IPMMA Magazine - October December 2021

Vol 11 Issue 3 October - December 2021

Goodbye 2021, EVOLUTION
Welcome 2022 !
OF PHARMA
MACHINERY

IPMMA CELEBRATING

YEARS

2001 - 2021

Rajmal Mehta, New Elected
Chairman and Founder President - IPMMA
Parle Global Technologies Pvt. Ltd.
Harshit Shah







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CONTENTS

An official Publica on of Indian Pharma Machinery Manufacturers’ Associa on (IPMMA) 4 President's desk
6 IPMMA Execu ve Commi ee (2021-2022 to 2023-2024)
Vol 11 | Issue 3 | October - December 2021

An official Publica on of IPMMA

8 Evolu on of Indian Pharma Machinery Manufacturing in India

Indian Pharma Machinery 14 Leaders In-Sight
Manufacturers’ Associa on 18 Two decades of Glory and Grandeur of IPMMA
26 Preparing for the Worst-case scenario - Laboratory Con nuity Plan
PUBLISHER 28 How to prepare for con nuous manufacturing by automa ng
IPMMA
the transfer of powders and tablets
EDITOR
Harshit Shah 32 Safeguarding with Industrial Electrical Safety
36 Survey Results Remote Factory Acceptance Tests (Remote FATs)
TRUSTEE
Bhavna Shah 42 Good Distribu on Prac ce (GDP) – Q&A
Rajesh Shah 44 Adver sers’ Index
Ratan Singhania 46 Why Don't OEM Recommenda ons Work for Maintenance?
Vinod Padia 52 Decentralised manufacturing: how outsourcing is helping to
Mahendra Mehta
bring the personalised medicine promise to reality
PRESIDENT
Harshit Shah 56 Best Prac ces for Effec ve Quality Documenta on Processes
in Drug Manufacturing
VICE PRESIDENT
Shehul Sheth

HON. SECRETARY
Oswin D'souza

ADVISOR
Kaushik Desai

EDITORIAL SUPPORT
Harish Panchal
Parag Jawale

ACCOUNTS
Anil Kumar Mehta

CIRCULATION
Rajkumar Prajapati

CORRESPONDENCE ADDRESS 60 The Hidden Cost of Inefficient Laboratory Prac ces
Indian Pharma Machinery 66 Efficiency for Valida on - Con nuous Change and Improvement
Manufacturers’ Associa on 72 Product Showcase
(IPMMA) 74 Associa on News
76 Book Review
20, Suyog Industrial Estate, L.B.S. Marg,
Vikhroli (West), Mumbai 400 083, INDIA

Phone No : +91-9004377743
Email: [email protected]
Web: www.ipmma.org

Opinions and information shared by the
authors of individual articles or an

advertisement do not necessarily represent
official view and endorsement by IPMMA

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President's desk

Harshit Shah

'Leadership is the capacity to translate vision into reality' ~ Warren Barris

Dear Readers,

It has been a great associa on with IPMMA since many years and today I stand the chance to write here from the desk
as the President of this august organisa on. It is an absolute honour to serve in this stature and to be given the chance
to contribute towards the larger vision of the en re team of our Indian Pharmaceu cal Machine Manufacturers to
translate it into reality and reach newer heights. I thank all IPMMA members for entrus ng me with this responsibility
and managing this new posi on.

IPMMA now completes a glorious 20 years journey and I believe that each passing year teaches us to aspire towards
fulfilling our goals and each New Year brings in more posi vity and brighter chance to turn that vision to a reality.

Each new year brings in more posi vity and brighter hope for a be er tomorrow. Its more so, while we welcome year
2022 a er our recent pandemic experience which was completely unexpected. As its rightly put “This too shall pass”,
although the new variant is on the horizon, most of us are supposedly much prepared in all ways possibly. Having said
that, “preven on is be er than cure”.

In 2022, we are working towards giving IPMMA a makeover with its digital presence and deploying web services such
as Surplus Inventory and Product Lis ng for leveraging more benefits, however on the same note I request all our
members and stakeholders of the organisa on for their con nued support to ensure we fulfil the IPMMA vision to set
new benchmarks in the coming years. We request all our members and stakeholders to con nue their enduring
support in crea ng new benchmarks and reaching higher milestones.

IPMMA has come a long way and it's a big responsibility of me and the team to reach higher milestones specially a er
successfully nurturing for last two decades. Do not miss the special coverage of 20 glorious years as IPMMA celebrates
its 20th birthday!

We are excited and eagerly looking forward for our premier event “Pharma Pro&Pack Expo 2022” scheduled to be held
from 15-17 September, 2022 at Hitex, Hyderabad.

Let us all happily welcome the New Year 2022 and not let the pandemic make us feel constrained but rather be
prepared to achieve our milestones given all possible odds.

Stay Safe and Wishing you all Happy and Healthy New Beginnings!

