NIPER had successfully conducted 53 training programs under the World Bank sponsored “Capacity Building Project” in the years 2004 to 2008, for the technical staff from government testing laboratories, regulatory bodies, private testing laboratories and analytical as well as production staff from Small and Medium Pharmaceutical Industries (SMPIs). Department of Pharmaceuticals, Government of India, announced the setting up of a dedicated centre for SMPIs at Pharmaceutical Advisory Forum (PAF) on 23rd April 2008. This Centre offers practical trainings on analytical instruments and conducts seminars on issues of relevance to the Pharma industry like GLP, GMP & regulatory affairs. All these activities have been designed in consultation with SMPIs. This dedicated centre aims at creating synergy between industry and academia.
Good Laboratory Practice (GLP) - is to ensure the generation of high quality and reliable test data. GLP embodies a set of principles that provide a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These practices ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of pharmaceutical products. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments. GLP principles keep a check on Organization, Quality Assurance program, Equipment, Reagents, Materials, Test & Reference items, Standard operating procedures, Reporting of results, Storage of Records and Reports.
Good Manufacturing Practice (GMP) - is a system for ensuring that products are consistently produced according to quality standards. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures have been followed at each step in the manufacturing process, each time a product is manufactured. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures and create their own GMP guidelines. Basic philosophy of all these guidelines is to safeguard the health of the patient by producing good quality medicines, medical devices or active pharmaceutical products. Indian Pharmaceutical Industry is one of the largest and most advanced among the developing countries. It has over the years made significant progress in infrastructure development and technological capability. Understanding the regulatory perspective in this sector is extremely crucial not only due to ever evolving changes in the area of GLP and GMP, but also due to the onus on the regulatory bodies to ensure a supply of quality drugs at affordable prices to the Indian masses. Keeping in pace with the international regulatory scenario, the Indian pharmaceutical regulatory bodies have also come out with major changes and have published GLP and GMP guidelines.
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This seminar shall focus on various aspects of both GLP and GMP guidelines. The seminar is intended for the personnel from the industry and researchers within the academic community. The following are some of the topics that shall be deliberated in the seminar-
1. GLP Practices
2. GLP as per Schedule L1
3. GMP in Pharmaceutical Industry
4. Implementation of Schedule M
5. Understanding standards of drugs as defined and prescribed under Drugs and Cosmetics Act 1940 and Rules there under
Registration Fee
Rs 3000 /- per delegate, Rs 2000/- for SMPIC members and Rs 800/- for students.
The fee includes course material in the form of CD, lunch, refreshments, tea /coffee and excludes accommodation charges.
On site Registration
The on-site registration desk will be open on the day of seminar from 8.00 to 10.00am. An additional fee of Rs 500/- will be charged for on-site registration.
The last date for Registration is 22nd December, 2013
An extra Rs. 500/- for on-site Registration
*Students are required to attach id Proof DD in favour of Director, NIPER, Payable at Mohali should be sent along with dully filled form.
National Institute of Pharmaceutical Education and Research (NIPER)
Sector 67, Near PCA Stadium, S.A.S. Nagar - 160 062, Punjab (Block G, Room no. 106)
Email: smpic@niper.ac.in
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