work
and compliance posture that meets the needs of
both masters (business stakeholders and auditors) is A modern quality documenta on process is
a tall order. In this piece, we will chronicle the trends worthless if it can't adapt to the way modern
that successful Quality & Compliance teams adopt workforces interact. Today's teams are distributed,
to keep pace with the speed of discovery. and a lot of work is performed outside normal
business hours and outside normal office
“If it's not documented, it didn't happen” environments. Your process must accommodate
“the new normal” and accommodate any file,
This is a well-known saying by Quality teams in whether it is Microso Office or Google Docs.
biotechnology. What it means is that every step in
the development, clinical, and manufacturing 2. Change Control and Revisions
processes needs to be documented or else
regulators can't accept that it happened. In the eyes “The only constant is change.” When it is necessary
of the FDA, without documenta on, the research, to make changes to regulated documents, it is vital
the clinical trials, or the manufacturing process that these changes go through the same scru ny as
needs to be repeated. This results in added expense, the crea on of the document. Efficiency and control
costly delays, and an erosion in trust from must be balanced so being able to review who was
regulators, investors, and consumers. involved in the crea on of the document and what
they contributed is key to making sure the changes
Reasons for upda ng document management are properly ve ed.
process:
3. Managing the Complete Lifecycle of Documents
l Bo lenecks, inefficiencies, and capabili es
l User frustra on Promo on of documents from Dra to Effec ve
l Lack of visibility status, or the re rement from Effec ve to Obsolete
l Complex and inconsistent are important to ensure that there is an explicit,
authorita ve collec on of current quality
processes documenta on. Changes should never be made to
l Not mee ng regulatory Effec ve or Obsolete versions for audi ng purposes.
Scheduling a document's end-of-life no fica on or
requirements a periodic review is a good policy for making sure
l Cost and me savings documents are up to date and usable.

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BEST PRACTICES 4. Classifica on, Organiza on, and Repor ng documents don't make their way to those who need
to see them. Training ensures that effec ve
Classifica on of quality documenta on can be sliced documents are presented and signed off by
a number of ways from who can access documents designated employees and external partners.
to who owns the changes to dates of effec veness. Automated no fica ons and past-due reminders
Metadata, or informa on about the document, prompt ac on and mi gate risk.
should be stored and accessible for search or
repor ng purposes. Because every company does 9. Secure Access and Data Security
things a li le differently, the ability to customize
metadata fields to your specific use case is Circling back to how the modern workforce
immensely helpful. operates, it is no longer face to face. Team members
work from home or other offices, Some work for
5. Lock Down Effec ve Documents different companies in other countries. Keeping
that data secure, private and compliant is more
Once a file is effec ve, it's best prac ce to make sure difficult than ever. A modern quality document
the file can't be altered. Saving as a PDF is a generally management system needs to provide:
accepted way of providing a locked version of the
document that can't be modified by end users. A l Privacy (GDPR/CCPA) Compliance
signature page (in compliance with 21 CFR Part 11 l Secure but easy sharing of data
requirements) will show the last date of change and l Encryp on of data in transit and at rest
the name of the person(s) who approved the l Monitoring of suspicious behaviour on the
document.
system
6. Review and Approval Workflows l Protec on against cyber-a acks and

Workflows need to accommodate different kinds of ransomware
documents. The process for approving an SOP will
be different and require a different number Takeaway
of par cipants than the transla on of a job
descrip on. A modern quality documenta on Compliance and con nual improvement rely on a
process will accommodate simple to very complex robust quality management system. That system is
workflows and will allow for internal and external made up of people, process and technology. An
partner par cipa on. imbalance of any one of these three key pillars can
cause the other two to be ineffec ve. Choosing the
7. Integrated Repor ng Capabili es right technology to support your people
and process will ensure a quality document
The ability to be able to report on and derive insight management system that enables compliance and
out of a quality document management system is mi gates risk, quickly demonstra ng value.
important for internal and external stakeholders. A
centralized repor ng module helps reduce the For many companies in the life sciences industry,
administra ve burden of tracking down compliance compliance is a mission-cri cal requirement.
issues. Whether you are repor ng on employee Egnyte makes it easy to meet the requirements
training or providing access for external auditors, highlighted in Part 11 and Annex 11, USFDA for
robust repor ng capabili es need to provide status computerized systems. Egnyte for Life Sciences
on Document Adop on, Document Lifecycle Events, enables companies to rapidly create a compliant
Audit Trails and Metadata/Classifica on. repository, validate it, and use it for their regulated
data - with be er collabora on, compliance, and
8. Training control over your most valuable asset, your data.