Yours Truly,

Harshit Shah www.ipmma.org
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COVER STORY Evolution of Indian Pharma
Machinery Manufacturing in India

Dynamically complying with global regulatory standards, growing global markets, mee ng
pace of amplifying healthcare and medical demands, rapid machine upgrada on and
innova on ahead of me, the India pharmaceu cal industry has come a long way growing
through cascading challenges yet staying competent with interna onal markets.

Looking through the lens of IPMMA past presidents, the editorial team helps you walk through the journey of
India pharmaceu cal industry through past few decades.

Bhavna Shah, need. These engineering companies envisioned a
great opportunity for growth and commi ed
Ex-director - Pharmalab themselves towards fulfilling the requirement. In
IPMMA PAST PRESIDENT spite of challenges such as lack of resources, skilled
[2002 - 2008] manpower and infrastructure, these companies
started manufacturing the equipment and
Over the last six machinery with the available resources.
decades, the Indian
Pharma Machinery The a tude of focusing on product quality right
Manufacturing Industry from the ini al stage kept the engineering
has taken a big leap companies on the compe ve edge. The locally-
from being a local made Pharma equipment exceeded the expecta on
supplier to Indian of the pharmaceu cal companies which
Pharmaceu cal encouraged them to work more with these local
companies becoming a companies for their requirements. Over a period,
globally accepted / recognized equipment the engineering companies built the infrastructure,
manufacturer. added resources & skilled manpower and
developed technology to match the local demands.
In the olden days, the pharmaceu cal
manufacturing companies opera ng in India, Further, the evolu on of Indian Pharmaceu cal
especially the MNCs, prac cally had no local manufacturing companies led to growth in demand.
equipment manufacturer to fulfil their requirement. This in turn led to an explosion in the Pharma
Impor ng from the west was the only op on then. A Machinery segment, it not only grew the exis ng
period in the Indian economy faced severe foreign players, but the demand was extremely lucra ve for
exchange crunch, resul ng in government imposing a new player to enter the same market. This
foreign exchange restric ons and other policies that compe on helped us to make quality products
discouraged imports, which led to the emergence of that were available at affordable prices.
Pharma machinery manufacturers in India.
Through past few decades, other countries
The pharmaceu cal manufacturing companies then recognized quality and accepted the products of
ini ated dialogue with a few of the local engineering Indian pharmaceu cal manufacturers and they
companies to develop the equipment that met their evolved into exporters. Today, India has the highest
number of USFDA approved plants outside USA. The

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dedicated efforts on R&D led to innova ve product manufacturers were making reasonably good COVER STORY
development by Indian Pharma companies that machines with availability of locally manufactured
turned India into the “Pharmacy of the World”. India components keeping industry growth at limited
globally stands as the third largest producer of pace. But over a period of me, with change in
pharmaceu cals by volume. policies imports were open. To match with the
advancement in global market and to complying
Similarly, the progress in innova on and capability with the ever-changing dynamics of global
to meet the interna onal standard & quality by requirements, machinery industry is also upgrading
Indian engineering companies directed the western and innova ng technologies con nuously.
pharmaceu cal-equipment manufacturers to
believe and collaborate with us for future business. Like a double-edged sword, the revised policies
Today, the Indian pharmaceu cal equipment made machinery import easy however it eventually
manufacturers have become an integral part of the increased compe on amongst local
global fraternity. manufacturers, which was kind of a blessing in
disguise. In the spirit of compe ng the
The exponen al growth in demand, immense manufacturers upgraded themselves.
poten al and ever-changing regulatory
requirements calls for a different and innova ve Machinery upgrada on is a process and
approach from the Pharmaceu cal-equipment con nuously evolving to adept the dynamics of
manufacturers. Now is the me for the engineering regulatory requirement of pharmaceu cal industry.
companies to start adop ng the next-genera on The Indian pharma machinery is booming, giving
technologies such as robo cs, AI, IoT, virtual reality, tough compe on to global players now.
machine learning, industry 4.0 etc. This
technological advancement will aid the engineering The pharma market expected are to cross USD 1.5
companies to address several internal challenges trillion by next year, having tremendous poten al
such as opera onal inefficiency, sub-standard and providing huge opportuni es to machinery
quality, re-work, wastages and increase their overall manufacturers in India. With 17,000+ pharma
produc vity. Whereas these advancements will companies, India is 4th largest and having the
enable engineering companies to be preferred highest number of FDA approved outside USA itself.
partners of the pharmaceu cal manufacturers in It empowers machinery manufacturer to produce
addressing their challenges, fulfilling their ever- and compete with EU manufacturers in terms of
growing demand and complying with the stringent quality features and various automa on being
regulatory requirements. offered in the machines priced economically.

