Objective of the Workshop: To strengthen the Regulatory system of India, it is required to improve the understanding and reviewing capacity of
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2 The workshop on Review of Stability Data submitted for Market Authorization was organized by Quality Assurance Division of CDSCO at Hotel Metropolitan, Bangla Sahib Road, New Delhi on 12 th -14 th February, 2014 to impart the knowledge on review of stability data to Officers of Central Drugs Standard Control Organization. Of the three days workshop, the first day of the workshop (i.e. 12 th February, 2014) was organized for the vaccine manufacturers, Deputy Drugs Controller (India), Assistant Drugs Controller (India), and Inspectors of Biological Division, Quality Assurance Division, participants from Central Drugs Laboratory (CDL), Kasauli, participants from National Institute of Biologicals (NIB), Noida who are involved in review of Module III of CTD submission. Therefore all the vaccine manufacturers were invited as participants and selected manufacturer delivered presentation on Stability Study. On 13 th & 14 th February, 2014, participants were the Drugs Inspectors from New Drugs, Medical Devices, Biologicals, QA Division along with Deputy Drugs Controller (India) and Assistant Drugs Controller (India) of concerned division. Presentations on stability was made by Dr. Saranjit Singh, Professor & Head, Pharmaceutical Analysis, NIPER on both days along with case study, group discussion and evaluation.
3 Objective of the Workshop: To strengthen the Regulatory system of India, it is required to improve the understanding and reviewing capacity of stability data of CDSCO and NCL reviewers because as per the requirements of Appendix IX of Schedule Y stability study is to be performed to provide evidence on how the quality of a drug substance or formulation varies with time under the influence of various environmental factors such as temperature, humidity and light, and to establish shelf life for the formulation and recommended storage conditions.
4 AGENDA OF THE WORKSHOP: 12 TH FEBRUARY, 2014 Time Topic Speaker 9:30-10:00 Registration - 10:00-10:30 Inaugural session (Welcome address, Introduction of participants) CDSCO 10:30 10:40 Introduction of the Workshop CDSCO 10:40 11:00 Tea Break 11:00-11:45 Stability Study Presentation Mr. Vikas Dogar (Serum Institute of India Ltd) 11:45 11:55 Discussion on presentation All Participants 11:55-12:40 Stability Study Presentation Mr. Gopal Singh (Panacea Biotech Ltd) 12:40 12:50 Discussion on presentation All Participants 12:50 13:50 Lunch Break 13:50 14:35 Stability Study Presentation Dr. Anandbabu/ Mr. Parag Nagarkar (Shantha Biotechnics Ltd.) 14.:35-14:45 Discussion on presentation All Participants 14:45 15:30 Stability Study Presentation Mr. Suresh (Biological E. Limited) 15:30 15:40 Discussion on presentation All Participants 15:40 16:00 Tea Break 16:00 16:45 Stability Study Presentation Mr D. Mahesh (Human Biologicals Limited) 16:45 16:55 Discussion on presentation All Participants 16:55 17:30 Views of Public Sector Units on Stability Study and Open House Discussion All Participants