The best quality systems don't mean a thing if the Source: Pharmaceu cal Online Newsle er (August
30, 2021) by Alok Tayi, Ph.D, Egnyte.

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BEST PRACTICES The Hidden Cost of Inefcient
Laboratory Practices

This ar cle presents an risk of basic human errors or uninten onal
overview of the main oversight, requiring scien sts to repeat
inventory management experiments unnecessarily.
challenges faced by fast-paced
biotech and pharmaceu cal Finally, if these errors get overlooked, again, due to
laboratories, highligh ng how this the heavy reliance on manual checks, it can result in
directly impacts research cascading inaccuracies within the en re research
outcomes, costs and regulatory project, impac ng data reproducibility and delaying
compliance project melines.

Unproduc ve Time: How Without streamlined or digital methods to manage
Everyday Inefficiencies Impact inventory, scien sts also face mul ple reagent-
Research Output related obstacles during a working day. For instance,
commonly used reagents might become misplaced
If scien sts were to closely as they are used by different laboratory staff.
examine their daily ac vi es, Without a system to monitor inventory, it can be
everyday inventory management would account for challenging to track down these reagents or obtain
a sizable chunk of total me spent. an overview of the stock. As a result, mul ple
bo les are o en opened at once, causing resource
Our survey reveals that rou ne inventory upkeep in mismanagement and unnecessary wastage. To
laboratories consumes up to 25% of a scien st's corroborate this problem numerically, 60% of the
scien sts we surveyed said they have some form of
me. In a series of repe ve manual tasks, scien sts tool in place to manage inventory, but 90% of them
document each arriving reagent, record its details, s ll struggled to find the loca on of consumables.
mark opening dates and track expiry. They then
need to inspect records of mul ple reagents they've The challenge for R&D leaders
handled and manage their inventory before and
a er use. Any transcrip on errors made at the Laboratory managers and R&D leaders, who may
manual inventory registra on step remain in the
archives and trickle into the rest of the workflow,
threatening data integrity.

The challenge for Scien sts

Manual inventory management prac ces make it
rather cumbersome for scien sts to carry out daily
responsibili es. Firstly, scien sts need to perform

25% of a scien st's me is spent
on rou ne inventory upkeep.

the laborious and me-consuming process of
manually entering inventory records, some mes
mid-experiment. These manual tasks o en face the

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BEST PRACTICES not be privy to the day-to- day challenges faced by performing tedious data entry tasks. The risks of
scien sts, o en no ce that workflows tend to take higher employee turnover due to professional
much longer than expected, but rarely an cipate dissa sfac on not only stretches project melines
inventory mismanagement as the root cause. Their but also diminishes the morale of exis ng staff.
monthly checks reveal too many expired reagents or
Mo on waste: When informa on is all over the
52% of researchers acknowledge place
discarding unused or
expired stock Maintaining and loca ng manual inventory records
can aggravate inconveniences on a daily basis. Every
a sudden reagent shortage despite having an
inventory system in place, unaware that the system me a reagent is required, scien sts need to
is unreliable and inconvenient to use. Moreover, to physically scour through storage cabinets to find it,
perform these root-cause analyses, they invest increasing the me spent on low-value tasks. Once
more me and resources to comb through all the the reagent is located, its relevant details for
manual data that is error-prone to begin with, experimental records will again require flipping
discovering isolated data silos or data graves,
some mes with irretrievable informa on. 90% of scien sts struggle to
find the storage loca on of
consumable, even with some