Rajesh Shah In addi on, steadily increasing Joint Ventures,
technology transfer in both the fields itself is a
Founder Chairman - Maharshi Udyog tes mony to the technological advancement in
IPMMA PAST PRESIDENT industry. By being in this industry for more than 4
[2008 - 2014] decades, we are capable of bringing out a
transforma on in this sector by quality, technology,
In early days, the customer-care and of course the sales volume will
imports in India were achieve great heights.
rela vely difficult due to
import policies, foreign
exchange availability etc
but s ll the machinery

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COVER STORY Ratan Singhania demand of around 10,000 pharma manufacturers
of India. By 2000, there were 200+Pharma Machine
Director - Singhania Table ng Manufacturers at different scale.
IPMMA PAST PRESIDENT
[2014 - 2015] In 2001, all such manufacturers collaborated and
formed IPMMA, Indian Pharma Machinery
The pharma machinery Manufacturers' Associa on.
manufacturing
companies started Our present market growth rate is between 10-15%
around 1960. During with around 800 small and big machinery
this me, only two manufacturers.
limited company
namely ACG and Owing to several collabora ons today India is
Gansons along with almost self-sufficient for Pharma Machinery. In
handful of companies India we can now manufacture fully automa c
by technocrats like Pharmalab, GPMC, Vivek machines quite closer to the technology of
Grower, Ambica for solids and liquids were developed countries
func oning in India.
Many of the global pharma manufacturer are
During those early years major pharma market was dependent on Indian machinery as they are quite
through the mul na onal pharmaceu cal robust and cost effec ve. India has also grown
companies and most of the equipment were strong in interna onal service support to client,
imported. As Indian market size was quite big in which gives more value addi on.
terms of volume, all pharma machinery
manufacturers were under pressure to grow with In the near future, India is likely to become, most
domes c machineries. prominent Pharma machinery manufacturer in
global market. Indian machines provide best in
Around 1970, Indian government started pu ng terms of value for money. Currently as many as 50+
restric ons and imposing heavy du es on imported countries are mostly dependent on Indian
pharma machines which in turn put pressure and machines. I hope to have a very bright future for
prompted Indian pharma machine sector to grow. Indian manufacturers.
In 1971, first double rotary tablet press was
manufactured in India and many companies Mahendra Mehta
followed suit with different machines and they
started growing eventually giving a boost to pharma CEO and MD - Parle Global Technologies Pvt. Ltd.
machinery sector. IPMMA PAST PRESIDENT
[2015 - 2021]
From 1980, exhibi on era started by ITC all over
India giving a big boost to this sector. In 1980, India It is with pride I feel that
started expor ng to Bangladesh, Sri Lanka, Pakistan Indian Pharma machinery
and several neighbouring and developing has evolved a lot over the
countries. years. From being an
impor ng country, today
In 1990s Indian companies started par cipa ng in we are expor ng our
overseas markets and today India is expor ng equipment's across the
machines to 100+ countries and fulfilling the globe including the

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COVER STORY developed na ons. We have adopted latest spares and services. It also helps save foreign
technology in the manufacturing set up and hence currency to be retained in the country.
able to now cater to the most precise requirements
of the industry. Further the IT strength of our The Indian machinery industry is also inves ng a lot
country has helped our manufacturers adopt the in R&D and process development. The qualified
latest automa on and control mechanism to avoid English-speaking engineering strength of India is the
defects in manufacturing and alert for any backbone to such innova ons. We find Indian
malfunc ons. The equipment is built more as a companies are able to connect with the global
system instead on skill dependent. The Indian technology in terms of engineering to adopt them in
machinery industry has developed good knowledge the manufacture of the pharma machines. The
in Solid Oral Dosage applica ons like Tablets, adop on of robo cs and pick & place mechanism
Capsules, So Gela n, Packaging etc. We may s ll has made us build machines which are totally
need to invest in Injectables with which we are automated and man less in opera ons.
confident we'd soon to be at par with quality of the
global players. Indian Pharma Industry has proven The Indian pharma machinery industry has
itself mee ng global regula ons standards as well developed a lot over the years in the manufacturing
automa on requirements like CE cer fica on. of equipment and tools like Tablet compression
Press for Bilayer, Tri Layer, Core placement, Dies &
We also find Indian companies have entered in Joint Punches, Capsule Filling and much more. Joint
Ventures / Technology e up with Germany, Japan, ventures are flourishing now owing to its win-win
USA and more which is giving access to the local business approach. One of the key reasons
companies to be exposed to the best manufacturing interna onal markets take deep interest in Indian
and design prac ces. The low-cost manufacturing in pharma machinery industry is that it provides one
India with the design from the developed na ons is roof solu on to any pharma company to support
a lethal combina on which is beneficial to the with equipment right from processing to packaging.
Indian Pharma Industry to use the best equipment
at economical cost and local support in terms of

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Two decades of Glory IPMMA CELEBRATING 20 YEARS OF IPMMA
and Grandeur of IPMMA
YEARS

