Indian Pharmaceutical Association - Industrial Pharmacy Division
National Workshop
“ EMERGING TRENDS IN PHARMACEUTICAL QUALITY SYSTEMS“
l Pharmaceutical Quality Systems l Good Documentation Practices l Validation of Analytical Methods
Indian Pharmaceutical Association - Industrial Pharmacy
Division ( IPA IPD ) organized a one day National Workshop on
“ Emerging Trends in Pharmaceutical Quality Systems”
on Friday, 18th January 2008 at Bangalore as well as at Chandigarh
on 20th January 2008 in collaboration with SGS & in co-
ordination with IPA - Education Division & University
Institute of Pharmaceutical Sciences, Punjab University,
Chandigarh respectively.
The Technical Experts mainly from Manufacturing, Quality
Assurance, Quality Control and R&D departments of various
Pharma Industries from Bangalore, Hosur, Hyderabad, Goa,
Chennai, Mumbai, Ahmedabad, Vadora, Delhi and Baddi
attended the National Workshop besides academicians and
research scholars.
Mr. Kaushik Desai,
Vice Chairman, IPA IPD
in his welcome address
both at Bangalore and
Chandigarh informed the
delegates from Pharma
industry and the academia
that it is the second time
that IPA-IPD is organizing a workshop in collaboration with
SGS, Switzerland as a part of continuous education program
and first time at Bangalore & Chandigarh.
While briefing about global pharma industrial scenario, Mr.
Desai said that the life of a professional working in Industry is
becoming more & more difficult & challenging because of ever
changing requirements.
It is IPA-IPD's significant & relentless effort towards this
initiative to educate the Pharma Professionals on the current
trends in the Quality Systems, Good Documentation Practices,
Validation of Analytical Methods and updating them with the
global regulatory developments. IPA-IPD has been always in
forefront in imparting knowledge by organizing such
workshops, symposia in various parts of the country. Mr.
Kaushik conveyed the greetings to all delegates from Mr. J.A.S.
Giri, Chairman, IPA-IPD & Prof. K. Chinna Swamy, Chairman,
IPA -Education Divison.
Dr. B. Prabha Shankar,
S e c r e t a r y, I PA - I P D
briefed the delegates
about the aims and
objectives of the IPA,
Industrial Phar macy
Division which has been
playing a role of an
ambassador of Pharma Industry in India and working together
in co-ordination with like minded organizations like SGS,
Pharmexcil, Indian Pharmaceutical Alliance, BDMA, IDMA,
OPPI, FICCI and CII. He said the team of IPD has successfully
organized in the last two years five events in various parts of the
country and with this national workshop, they will be
completing seven national events in their two-year term. The
First event, which was organized, was International Workshop
on “Compliance in New and Generic Clinical Drug
Development” in 2006 followed by the Indo-US Interactive
Seminars in three cities - Hyderabad, Mumbai and Ahmedabad
on 24th, 26th and 28th March 2007 respectively on the topic “
Preparing for USFDA and How to face US FDA Inspection and
Recent Trends in Stability Studies” in collaboration with SGS.
Recently, IPA-IPD had organized one more national seminar at
Hyderabad on 22nd December 2007 on the burning topic of “
Plastic Hazards in Pharma and Consumer Industry and what are
the Alternatives to Plastics”.
He further added that, this workshop is designed to provide
some high level guidelines on designing a harmonized
pharmaceutical quality system applicable across the life cycle of
the product. It will refer the integrated approach described on
ICH Q8, Q9 and Q10. The workshop provides the
fundamentals on Good Documentation Practices, practical tips
on different types of documents in the manufacturing
operations and the recent regulatory observations on poor
documentation. Dr. B. Prabha Shankar informed that the expert
on Validation of Analytical Methods and Method Transfers
would cover the existing guidelines for the validation of
analytical methods, which include practical examples of various
successful method transfers and discuss differences regarding
the respective scope of work.
Dr. Mr s. Meena
Kumari, Key Account
Manager- India Africa &
Middle East, SGS Life
Science, Services
introduced SGS & the
global functioning of
SGS Life Sciences. SGS is
the world's leading inspection, verification, testing and
certification company. With 49000 employees, SGS operates a
network of about 840 offices and 320 laboratories around the
world. Originally founded in 1878 in Rouen as French grain
shipment inspection house, the Company was registered in
Geneva as Société Générale de Surveillance in 1919. The
facilities are available at US, Canada, Belgium, Germany, France
and recently expanded into many Asian countries with main
facilities at India & Singapore. SGS in India started during 1950,
having the headquarters at Mumbai operates a wide network of
laboratories and offices to cater the needs of all industries and
sectors like agriculture, food, phar maceutical and
environmental, textiles, leather, garments, etc SGS INDIA has
entered into exclusive Life Science Services business in Feb.
2005, it is fully operational from a specialized bio park at TICEL,
Chennai and well equipped with experienced personnel and with
the high-quality sophisticated instruments like LC-MS-MS, ICP-
MS, GC-MS-MS, Real Time PCR, Cell culture, and other
commonly required pharmaceutical testing instruments.
Prof. T.V.Narayana,
Secretary, IPA Education
Division briefed the
delegates at Bangalore
about aims and objectives
about IPA Education
Division and also
informed the delegates
about activities carried in the last two years. He expressed his
happiness for associating with IPA - IPD in organizing this
event, which is equally attended by the Pharma Professionals
from Industry and Academia. He gave a brief introduction of
the expert speakers Dr. Angela Moy, Director of Global Quality
Assurance, SGS Life Science Services Division, Canada and Mr.
Ulrich Markens, Site Manager, SGS, Life Sciences, Singapore.
Prof. A Raghuram Rao,
gave brief idea to the
delegates at Chandigarh
about the achievements
of University Institute of
Pharmaceutical Sciences,
P u n j a b U n i v e r s i t y,
Chandigarh, and the
facilities available in their Institute for carrying out Research and
Development activities for Pharma Industries. He stated that
his Institution has successfully developed and transferred
technology of three products, which are today commercialized
by Pharma Industries in India. The department earlier
developed an NCE, Chandonium Iodide, whose rights are
currently held by Cipla Ltd. He invited the Pharma Industry to
utilize their facilities and expertise for collaborative research.
He further informed that the University Institute of
Pharmaceutical Sciences would like to coordinate with IPA
IPD in future workshops conducted at Chandigarh.
Design of Pharmaceutical Quality System :
Dr. Angela Moy, Global
QA Manager of SGS,
Canada, in her
presentation on design of
pharmaceutical quality
system expressed that
U.S. FDA and many other
regulators from other
countries have initiated a
risk based inspection approach on quality systems. There is no
one-size-fits-all approach on quality systems. We need to know
our products and our processes well in order to design the most
effective and most efficient quality systems. ICH Q10
demonstrates industry and regulatory authorities' support of an
effective pharmaceutical quality system to enhance the quality
and availability of medicines around the world. Implementation
of an effective, efficient and compliant quality system
throughout the product lifecycle should facilitate innovation and
continual improvement and strengthen the link between
pharmaceutical development and manufacturing activities.
According to Dr. Moy, every Pharma manufacturing processes
should be effective and efficient to ensure product quality and
performance through continuous improvement of processes,
which are monitored by having “real time” assurance of product
quality. Management-based regulation, coupled with regulatory
guidance and inspectional oversight provides the foundation for
the 'Desired State” GMP + GBP (good business practices) +
Robust Quality System. A harmonized pharmaceutical quality
system applicable across the life cycle of the product
emphasizing an integrated approach to quality risk management
and science should follow the new ICH tripartite guideline
(Q8.Q9.Q10) which simplifies regulatory implementation of
FDA's Initiative and thus serves as a bridge between different
regional regulations and thereby helps to achieve global
harmonization of quality systems.
Good Documentation Practices:
Dr.Angela Moy in her presentation on good documentation
practices said in the highly regulated pharmaceutical industry, we
need to produce high quality drug products as well as high
quality documents. All documents associated with drug
products from development, registration, validation,
manufacturing, quality control, distribution and post approval
quality assurance are required to meet the GMP standards.
Especially true in the manufacturing operations, if it's not
documented, it's a rumour. We are trained to document almost
everything. She asked the audience whether they are confident
of documenting effectively and efficiently? What and who needs
to be documented? How to ensure traceability in our
documentation? She spoke about the fundamentals of good
documentation practices, giving several examples and how they
can be linked and traceable, and poor documentation practices
which are cited by regulators. Dr. Moy summarized her
presentation by saying that, a good manufacturing process
coupled with good documentation practice in pharmaceutical
manufacturing can reduce number of manufacturing
supplements and submissions, reward application of prior
knowledge and risk-based approaches, establish the foundation
of Quality by Design, demonstrate the long-term reward of
investing in manufacturing science of operations.