sort of tool in place

The challenge for C-suite leaders through archived files. Repe ve ac ons to locate,
use, record and suitably store reagents amount to
CEOs in the biotech and pharmaceu cal industry significant mo on waste in a laboratory.
seek to improve opera ons, expand the company's
capabili es and reshape its talent. In their efforts to Mo on waste may seem rather innocuous, but in
maintain data integrity - the very essence of the closer analysis, it o en results in a two-pronged
company's opera ons - they may not fully recognize a ack on the laboratory's overall research output:
that best data management prac ces are not
en rely a ainable with just manual methods. If l The unreasonable costs of having highly trained
there's a digital system in place, C-suite leaders tend scien sts performing low-value tasks every day.
to assume that it is being used, when in reality, their
scien sts may either find these systems too l The lost value to the research project as capable
complicated or simply a hindrance to their long to- laboratory personnel is obligated to priori ze
mundane inventory management over high-
€10.2Bn costs the value contribu ons.
EU economy every
year due to improper Cumula ve effects of unproduc ve me spent by
data management every scien st across mul ple departments or sites
can nega vely impact business outcomes. This
do list. When C-level execu ves create budget plans could mean losing compe ve advantage in the
to reduce costs and manage resources more pharmaceu cal industry due to extended
efficiently, they may totally disregard the costs
associated with the unproduc ve me spent by me-to-market. Similarly, in Contract Research
highly skilled laboratory personnel in carrying out Organiza ons (CROs), mo on waste can gradually
repe ve, mundane inventory tasks. Finally, in diminish business poten al with slower project
managing the company's R&D talent, C-suite turnarounds limi ng the number of clients served.
leaders may be completely blindsided by the When accoun ng for laboratory costs, inventory
overwhelm experienced by their scien fic staff in management and mo on waste are generally not
considered as contribu ng factors. However, a

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BEST PRACTICES report released by the EU Commission es mated other's record-keeping systems. In fact, in a recent
that improper data management in research case study, we found that researchers in a
ac vi es costs the European economy at least pharmaceu cal company spent up to 50 minutes to
€10.2 billion every year. Outlining best prac ces, find a sample. When scaled over thousands of
the report suggests that research data needs to be employees, such unproduc ve me can
FAIR: Findable, Accessible, Interoperable, and significantly impact the company's capabili es.
Reusable.
To address mo on waste, R&D leaders will need to
This me-sink caused by everyday mo on waste start probing into how their scien fically trained
directly impacts data findability. Plus, the lack of a team members end up spending me on repe ve,
reliable system makes it difficult to access records mundane inventory-tracking tasks. In the long run,
for annual stock reviews or audits. During instances career fulfilment for a scien st comes from solving
of data interven on by either a regulatory authority
or a laboratory manager, addi onal me is then 50 Min spent by the researcher
spent on re-capturing old data records into more to find a sample in
preferred formats. Frequent episodes of data the laboratory
cleansing can result in substan al mo on waste as
scien sts pause research projects to instead get bigger research ques ons. Without a prompt
inventory records in order. resolu on, these ineffec ve laboratory prac ces
can translate into lower professional sa sfac on,
Data entry inconsistencies coupled with poor data under performance or higher employee turnover.
governance in a laboratory can further increase
mo on waste as team members decipher each

Quick steps to prevent mo on waste

Make it easy to capture

A quick and error-free digital data capture system can give scien sts their me back. Our survey
revealed that incorpora ng an inventory management system reduces the annual me required to
manage inventory by 97%.

Make it easy to find and retrieve

Having a centralized inventory dashboard where laboratory members can view stock records in real-
me can minimize search me.

Easy workflow adop on

The inventory management system needs to be simple to use and easily integrated into exis ng
workflows without requiring elaborate training or IT set-up.

Source: This is the abridged version of the original whitepaper by Merck KGaA, Darmstadt, Germany.
(Visit the link for the whitepaper h ps://lanexosystem.com/hidden-cost-of-inefficient-laboratory-prac ces)

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QUALITY Efciency for Validation

- Continuous Change and Improvement

“Risk-based approaches for improving associated systems (i.e., u li es, facili es, and
valida on compliance and efficiency” equipment) is one of the major cGMP
requirements. Valida on is meant to demonstrate
Overview that the processes and associated systems work
properly and their results are reproducible.
The U.S. Food and Drug Administra on (FDA) Valida on is not a one- me event. It con nues
defines valida on as establishing documented through the en re life cycle of a system or processes
evidence which provides a high degree of assurance and provides ongoing assurance that a process
that a process sequence consistently produces a remains in a state of control during rou ne
product mee ng pre-determined specifica ons and produc on, through quality procedures and
quality a ributes. Tradi onally, the execu on and con nuous improvement ini a ves. All valida on
documenta on of valida on is extremely me- documenta on is reviewed during regulatory
consuming. The efficiency and compliance of the agency pre-approval inspec ons. Evidence of
valida on process can be greatly enhanced by using successful valida on is a requirement for the
pre-approved forms and master protocols. approval of a pharmaceu cal product for
Implemen ng risk-based approaches to set commercial sale.

