Indian Pharmaceutical Association - Industrial Pharmacy Division

National Workshop

EMERGING TRENDS IN PHARMACEUTICAL QUALITY SYSTEMS

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Pharmaceutical Quality Systems

Good Documentation Practices l Validation of Analytical Methods

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

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 coordination 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.

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 Socit Gnrale 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, ICPMS, 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.

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

Design of Pharmaceutical Quality System :

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.

Validation of Analytical Methods / Method Transfers:

Mr.Ulrich Markens, Head of Asian O p e r a t i o n s, S G S, Singapore in his presentation said there isa worldwide trend in the phar maceutical industr y towards reorganization and relocation of facilities, transfer of products or product lines from one manufacturing site to another, and increasing outsourcing activities. In this context, the transfer of analytical methods is gaining more and more importance. Unlike the validation of analytical methods, there are no guidelines available for the transfer of methods. Here it is up to the pharmaceutical company to define a framework in a so-called 'Method Transfer Protocol" and record the successful conclusion of a transfer in a "Method Transfer Report. Since a method transfer mostly includes revalidation work, the issues of analytical method transfer and analytical method validation are inseparably linked.

clarified the queries and gave suggestions and advices to the delegates on the various issues related to Design of Pharmaceutical Quality System, Good Documentation Practices and Validation of Analytical Methods / Method Transfers. Dr. D. N. Dixit, Vice President, Quality Assurance, Nicolas Piramal Ltd., Baddi addressed on behalf of the delegates at Chandigarh and congratulated IPA-IPD for organizing the National Workshop for the first time at Chandigarh, specially for the Pharma Industry Professionals working in and around Baddi. He requested IPA-IPD to organize many such Continuing Educational Programs and promised to provide support. Mr. M. Vasudev Rao, Executive Council M e m b e r o f I PA 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 local arrangements and motivated M. Pharm students to attend the workshop at Bangalore. and thanked Dr. V. Satyanarayana, Treasurer IPA IPD for attending the Workshop at Bangalore.

He sighted some examples of successful analytical method transfers like, transfer without revalidation, transfer with minor revalidation effort & transfer with complex revalidation effort. Before starting the transfer, following things are necessary to be followed: Ensure that the method you plan to transfer is robust, 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