2001 - 2021

Indian Pharma Machinery Manufacturers' the need of the hour, a like minded group of pharma
Associa on (IPMMA) was founded on 23rd machine manufacturers came together in 2001 to
December, 2001 at New Delhi and was registered form an associa on and register it as IPMMA which
as a trade not for profit associa on to represent now stands tall with a great deal of achievements
specifically the Indian pharmaceu cal machinery under its wings. IPMMA as an associa on has been
manufacturers. recognized by several government, semi-
government, trade councils and leading pharma
IPMMA celebrates the 20 glorious years of serving associa ons. It is a great pride for the associa on
relentlessly as the voice of the Indian Pharma that its members already export their products to
Machinery Manufacturers. IPMMA with its 80+ countries spread across five con nents.
commi ee members, all past presidents and each
and every member takes pride in sharing Having relentlessly working as voice of and for the
walkthrough of the two decadal journey of sheer Indian Pharma Machinery Manufacturers for past
determina on and will to serve the industry for two decades, IPMMA has established its credibility
mutual growth and contribute in the progress of the through na onal and interna onal pharma
pharma sector. industry. IPMMA has been able to achieve all these
accolades with due support from other industry
Indian pharmaceu cal machinery manufacturers associa ons, trade fair organizers, government
have been one of the key contributors in the growth bodies and most voluntary con nued support of
story of the Indian pharmaceu cal industry. Seeing members.

IPMMA Objec ves

l To work towards the benefit of all the manufacturers of pharmaceu cal machinery.
l To par cularly give encouragement and recogni on to small scale machinery

manufacturers.
l To get recognized by Na onal and Interna onal Pharmaceu cal Industry

associa ons.
l To get recognized at the Central Government offices
l To ensure maintenance of fair business prac ces in the pharmaceu cal industry.
l To encourage unity and provide mutual help within the members.
l To organize mee ngs / seminars / conferences / exhibi ons / trade fairs as required

by the members.

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20 YEARS OF IPMMA IPMMA CELEBRATING

YEARS

2001 - 2021

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IPMMA CELEBRATING

20 YEARS OF IPMMA MILESTONES YEARS

2005 2001 - 2021

2007
Launched IPMMA Newsle er

EEPC and FICCI 2011
membership
Worldwide recogni on Launched Pharma 2021
by Interna onal Pro&Pack Magazine
Pharma Exhibi ons Conduct of series of webinars in
and Associa ons BAPI 2013 associa on with allied pharma
(Bangladesh) , KPM associa ons
and FEAPM (Kenya), 2016 Mega Launch of Introduc on of new features for
KPMA and KOTRA flagship event Pharma members on website
(Korea), MOPI and Pro&Pack Expo and Conduct of first AGM phygitally
PHAMA (Malaysia), Roadshows
APPON (Nepal), Unveiling of the IPMMA Corporate
PMG-MAN (Nigeria), 2020 Video
PPMA (Pakistan) Signing of MoU with American
Launched IPMMA Felicita on of IPMMA Associa on of Indian Pharmaceu cal
website members comple ng Scien sts (AAiPS)
(www.ipmma.org) 50 years of service to Suppor ng partner at first Global
Well recognized by the industry Virtual Healthcare Expo 2020
EEPC, FICCI, IDMA, organized by FICCI
IPA, ISPE, OPPI and IPMMA signs MOU with Ac ve Social Media presence
Pharmexcil. BAPI (Bangladesh)

2003

2017

Holds its first Seminar: Par cipa on at 2019 signing of MoU with Exhivision Media
Schedule 'M’ Gujarat Expo & Pvt. Ltd. for Amptech India 2019
2002 INTERPHEX, USA
Elected Patron members Revamping of Pharma Pro&Pack
magazine

2018

2001 Signing of MoU with Messe Muenchen
India for Pharma Pro&Pack Expo
IPMMA Founded and Par cipated in Korea Pack and Pharmtech
Registered on 23rd December & Ingredients Expo, Russia

Future Plans

l IPMMA would soon be making available member's directory for the benefit of the stakeholders at
a nominal price.

l The Surplus Inventory sec on under IPMMA website is set to benefit each and every member
helping manage their inventory be er.

l Upskilling program to be run by Central Government Cluster Program in Maharashtra.
l Cer ficate course on 'Pharmaceu cal Engineering' for bridging the industry-Academia interface.
l Expand outreach by collabora ng with na onal and interna onal bodies for exhibi on and other

value-added ac vi es.

The Best way to predict your future is to create it – Abraham Lincoln www.ipmma.org
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PROCESS How to prepare for continuous
manufacturing by automating the
transfer of powders and tablets

The benefits of con nuous manufacturing manufacturing. He also adds that the best prac ce
compared to batch manufacturing to set up con nuous manufacturing must be an end-
to-end approach whereas all process steps are
The way in which pharmaceu cals are produced is “built-in” with plant-wide integra on which allows
about to change. immediate reac on in case of any devia ons.