re-valida on me intervals and determine which Valida on strategy and life cycle
valida on ac vi es to perform are also helpful
The use of a risk-based approach to valida on based
Why is valida on important? on ASTM E2500, “Standard Guide for Specifica on,
Design and Verifica on of Pharmaceu cal and
Valida on of the manufacturing process along with Biopharmaceu cal Manufacturing Systems and

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QUALITY Equipment,” [1] has become the industry norm. Once the system is in GMP opera on, changes are
Applica on of the approach it describes is intended governed by the change control process and
to sa sfy interna onal regulatory requirements by periodic reviews are performed to assure
ensuring manufacturing systems and equipment are cumula ve changes do not impact the validated
fit for intended use and to sa sfy qualifica on state. This ensures all changes are assessed for their
requirements for design, installa on, opera on, and impact on the previous valida on and for the need
performance. The approach applies concepts and for re-valida on. Some processes, such as steam
principles introduced in the FDA's “Pharmaceu cal steriliza on, require re-valida on on an annual
cGMPs for the 21st Century - A Risk-Based basis. Calibra on and preven ve maintenance are
Approach” [2] ini a ve, which is consistent with the performed at scheduled intervals, and u li es and
framework described in ICH Q8 [3], ICH Q9 [4], ICH classified environments are monitored on an
Q10 [5], and ICH Q11 [6]; and is designed to conform ongoing basis to verify a state of control.
with FDA, EU, and other interna onal regula ons
regarding equipment and facility suitability for use How can valida on be more efficient?
and qualifica on.
One way to improve the efficiency of valida on is to
The valida on process begins with the streamline the documenta on process and
determina on of user requirements - specifica ons minimize redundancy. Tradi onally, paper-based
that define the business processes and func onality protocols are prepared for each valida on step for
to be provided by the system. The next steps are to each system, then each document is routed
perform a quality risk assessment and, where there sequen ally for review and approval. With paper
is risk, develop a strategy for elimina ng or reducing documents, protocols for similar systems may be
risk to an acceptable level through design control inconsistent, sequen al review and approval can be
and/or procedures. Following that is the lengthy, and the documents are o en misplaced or
development of design specifica ons to describe lost. Implemen ng master protocols and pre-
the integra on of user requirements and design approved forms can significantly increase
controls. Then it goes on to verifica on tes ng, consistency and efficiency in the documenta on
which includes Factory Acceptance Tes ng (FAT), process.
Site Acceptance Tes ng (SAT), Commissioning,
Installa on and Opera onal Qualifica on (IOQ), and For example, if several freezers, autoclaves,
Performance Verifica on (PV). bioreactors, or other common equipment are being
installed at the same me, master protocols and
Historically, each verifica on test has been pre-approved forms would ensure consistency and
performed individually, off site, by the equipment all the similar equipment could be validated at the
manufacturer. Once the equipment is on site, the same me, without rou ng each set of valida on
FAT and SAT are first performed separately, then documents separately. This approach also would be
repeated as part of the IOQ. However, in recent useful for systems that require annual re-valida on
years, this is o en streamlined by not repea ng - the use of a pre-approved master protocol would
verifica on tes ng as part of the IOQ. eliminate the need to prepare and approve all
documenta on annually for each system. Likewise,
Once verifica on tes ng is complete, the final step is using pre-approved forms that are ready to print
to summarize the valida on tes ng in an acceptance and execute to record valida on tes ng results
and release report, which provides a summary of would mean numerous systems could be
the tes ng performed, the test results, a traceability validated without the need to approve tes ng
matrix illustra ng how each user requirement was documenta on separately for each valida on.
tested, and, if the user requirements were met and Furthermore, addi onal efficiency can be gained by
valida on was successful, a release statement using a validated electronic system for the
indica ng the system is acceptable for use. prepara on, review, and approval of master

