GLP are recognized governing the conduct non clinical safety studies ensuring the quality, integrity and reliability of their data.

Transcription

1 One day National Seminar On Good Laboratory Practices held in Bangalore by IPS (KAB) and IPA IPD Report : Y. Veeranarayana Gowda Secretary - IPA Karnataka State Branch We, the Indian Pharmaceutical Association, Karnataka State Branch and IPA Industrial Pharmacy Division in association with Karnataka Drugs & Pharmaceuticals Manufacturers Association (KDPMA) & North Karnataka Drugs & Pharmaceuticals Manufacturers Welfare Association (NKD & PMWA) organised one day National Seminar on GOOD LABORATORY PRACTICES on 4 th September 2010 from morning 9.30 A.M. to 6.30 P.M deliberate on GLP. Topics such as How Schedule L1 impacts you, instruments & equipment calibration, microbiological testing and internal audit were covered during the day long deliberation. Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory has to function in pharmaceutical industry and public testing laboratories. The Government of India has notified GLP pertaining to Drugs & Pharmaceuticals under the Provisions of the Drugs and Cosmetics Act, 1940 as Schedule L-I vide Gazettee notification No. 780(E) dated which is going to be effective from GLP are recognized governing the conduct non clinical safety studies ensuring the quality, integrity and reliability of their data. India is one of the first countries to include GLP for laboratories involved in testing of pharmaceuticals. While implementation of this schedule in small scale and tiny scale sectors may pose initial difficulties, the implementation would ultimately benefit both the manufacturers & the patients as this would lead to reduction in rejection of batches and zero defect product reaches the customers. Schedule L1covers following aspects: Premises: Design of laboratory, Equipment, Good housekeeping and safety Maintenance, calibration, and validation of equipments:- Quality system, Internal quality system audits and Management review Knowledge of Good Laboratory Practices is very important in Pharmaceutical Industry and Public Testing laboratories as well as govt testing labs. 1

2 The seminar was inaugurated by Shri I.M.Vittal Murthy IAS Secretary Medical Education Government of Karnataka. Dr Ramana Reddy IAS Secretary Health and Family Welfare was the Guest of Honor. Dr.B.R.Jagashetty Drugs controller for the state of Karnataka and President IPA(KSB) was present. The program began with an introduction by Dr Premnath Shenoy Vice President IPA (KSB) regarding IPA & the GLP seminar. Shri Kaushik Desai Chairman IPA IPD made the welcome address. Dr B.R.Jagashetty, President IPA & Drugs controller for the state of Karnataka addressed the gathering on objective of organizing this seminar. Mr Anjan Roy president KDPMA spoke briefly on contribution made by pharmaceutical companies in Karnataka in the field of pharmaceuticals. The guest of Honor, Dr Ramana Reddy IAS urged the industry captains to ensure quality and make medicines available at affordable cost. Dr Reddy assured the industry that Government would work towards improving the climate for pharmaceutical business in the state. Shri I.M. Vittal Murthy IAS congratulated IPA for conducting scientific seminar and appreciated the delegates for attending in large numbers. Inauguration ended with vote of thanks by Mr. Ramana Gowdar G.R. Deputy Drugs Controller of Karnataka Followed with Five sessions were held during the day long deliberations. Session one was chaired by Shri Kaushik Desai. The speaker Shri Kapil Bhargava, Retired Dy Drugs Controller CDSCO addressed the gathering on the topic Schedule L1 - How it may impact you? He highlighted certain areas in the schedule that needs to be addressed in order to provide clarity for implementation. The second session was chaired by Dr Premnath Shenoy. The speaker Shri Sanjay Shetgar Senior Director Quality DRL spoke on the topic - Internal Audits & Common audit observations in laboratories. He covered areas such as why audit, typical observations during laboratory audits, warning letter in the area of laboratory inspections and so on. Session three was chaired by Shri V.L.Hamber Deputy Drug s controller. Mr Umesh B.G sr general manager Stempeutics spoke on the topic Microbiological testing. He covered Why Microbiology testing, Schedule L1 requirement, Personnel Monitoring, EM monitoring, RM/PM, in process and finished product testing and OOS in Microbiological testing. Session four was chaired by Shri A.R.Hegde : Dr Elango Minnoor Senior Manager QC, Biocon spoke on Equipment & Instruments calibration. He covered instrument procurement and life cycle, instrument qualification and instrument calibration. 2

3 Session five was a lively Panel discussion Panelists included Dr B.R.Jagashetty Drugs Controller for the state of Karnataka, Shri Shetgar, Mr. Umesh, Mr.AR Hegde former MD Astra-IDL, Mr Jatish Sheth Secretary KDPMA. The panel discussion was moderated by Dr Premnath Shenoy. The seminar ended with good interaction informative professionalized panel discussion was conducted along with Dr. B R Jagashetty, Dr. Sanjay Shegar, Shri Umesh B.G. Dr. Elango Minnoor, Shri A.R. Hegde, Jatish N Sheth, Shri Chauvan ADC (Ind.) & Moderator Dr. K.R.P. Shenoy Y. Veeranarayana Gowda Secretary IPA Karnataka State Branch thanked the participate and the other association office bearers and over all supported the organising the seminar also called for feedback of the programme There were about 250 delegates from industry, lab and regulatory are attended. The seminar is conducted professionally. There were good interactions between the speakers and professionals, and they exchanged their knowledge and clarified the act and it modalities. Good Laboratory Practices Seminar inauguration function photos From Left to Right (1) K.R.P.Shenoy, Co-ordinator (2) Ramananda Hegde President, NKD & PMWA, (3) Kaushik Desai, Vice President, IPA (HQ), (4) Dr. E.V. Ramana Reddy, IAS, Secretary for Health & Family Welfares, Govt. of Karnataka, (5) Sri. I.M. Vittal Murthy, IAS, Secretary for Medical Education, Govt. of Karnataka, (6) Dr. B.R. Jagashetty, Drugs Controller of Karnataka. (7) Anjan K. Roy, President, KDPMA, (8) Y.Veeranarayana Gowda, Secretary, IPA., 3

4 Welcome Speech by Kaushik Desai 4

5 Y. Veeranarayana Gowda - Secretary IPA Jatish N Seth - Secretary KDPMA 5