Batch manufacturing is replaced by con nuous The tablet transfer problem
manufacturing, to ensure a faster and more reliable
process. The FDA's Nonbinding Recommenda ons Even automa ng certain steps can take the process
describe the considera ons poin ng to the to the next level. Transferring powders during the
implementa on of the shi towards con nuous process (for example to and from a tablet press) and
manufacturing – material transfer connec ons the transfer of the finished tablets to a packaging or
being one of the characterizing factors of the blister packaging machine are o en done manually
recommended system setup. which doesn't only affect the product quality
nega vely due to material segrega on and
Mul -step batch processes have been in place for contamina on, but it also implies safety risk for the
decades in the pharmaceu cals industry – simple operator. By automa ng the powder and tablet
and well-known as they are, they imply a lot of transfer, the first step is made towards con nuous
challenges when it comes to material contamina on manufacturing.
and produc on speed. During batch manufacturing,
hold mes may occur between produc on steps and Tablets are usually moved around the
the transferred materials are o en added manually manufacturing plant, from one processing unit to
to the equipment. Not only will the material be in another, for instance from a coa ng drum to a
contact with air (and thus with contamina ng packaging line.
factors), but the consistent high quality is also hard
to maintain. Scaling up is also challenging and the The me-consuming and some mes back-breaking
whole process has a rela vely large footprint: there manual labour is the result of a wide-spread fear
is a bigger need for storage and the material flow is that very delicate and valuable tablets will be
handled manually. chipped or damaged in an automated conveying
system. For obvious reasons, any damage to a tablet
Con nuous manufacturing allows a non-stop flow of
the materials between pieces of equipment with
possibili es of automa c monitoring and a
produc on line with fully integrated components.
This not only saves me, but also contributes to
waste reduc on by ensuring higher quality with less
product recalls and lower risk of contamina on.

According to Dr. Bayan Takizawa, CBO of a Novar s-
MIT spin-out company, “processing mes are
decreased, unnecessary steps are eliminated, and
the en re process is streamlined from start to finish
(no more stops and starts).” in con nuous

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renders it useless, and pharmaceu cal companies adjusted depending on table proper es. PROCESS
usually accept very li le waste within the process
due to the high cost of the finished product. Manufacturers should look for a vendor that can
Chipping and other damage should be avoided provide a selec on of accessories op mized for
during transfer by gentle handling. transfer of tablets.

Vacuum conveying to enable gentle conveying of Filtra on
tablets and capsules
Uncoated tablets o en create a lot of dust, which
With the development of technology, vacuum needs to be separated from the tablets before
conveyors have advanced to be able to replace packaging. This is easily achieved by the addi on of
manual labour in handling delicate objects. a cyclone-like pre-separator in which the dust is
Elaborated below are the key aspects to consider sucked towards the vacuum pump, whilst the
when choosing a vacuum conveyor for the transfer heavier tablets drop down into a container. The dust
of tablets. is then filtered out before it reaches the pump,
avoiding pump breakdowns. The amount of dust
Func onality of conveyor will determine the required filter surface, and dust
par cle size will decide how fine the filter mesh
Just as you need to handle delicate objects carefully needs to be.
by hand, an automated conveying system needs to
be designed with careful handling in mind. The key Filters are an important and integral component of
to this is speed. The opera ng speed of any conveyor a vacuum conveyor system. They offer protec on
must be appropriate for its applica on, and to make for machinery such as vacuum pumps, but also help
sure that delicate tablets stay intact. It is important to protect the operator from inhala on of the dust
to look for conveyors and pumps which can achieve from tablets, poten ally containing medically ac ve
adjustable speed based on the material substances.
transported, to suit various type of tablets.
Some manufacturers offer conveyors that can be
Solu ons for different product types equipped with High Efficiency Par cle Assay (HEPA)
filters, which filter 99,9% of all dust par cles.
Tablets don't only vary in size and shape, but can also Addi onal types of filters are available for powders
be coated, uncoated, hard, or so pressed. For with a par cle size of greater than 0,5 microns.
capsules, size and shape considera on is important.
All these characteris cs need to be addressed with The key to successful filtra on is to choose a
specially adapted equipment for the products to be supplier that offers a substan al range of filters for a
transported safely and gently through the plant. wide variety of tablets.