5 AGENDA OF THE WORKSHOP: 13 TH FEBRUARY, 2014 Time Topic Speaker 9:30-10:00 Registration - 10:00-10:15 Inaugural session (Welcome address, Introduction of participants) CDSCO 10:15-10:25 Introduction of the Workshop CDSCO 10:25 10:45 Pre-assessment CDSCO 10:45 11:00 Tea Break 11:00-13:00 WHO STABILITY STUDIES GUIDELINES 13:00 13:50 Lunch Break 13:50 15:40 WHO Stability Studies Guidelines 15:40 16:00 Tea Break 16:00 17:00 WHO Stability Studies Guidelines Dr. Saranjit Singh (NIPER) Dr. Saranjit Singh (NIPER) Dr. Saranjit Singh (NIPER) 17:00 18:00 Discussion on presentation All Participants 9:30-10:00 Registration - 10:00-10:15 Inaugural session (Welcome address, Introduction of participants) CDSCO 10:15-10:25 Introduction of the Workshop CDSCO 10:25 10:45 Pre-assessment CDSCO 10:45 11:00 Tea Break 11:00-13:00 WHO STABILITY STUDIES GUIDELINES Dr. Saranjit Singh (NIPER)
6 AGENDA OF THE WORKSHOP: 14 TH FEBRUARY, 2014 Time Topic Speaker 10:00-10:40 ICH (Q1A to Q1E) Stability Studies Guidelines 10:40 11:00 Tea Break 11:00-13:00 ICH (Q1A TO Q1E) Stability Studies Guidelines 13:00 13:50 Lunch Break 13:50 15:40 ICH (Q1A to Q1E) Stability Studies Guidelines 15:40 16:00 Tea Break Dr. Saranjit Singh (NIPER) Dr. Saranjit Singh (NIPER) Dr. Saranjit Singh (NIPER 16:00 17:30 Case Studies and Discussion on presentation All Participants 17:30 18:00 Post-assessment CDSCO 10:00-10:40 ICH (Q1A to Q1E) Stability Studies Guidelines 10:40 11:00 Tea Break 11:00-13:00 ICH (Q1A TO Q1E) Stability Studies Guidelines 13:00 13:50 Lunch Break 13:50 15:40 ICH (Q1A to Q1E) Stability Studies Guidelines 15:40 16:00 Tea Break Dr. Saranjit Singh (NIPER) Dr. Saranjit Singh (NIPER) Dr. Saranjit Singh (NIPER 16:00 17:30 Case Studies and Discussion on presentation All Participants 17:30 18:00 Post-assessment CDSCO 10:00-10:40 ICH (Q1A to Q1E) Stability Studies Guidelines Dr. Saranjit Singh (NIPER)
7 List of Participants on 12 February, 2014 Sr. No. Name of the Participant Office Address Designation Dr. Saranjit Singh Mr. S.P. Shani NIPER CDSCO (EZ) Professor & Head, Pharmaceutical Analysis, NIPER Deputy Drugs Controller (India) 3. Dr. A. Ramkishan CDSCO(QA) Deputy Drugs Controller (India) Ms. Rubina Bose Dr. Inderjeet Singh Hura CDSCO (HQ) CDSCO (HQ) Assistant Drugs Controller (India) Assistant Drugs Controller (India) 6. Mr. Jayant Gangakhedkar CDSCO (HQ) Assistant Drugs Controller (India) 7. Mr. Sourabh Mittal CDSCO (HQ) Drugs Inspector 8. Mr. Devendra Nath CDSCO (HQ) Drugs Inspector 9. Mr. Rakesh Negi CDSCO (HQ) Drugs Inspector
8 List of Participants on 12 February, 2014 Sr. No. Name of the Participant Office Address Designation Mr. Amol Eknath Kandekar CDSCO (HQ) Drugs Inspector Mr. Saurabh Garg CDSCO (HQ) Drugs Inspector Mr. Rajesh Kumar Verma CDSCO (HQ) Drugs Inspector Mr. Shashi Paul CDSCO (HQ) Drugs Inspector Mr. Vinod Kumar CDSCO (HQ) Drugs Inspector Mr. Ankur Bansal CDSCO (HQ) Drugs Inspector 17 Mr. Fahim Khan CDSCO (HQ) Drugs Inspector Mr. Rahul Panwar CDSCO (HQ) Drugs Inspector Mr. Yogesh Shelar CDSCO (HQ) Drugs Inspector
9 List of Participants on 12 February, 2014 Sr. No. Name of the Participant Office Address Designation Ms. Shraddha Srivastava CDSCO (HQ) Drugs Inspector Mr. Manish Singhal CDSCO (HQ) Drugs Inspector Mr. Vinay Kumar Gupta CDSCO (HQ) Drugs Inspector Dr. Sikha Yadav NIB Scientist Grade-II Dr. Renu Jain NIB Scientist Grade-II Smt. Gurminder Bindra NIB Scientist Grade-III 26 Mr. Sunil Kumar Goel CDL Technical Officer Mr. Vivek Bansal CDL Technical Supervisor Mr. Devinder Kumar CDL Technical Supervisor
10 List of Participants on 12 February, 2014 Sr. No. Name of the Participant Office Address Designation Mr. Devendra Barthwal CDL Technical Supervisor Mr. Sachin Sood CDL Technical Supervisor Mr D. Mahesh Human Biologicals Limited ---- Mr. Vikas Dogar Serum Institute of India Ltd Mrs. Vidya A Sawakhande Haffkine Biopharmaceutical Corporation Ltd Mrs. Sheron S. Borkar Haffkine Biopharmaceutical Corporation Ltd. Manager,QA 35 Mr. Sanjay Maheshwari Cadila Healthcare Limited Mr. Prabhakar Rao Chiron Behring Vaccine Ltd ---- Mr. Suresh Biological E. Limited ----