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QUALITY protocols and forms, and the en re process could “ Valida on is meant to demonstrate
be completely paperless if tablets or laptops are that the processes and associated
used to record the valida on tes ng. systems work properly and their
results are reproducible. Valida on
Another way to improve the efficiency of valida on is not a one- me event. It con nues
is to implement risk-based approaches to se ng re- through the en re life cycle of a
valida on me intervals and determining which system or processes and provides
valida on ac vi es to perform. ongoing assurance that a process
remains in a state of control during
For example: rou ne produc on, through
quality procedures and con nuous
l For controlled temperature unit valida on, a improvement ini a ves.
risk analysis can be performed to jus fy
performing re-valida on less frequently - or not Interna onal, West Conshohocken, PA, 2020,
at all, if the systems are connected to a www.astm.org.
con nuous monitoring system. 2. U.S. Food and Drug Administra on,
Pharmaceu cal CGMPs For The 21st Century – A
l To determine cleaning re-valida on intervals, a Risk-Based Approach, September 2004.
risk analysis can be performed to jus fy a longer 3. Interna onal Council for Harmonisa on of
me between re-valida ons for indirect Technical Requirements for Pharmaceu cals for
product contact parts vs. direct product contact Human Use, ICH Q8, Pharmaceu cal
parts, or to jus fy sampling only at high-risk Development, August 2009.
process steps, rather than all steps. 4. Interna onal Council for Harmonisa on of
Technical Requirements for Pharmaceu cals for
l For equipment matrixing, group equipment Human Use, ICH Q9, Quality Risk Management,
composed of similar materials so only a subset November 2005.
of the equipment needs to be tested during 5. Interna onal Council for Harmonisa on of
cleaning valida on, including determina on of Technical Requirements for Pharmaceu cals for
dirty hold mes. Human Use, ICH Q10, Pharmaceu cal Quality
System, June 2008.
l Cleaning verifica on can be performed prior to 6. Interna onal Council for Harmonisa on of
comple on of cleaning valida on. Technical Requirements for Pharmaceu cals for
Human Use, ICH Q11, Development and
Conclusion Manufacture of Drug Substances (Chemical
En es and Biotechnological/Biological
By using pre-approved forms and master protocols En es), May 2012.
and by u lizing risk-based approaches to determine
which valida on ac vi es to perform and for Source: Samsung Biologics. This is an execu ve
se ng re-valida on me intervals, the efficiency summary of the webinar.
and compliance of the valida on process can be
greatly enhanced over tradi onal methods. The (Visit h ps://audit.samsungbiologics.com to watch
examples provided are approaches many the complete webinar).
companies have adopted to streamline valida on
while maintaining GMP regulatory compliance.

References

1. American Society for Tes ng and Materials,
ASTM E2500-20, Standard Guide for
Specifica on, Design, and Verifica on of
Pharmaceu cal and Biopharmaceu cal
Manufacturing Systems and Equipment, ASTM

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Mini Fluid Bed Coater

The Fabtech Mini Fluid Bed Coater (Mini FBC) is ideal for drying or granula on/coa ng trials of very ny
batches ranging from 150 g to 350 g. This compact miniature machine is easy to handle and clean. Its unique
features make it ideal for use in pharmaceu cal research and development laboratories and formula on
trials par cularly involving expensive ac ve ingredients & excipients.

FBC highlights: Salient features:

l Plug & Play Machine l All contact parts are 316L
l Top & Bo om Spray l TC Clamps & Gaskets for easy dismantling
l Batch Capacity 150 to 350 g
l Compact Design during cleaning
l Use for Drying or l Easy cleaning and handling
l Compact Blower ensures perfect fluidiza on
Granula on/Coa ng opera on
for micro batches
For more details: l Acrylic Transparent expansion chamber ideal
Fabtech Technologies Private Limited,
[email protected] for visual process monitoring
www.fabtechnologies.com l PLC based controls ensure data integrity &

enhanced process control

SNIPE www.ipmma.org

- Heat seal inspection system

Snipe is an online heat seal inspec on system for retrofit onto
exis ng bo le packaging lines.