Coated tablets may seem easy to handle due to their Hygienic and easy to clean solu on
hard coa ng. However, the coa ng is suscep ble to
cracking if the tablets hit hard surfaces or sharp Hygiene is of fundamental importance to the
edges along the conveyor system. Therefore, it may pharmaceu cal industry, and regardless of the type
be more appropriate to use a flexible hose rather of tablets they transport; conveyors must be kept
than steel tubing, and to smooth out edges with a clean. However, cleaning me means down me, an
protec ve silicone lining. A star-shaped or undesirable produc on pause.
otherwise angled tablet may suffer grinding not only
from hi ng the conveyor walls, but also from Conveyor systems with a minimum number of
colliding with each other. To avoid such collisions, moving parts that can be assembled and
the tablet flow rate may need to be regulated and disassembled without tools offer minimal

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PROCESS produc on stops for cleaning or other maintenance within the plant – without cracking the tablets.
work. Modular systems are also easier and quicker
to clean or otherwise maintain. Faulty or damaged Other important aspects to consider when
parts can be extracted and replaced with very li le choosing right vacuum conveyor are: Cer fica on
disrup on to the produc on process (ATEX, FDA, EN1935/2004 and EN 10/2004) and
Warranty.
Lab tes ng
Conclusion
As it offers the opportuni es of a fully automated
and sealed system, a vacuum conveyor is a superior Many pharmaceu cal companies are preparing for
solu on for tablet handling. However, many or in the way of transforming their produc on lines
different op ons and configura ons need to be for con nuous manufacturing due to a long list of
considered before you can arrive at a system that is benefits including higher product quality, smaller
fit for purpose and results in minimal tablet equipment footprint and automa zed possibili es
damage. Hence, lab tes ng is a vital step in the for monitoring.
conveyor selec on process.
When it comes to process op miza on, material
Some manufacturers offer tes ng facili es in which transfer is a non-neglectable system component
you can test-run the equipment for your which determines product quality and loss and
applica on. A variety of conveying characteris cs enables con nuity between different pieces of
can be tested for different types of tablets and over equipment.
various ver cal and horizontal distances. Test-runs
will also provide a basis for analyses of the volumes Vacuum conveying is becoming an industry
conveyed per minute over a given distance, as well standard when it comes to powder and tablet
as the vacuum cycle me and the energy transfer from one process step to the other without
consump on. In addi on, tes ng can help to allay compromising on health and safety, product
fears or correct misconcep ons associated with quality, and footprint.
unknown technology. For instance, the idea that
vacuum systems are noisy can readily be put to rest. Source: Piab Whitepaper ( 08.10.2021)
However, and most importantly, tes ng will help to
crack the problem of transporta on of tablets

Fee

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REGULATORY UPDATE Survey Results Remote Factory
Acceptance Tests (Remote FATs)

With the revision of Annex qualifica on ac vi es, 17 (21 %) par cipants are
15 in October 2015 new from a "Q-department" (QM, QA, QC). Five are
equipment qualifica on consultants, also five respondents work in a
steps are men oned - Factory technical department (6 % each) and another five
Acceptance Tests (FATs) and Site are CEOs/Managing Directors.
Acceptance Tests (SATs) as a
“may-op on”. But in fact, these two Almost 45% of 83 par cipants come from
ac vi es are o en used to reduce companies with more than 500 employees, just
the qualifica on workload. This over 30% are employed in companies with 100-500
concept is also men oned in employees. The remaining par cipants are divided
different guidelines, for example, in between companies with 1-50 (8%) and 50-100
ECA`s Integrated Qualifica on and (15%) employees.
Valida on Guideline, which
describes a strong partnership The first ques on was: "Are you using remote FATs?
between suppliers and customers to receive a GMP 56% of the 140 par cipants answered yes,
compliant but also streamlined equipment corresponding to 44% not using remote FATs. Those
qualifica on result. answering that they do not use FATs were also asked
"Why not?" The answers (32 par cipants) were
However, due to the Covid-19 pandemic personal heterogeneous, but some answers can be clustered.
presence of pharmaceu cal customers at the Seven par cipants answered FAT was not necessary
supplier site has generally been reduced or even (e.g., only small equipment was qualified), another
become impossible - especially for FAT. So “remote- four par cipants said FAT on-site was s ll possible
FATs” came up more and more in the last year and and six par cipants thought that on-site is more
are s ll used. But how successful are such remote helpful and a FAT without seeing and touching the
FATs? What are the problems showing up? This was machine wouldn´t work. Other answers were e.g.,
something we wanted to find out from you, to get an no procedure available, don´t know how, etc.
overview - and therefore a survey was set up,
comprising seven ques ons. A total of 140 took part To the ques on "How many remote FATs have you
in the survey. In the following, you will find an conducted?" we received 75 answers, 21% out of
extract of the ques ons asked and their answers. which conducted one remote FAT, 51% 1-3 and 28%
Not all par cipants answered all ques ons, and conducted more than three remote FATs.
some mes several answers were given, so that, in
some cases, the percentages add up to more than Asked to rate remote FATs (excellent, good, average,
100%.
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The majority of 82 par cipants come from the
pharmaceu cal industry (over 60%), almost 15%
from the ac ve substance producing industry
(chemical and biological ac ve substances) and 6%
are equipment manufacturers as well as 3% are
manufacturing medical devices.

The type of par cipants with respect to their
designa ons like Head system, Engineer, QA
manager etc.. varied from 3 to 22.