clarified the queries and gave suggestions and advices to the

Validation of Analytical Methods / delegates on the various issues related to Design of
Method Transfers: Pharmaceutical Quality System, Good Documentation
Practices and Validation of Analytical Methods / Method
Mr.Ulrich Markens, Transfers.
Head of Asian
O p e r a t i o n s, S G S, Dr. D. N. Dixit, Vice
Singapore in his President, Quality
presentation said there Assurance, Nicolas
isa worldwide trend in Piramal Ltd., Baddi
the phar maceutical addressed on behalf of
industr y towards the delegates at
reorganization and Chandigarh and
relocation of facilities, transfer of products or product lines congratulated IPA-IPD
from one manufacturing site to another, and increasing for organizing the
outsourcing activities. In this context, the transfer of analytical National Workshop for the first time at Chandigarh, specially for
methods is gaining more and more importance. Unlike the the Pharma Industry Professionals working in and around
validation of analytical methods, there are no guidelines Baddi. He requested IPA-IPD to organize many such
available for the transfer of methods. Here it is up to the Continuing Educational Programs and promised to provide
pharmaceutical company to define a framework in a so-called support.
'Method Transfer Protocol" and record the successful
conclusion of a transfer in a "Method Transfer Report”. Since a Mr. M. Vasudev Rao,
method transfer mostly includes revalidation work, the issues of Executive Council
analytical method transfer and analytical method validation are M e m b e r o f I PA -
inseparably linked. Industrial Phar macy
Division played a key role
at Chandigarh in getting
maximum participants
from Baddi to attend the
workshop and proposed a vote of thanks.

Mr. Nagarjuna Reddy, Executive

Council Member IPA Education
Division Co-ordinated in Making
He sighted some examples of successful analytical method local arrangements and motivated
transfers like, transfer without revalidation, transfer with minor M. Pharm students to attend the
revalidation effort & transfer with complex revalidation effort. workshop at Bangalore. and
Before starting the transfer, following things are necessary to be thanked Dr. V. Satyanarayana,
followed: Ensure that the method you plan to transfer is robust, Treasurer IPA IPD for attending the Workshop at Bangalore.
define all critical points in procedure, bring all involved persons
together (face-to-face meeting), ensure that reference materials
are available, ensure that all necessary information is transferred
in advance and write a comprehensive Transfer Protocol. After
finishing the transfer, review all documents, write Transfer
Report and then Receiving Lab is qualified to test samples and
the Method is transferred successfully.

The Delegates at Bangalore and Chandigarh actively

participated in the interactive session where the guest speakers