Poor induc on seal quality remains a serious concern in the
pharmaceu cal industry. Substandard seals can lead to
contamina on and reduced potency when exposed to harsh
environments.

Using the latest in high resolu on thermal technology, Snipe
accurately detects any areas of poten al leakage on a seal, verifying
the integrity of the bo le/pouches/s ck pack and rejec ng any
defec ve products via a customised rejec on mechanism.

Snipe has many features like it is designed to reduce any unnecessary
stoppages in produc on, new variants can be effortlessly added by
any operator, using military grade thermal imaging to achieve
accurate high throughput, minimal space requirement on the
produc on line, easy to retrofit.

Snipe can ensure a highly efficient and automated quality control
process to provide high quality product in a contactless and non-
destruc ve way, reduce and prevent the need of manual checks
which is very inefficient in terms of resource and me.

For more details visit: www.spookfish.vision | Call: +91 9108 993 345

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ASSOCIATION NEWS IPMMA conducts its 20th AGM
in a phygital way

The IPMMA 20th Annual General Mee ng Members appreciated and
(AGM) was conducted on November 13, 2021 thanked Mahendra Mehta for
at The Club, Andheri, Mumbai along with the his Presidentship for the
Video Conferencing (VC). period 2015-2021. IPMMA
scaled new heights under
Harshit Shah, Hon. Secretary welcomed all the Mahendra Mehta's leadership
members and thanked them for their presence. with several proac ve
Members present were very happy to meet and ini a ves taken with a
greet one and all in person which was not possible collabora ve team approach.
since more than one year. Members appreciated and
applauded Mahendra Mehta
Two minutes silence was observed as a homage to for his dedica on during his
all the members and their family members who le presidentship. Various ac vi es including
for the heavenly abode. Membership drive, IPMMA website revamp, Social
Media drive and more were presented to the
Following were few of the key points members.
discussed/shared:
All the members are excited and eagerly looking
1. IPMMA member's directory would soon be forward for Pharma Pro&Pack 2022 scheduled to be
available as so copy. held on 15-17 September 2022 at Hitex, Hyderabad.

2. IPMMA Advisor Kaushik Desai is working closely
with Indian Pharmaceu cal Alliance (IPA) and
academia for dra ing Good Engineering
Prac ces documents for pharmaceu cal
professionals. Plans for a cer ficate course on
Pharmaceu cal Engineering is also on the cards.

3. During year under review, IPMMA signed MOU
with AAiPS, USA (American Associa on of Indian
Pharmaceu cal Scien sts), FICCI and Messe
Muenchen India Pvt Ltd (MMI).

4. Virtual presence of IPMMA in 2021 was quite
strong, evident with the two mega virtual expos
and eight knowledge webinars suppor ng the
organizing associa on and industry bodies.

5. Pharma Pro&Pack magazine has got a new look
and it is very much appreciated for its content,
new features and quality.

6. Through IPMMA representa ves in EEPC,
members are in process of receiving their
mul ple export grievances resolved at a faster
pace.

The new Managing Commi ee members for the
period 2021-22 to 2023-24 were unanimously
elected during the mee ng.

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ASSOCIATION NEWS Indian Pharmaceutical Alliance (IPA)
announces Samir Mehta as President
(2021-2023)

Indian Pharmaceu cal Alliance (IPA) announced be collabora ng with
on Monday, October 04, 2021 the appointment stakeholders to strengthen
of Samir Mehta, Chairman of Torrent Group as the accessibility of
President of the IPA for 2021-2023 and Samina medicines and help in
Hamied, Execu ve Vice Chairperson, Cipla as the crea ng an Innova on
new Vice President. ecosystem that will be
beneficial to the pa ents.
Speaking on the new role, Mehta said, Covid-19 has
been a challenging me for the Indian IPMMA has been
pharmaceu cal industry . However, the Industry has collabora ng with IPA for
risen to the challenges and ensured con nuous mutually beneficial ac vi es like webinars and
supply of medicines to pa ents. The pandemic has more. IPMMA congratulates Mr. Mehta for the
further highlighted the significance of collabora on, coveted posi on and wishing him the very best for
access to affordable medicines and Innova on to further advancing ac vi es of IPA under his
respond to the country's healthcare needs. IPA will leadership.