31 (39%) par cipants are involved in valida on /

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REGULATORY UPDATE fair, poor). 31 par cipants (44%) rated them We also wanted to know what the precondi ons are
average, 24 (31%) good, nine (13%) poor and six that must be fulfilled to conduct a remote FAT
(8%) fair. One out of those answering to the ques on successfully. 48 par cipants answered. Nine of
(71 persons) rated remote FATs as excellent. them (19%) men oned a detailed FAT protocol plan,
eight par cipants (17%) recommended that the
What are the "pros" of remote FATs? This ques on remote FAT should be planned/organised with
answered 51 par cipants. The most frequent guidelines, agendas, agreements. Also, eight
argument for remote FATs was reduced (travel) me par cipants saw mul ple cameras with different
(26 answers, 51%). 17 par cipants (33%) like the angles as necessary. Three of those answering
cost reduc ons. Also men oned was higher/greater recommended good internet connec vity, good
flexibility (eight par cipants, 16%), more people, video technique and agreements how to handle
e.g., SMEs, can par cipate (six par cipants, 12%) electronic signatures. Two par cipants wanted to
and less contacts/don´t get sick (three par cipants, have a share point to share files/folders - and the
6%). Two respondents appreciate the reduced machine should be ready/built.
workload in comparison to on-site.
Finally, we wanted to know whether respondents
On the other hand, we asked where do you see the will con nue to use remote FATs also a er the
cons of a remote FAT? 52 par cipants answered. 14 Corona pandemic? - which 26 (56%) answered with
(27%) are missing the hands-on experience at the Yes, 21 (44%) with No.
machine at the supplier's site. Ten par cipants
(20%) stated that the rela onship between supplier Conclusion
and customer suffers. Can´t see enough details was
men oned eight mes (15%). Four par cipants Remote FATs are widespread today.
each men oned that internet connec on caused
problems, the documenta on review would be Over 50% of the par cipants conducted 1-3 remote
difficult and the big picture is lost and deficiencies FATs and even 28% more than three.
could have an impact on qualifica on. Also, three
par cipants (6%) argued that FATs require to trust On the other hand, 40% of the respondents are not
the supplier and that it is rather not possible for conduc ng remote FATs. Why not? They argued
complex machines. among other things that FAT was not necessary
(e.g., only small equipment was qualified) and six
par cipants s ll prefer on-site FATs.

The biggest advantages for remote FATs are seen in
the cost reduc on and the travel ( me) reduc on.
The biggest disadvantages are that during an on-site
FAT the hands-on experience is lost. Precondi ons
for remote successful FATs in the respondents´ view
are detailed FAT protocols/plans and a clear
planning.

The new version 2.0 of the Good Integrated and
Valida on comprises a subchapter about remote
FATs/SATs and an appendix with a checklist for
remote ac vi es as well as ps and tricks.

Source: ECA GMP Newsle er by ECA Academy
(The ECA Academy is the educa onal organisa on
established by the ECA Founda on. For details
kindly visit www.eca-founda on.org.

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www.beckhoff.com/xts-hygienic

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SUPPLY CHAIN Good Distribution Practice (GDP)
– Q&A

In October 2020, the European GDP Associa on these sites, therefore a RP in each site may be
(ECA) offered the Live Online Training "The GDP required depending on the nature of the company
Compliance Manager". During the Q&A sessions, as well as the scope of the licensed ac vi es. They
many interes ng ques ons were posed to the may report to a centrally appointed RP for
speakers' team. The ECA shares a selec on of these consistency and management purposes.
Q&As sorted by topic.
Q 2.5: Which en es need a RP?
Below you will find the third set of ques ons which
have been answered by the speakers' team. All A : All WDA holders must have a RP.
answers reflect the opinion of the speakers based on
their experience. Q 2.6: Can the provisions between RP and Deputy
RP be described in the Site Master File?
The role of the responsible person for GDP
A : Yes.
Q 2.1: Can the Responsible Person (RP) delegate all
type of tasks? What about even more cri cal tasks Q 2.7: Concerning annual training review of non-
such as release of product etc.? opera on staff performing GDP tasks: is it
mandatory that the RP review, document and sign
A : Provided the RP ensures that all delegated tasks this review or can it be delegated to QA personnel?
are properly documented and described in a formal
procedure and the person performing the task has A : The RP is responsible for ensuring that ini al and
been appropriately trained he/she can delegate the con nuous training programmes are implemented
performance of the task. However, the responsibility and maintained. How they conduct this is possible
for that task remains with the RP. through a number of different means and does not
always mean that they must sign individual reviews.
Q 2.2: What legally-binding documents would the A review of the en re process may be conducted
RP need to sign related to the products, besides through, for example self-inspec on.
Quality Agreements?
Q 2.8: In your experience, is there a
A : Apart from quality related document, no other background/profile that tends to be conducive for
requirement, but a company may choose to have being successful in the role of a RP - e.g., QP
their RP to sign of various documents. experience, people with logis cs background, etc.

Q 2.3: What is the impact of Brexit on RP A : This will depend on the nature of the company
requirements? and the ac vi es being performed. In general, the
RP should have experience performing similar
A : In UK, companies impor ng products from
approved countries need to have a Responsible
Person (import) (RPi), otherwise there is no change
to the role of RP in EU.

Q 2.4: Can QMR be RP or separate person to be
appointed? Also, company is doing warehousing
and distribu on and it has mul ple sites (e.g. 14
warehouse in the country in different loca on),
does it require to have RP for all sites?

A : RP is a specific role for WDA holders. QMR is a
defined role for companies handling APIs. If your
company has 14 sites across the country it is
unreasonable to assume one RP can manage all

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SUPPLY CHAIN ac vi es to the company in ques on. A broad base The RP's manager should understand the RP's role
of experience is useful as RP's tend to come across and ensure suitable training is provided.
issues across the en re supply chain/life-cycle of the
product. The best approach (whilst not always Q 2.10: If we are the contract manufacturer + 3PL
prac cal or possible) may be for the old RP and new for legal manufacturer/legal distributor who
RP to have a handover period or for the new RP to should have the RP employee in the organiza on
have been employed by the company for a period of chart?

me prior to taking on the role to ensure they are A : The holder of the WDA is required to have the
familiar with the products being wholesaled and services of a RP. If this RP is not an employee of the
opera ons conducted. legal en ty being the WDA holder, then a contract
should be in place between the RP employer and
Q 2.9: For the RP role & ongoing competency the WDA holder as the RP would be considered a
assessment, which func on is best placed to contract RP. This contract should set out the
oversee this: HR, Head of QA, Business Leader, …? availability of the RP to the WDA holder including
the number of days per month etc.
A : The RP themselves are o en well-placed to know
the areas where ongoing professional competence Source: European GDP Associa on
and training is required. Assessment of this may be
performed and reviewed by HR or the RP's manager.

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Techline Industries 17

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Transport Corpora on of India Limited (TCI) 65

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TECHNOLOGY Why Don't OEM Recommendations
Work for Maintenance?

During the Design, Build, Test phase of an how do we ensure that the asset performance will
asset's lifecycle, many organiza ons will meet those expecta ons? The answer is a
choose to start with maintenance and spare maintenance strategy, or more specifically, a risk-
parts recommenda ons from the vendors and based maintenance strategy. A maintenance
manufacturers of the equipment. On the surface, strategy is a rule set that establishes the tools to be
this appears to be a perfectly logical decision, right? used in determining the ac ons performed to
The vendors and manufacturers are the experts in maintain an asset in its ready state. A risk-based
the equipment they build? Nearly without fail, a few maintenance strategy involves evalua ng the
months or years pass, and the asset begins to fail rela ve impact of failure on the business and
unexpectantly. Why does this happen, and how can employing the rule set based on this input. To
we make this stop? execute this program effec vely, the organiza on
first needs a list of all of their assets and then
This ar cle will cover why manufacturer stra fying the assets across a set criteria. We
recommenda ons fail, the concept of risk-based recommend the following:
maintenance strategy, and how your organiza on
can op mize your assets' performance. 1. Safety: What is the level of exposure to
Operators and the Environment to hazardous
First, if the manufacturers are the experts on the situa ons?
equipment they created, why do their maintenance
recommenda ons fail? In short, opera onal 2. Quality/Compliance: In the event of a failure,
context. Manufacturers don't know precisely how what is the impact to compliance: none,
you intend to use the equipment. Many mes, if devia on, inves ga on, 483 warning, etc.?
they get the opportunity to see the context at a later
date, they will o en comment that their equipment 3. Cost: How much is spent annually on the
was not intended to be run in that manner. The most maintenance of the system to include service
effec ve way to solve this dilemma is to ensure your contracts?
User Requirement Specifica ons (URS) are very
clear and incorporate opera onal context. 4. Failure Probability: what is the Mean Time
Between Failure (MTBF) that is expected or
In addi on to process, its people, both those that historical?
operate the equipment and those that maintain it.
Manufacturers o en overlook a cogni ve 5. Availability/Produc on Demand: how does a
engineering approach in op mizing the failure of the system (including outage me)
performance of the equipment with human input; in impact the business at the current run rate:
fact, they mostly a empt to engineer out a human's a. None (completely redundant)
need to interact with the system altogether. With all b. Rework of product required
the best inten ons, people will need to interact with c. Loss of single batch
the equipment eventually. For maintenance, if your d. Loss of mul ple batches
organiza on purchases a service agreement with
the manufacturer, the equipment will likely extend The purpose of the cri cality evalua on is
its error-free life, but why? The manufacturer is the priori zing your finite resources and to focus your
expert in their equipment and will iden fy poten al
errors during a maintenance period before an in-
house technician who does not have the same depth
of experience.

If original equipment manufacturer (OEM)
recommenda ons fail to meet expecta ons, then

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