CPhI Pharma Awards:
Chakravarthi AVPS and
Shri S.V. Veeramani

IPMMA congratulates Chakravarthi AVPS, Managing Director - Ecobliss India
for a special recogni on for his Outstanding contribu on in the pharma
packaging sector. Mr. Chakravarthi has been a strong supporter and very
closely associated with IPMMA as Advisor for guiding several path breaking
ini a ves .

IPMMA also congratulates Shri S.V. Veeramani, Former Na onal President www.ipmma.org
IDMA and CMD - Fourrts Laboratories for being awarded as a Pharma
crusader of the year. Shri Veeramani has been also elected as Vice Chairman
of Pharmexcil, a body under Ministry of Commerce recently. IPMMA has been
fortunate to have Shri Veeramani's con nued support and wisdom in ac vi es
benefi ng pharma fraternity.

78 PHARMA PRO&PACK | OCTOBER - DECEMBER 2021

Handbook of Pharmaceutical BOOK REVIEW
Granulation Technology - 4th Edition

Edited by - Dilip M Parikh, City, scale-up, role of excipients, advances
in process controls and End-point
DPHARMA Group Inc., determina on provide an excellent
insigh ul to the development and
10309, Kingsbridge Road, Ellico manufacturing professionals in
MD 21042, USA understanding every aspect of
granula on technology.
Publisher: CRC Press;
Taylor & Francis Group: The chapters on Op misa on
Series: Drugs & Pharmaceu cal Sciences; Strategies, Tools, and Regulatory
ISBN: 9780429320057 Considera on provides an excellent
overview in the emerging use of AI,
Pharmaceu cal science is progressing to and regulatory pathways. It also
the next level with each passing year. The touches upon Process Analy cal
Oral Solid Dosage (OSD) forms are in the Technology (PAT) tools and the Quality by Design
forefront globally and occupying the highest approach in the formula on development.
posi on with respect to its acceptance and
consump on. The development scien sts are To summarise, the important highlights of the book
always on the lookout for finding be er ways to other than detailed chapters on every aspect of
produce OSD forms with higher efficiency. granula on science include ICH Q12 coverage
Granula on of tablet dosage form is one such through Product Life Cycle management, USFDA
process which requires in-depth study. The Editor, guidance on Con nuous manufacturing and
Dilip Parikh has made incredible efforts in compiling discussion thereof, Role of excipients, Emerging
all the advances of granula on science from 50 Par cle engineering technologies and
authors and co-authors from all over the globe and characterisa on and dynamics of using various
presented in a very lucid and simple language with machinery.
examples and case studies. The efforts are
commendable and deserve much apprecia on The book is designed to enthral the readers with a
especially during this prevailing Covid-19 pandemic. comprehensive knowledge in the area of latest
I would like to place my rich compliments to all the developments in granula on science. The inclusion
subject ma er experts for their valued contribu on. of the common regulatory audit observa ons in
granula on processes would have been an added
Since the publica on of 3rd Edi on of this handbook advantage to readers in understanding the
in 2009, the con nuous granula on, ar ficial importance of granula on techniques. The
intelligence (AI), automated processes have come to handbook is more suitable for professionals from
the fore suppor ng the product development and product development, manufacturing, quality
manufacturing of OSD forms. The importance of assurance, and academia. The book will also be of
par cle engineering, and process controls has been special interest to pharmaceu cal and machine
gaining more prominence in granula on science. design engineers. The handbook is highly
recommended as a reference source for research
A er the ini al introductory, Chapter 2 deals with libraries and pharmaceu cal scien sts.
the theory of granula on with emphasis on
engineering aspect. The subsequent chapters are The handbook is available on amazon.in and
divided in five sec ons for ease of understanding Routledge.com (publisher of the book website).
each facet of granula on technology. The addi on
of new chapters on par cle engineering, totally Reviewed by: Kaushik Desai; Pharma Consultant
revised chapter on wet granula on techniques of and Advisor, Indian Pharma Machine
modern drugs, category of product specific Manufacturers' Associa on (IPMMA);
granula on (e.g., effervescent products, plant [email protected]
based products, nutraceu cals, melt granula on
techniques, and modified release products),
Advances in nano technology, characterisa on and

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