11 List of Participants on 12 February, 2014 Sr. No. Name of the Participant Office Address Designation Mr. Madan Mohan Biological E. Limited ---- Dr. Sunil Kumar CRI, Kasauli ---- Dr. Yashwant Kumar CRI, Kasauli ---- Mr. C.Palaniappan Pasteur Institute ---- Dr. T. F. Hassan BCG Vaccine laboratory, Guindy Mr. Gopal Singh Panacea Biotech Ltd Dr. Shweta Gupta Bharat Immunological & Biologicals Corporation Limited ---- Dr. Kankalpati Anil Kumar Ranbaxy Laboratories Limited ---- Ajay Kumar --- Manager, QA
12 List of Participants on 12 February, 2014 Sr. No. Name of the Participant Office Address Designation Sashnita. S Biomed Pvt. Ltd Quality Maneger Sanjay Diwedi Pancea Biotech Ltd Assistant General Manager Sanjay Kumar Cadila Healthcare Ltd. Sr. Supervisor
13 List of Participants on February, 2014 Sr. No. Name of the Participant Office Address Designation 1 2 Dr. Saranjit Singh Mr. S.P. Shani NIPER CDSCO (EZ) Professor & Head, Pharmaceutical Analysis, NIPER Deputy Drugs Controller (India) 3 4 Dr. A. Ramkishan Ms. Rubina Bose CDSCO(QA) CDSCO (HQ) Deputy Drugs Controller (India) Assistant Drugs Controller (India) 5 Mr. Sanjeev Kumar CDSCO (HQ) Assistant Drugs Controller (India) 6 Mr. Jayant Gangakhedkar CDSCO (HQ) Assistant Drugs Controller (India) 7 Mr. Sourabh Mittal CDSCO (HQ) Drugs Inspector 8 9 Mr. Devendra Nath CDSCO (HQ) Drugs Inspector Mr. Rakesh Negi CDSCO (HQ) Drugs Inspector
14 List of Participants on February, 2014 Sr. No. Name of the Participant Office Address Designation Mr. Amol Eknath Kandekar CDSCO (HQ) Drugs Inspector Mr. Saurabh Garg CDSCO (HQ) Drugs Inspector Mr. Rajesh Kumar Verma CDSCO (HQ) Drugs Inspector Mr. Shashi Paul CDSCO (HQ) Drugs Inspector Mr. Vinod Kumar CDSCO (HQ) Drugs Inspector Mr. Ankur Bansal CDSCO (HQ) Drugs Inspector 16 Mr. Fahim Khan CDSCO (HQ) Drugs Inspector Mr. Rahul Panwar CDSCO (HQ) Drugs Inspector Mr. Yogesh Shelar CDSCO (HQ) Drugs Inspector
15 List of Participants on February, 2014 Sr. No. Name of the Participant Office Address Designation Ms. Shraddha Srivastava CDSCO (HQ) Drugs Inspector Mr. Surender Kumar Kaswan CDSCO (HQ) Drugs Inspector Mr. Sandeep Kumar CDSCO (HQ) Drugs Inspector Mr. Jay Jyoti Roy CDSCO (HQ) Drugs Inspector Ms. Sunitha Seerapu CDSCO (HQ) Drugs Inspector Mr. Manoj Choudhary Jatav CDSCO (HQ) Drugs Inspector 25 Mr. Pratyush Kumar CDSCO (HQ) Drugs Inspector Mr. Sri Babu CDSCO (HQ) Drugs Inspector Mr. Sushanta Sarkar CDSCO (HQ) Drugs Inspector
16 List of Participants on February, 2014 Sr. No. Name of the Participant Office Address Designation Ms. C.Thiruvidha CDSCO (HQ) Drugs Inspector Mr. Balakumar Mahalingam CDSCO (HQ) Drugs Inspector Dr. Bikash Roy CDSCO (HQ) Drugs Inspector Mr. S. John Gerard CDSCO (HQ) Drugs Inspector Mr. Haribabu J CDSCO (HQ) Drugs Inspector Ms. Suniti Choudhary CDSCO (HQ) Drugs Inspector 34 Mr. Parthiban J CDSCO (HQ) Drugs Inspector Mr. Manish Horo CDSCO (HQ) Drugs Inspector Mr. Basant Kumar Yadav CDSCO (HQ) Drugs Inspector
17 List of Participants on February, 2014 Sr. No. Name of the Participant Office Address Designation Dr. Vijai Singh Karwasara CDSCO (HQ) Drugs Inspector Mr. Hemant Madhukar Patil CDSCO (HQ) Drugs Inspector Mr. Arvind Singh Panwar CDSCO (HQ) Drugs Inspector Mr. Bidya Sekhar Mishra CDSCO (HQ) Drugs Inspector Ms. Sudarmathi S CDSCO (HQ) Drugs Inspector Ms. A Anbuselvi CDSCO (HQ) Drugs Inspector 43 Mr. Dinesh Kumar CDSCO (HQ) Drugs Inspector 44 Ms. Kiran Singh CDSCO (HQ) Drugs Inspector
18
19 ON FIRST DAY, MR. S.P. SHANI, DEPUTY DRUGS CONTROLLER (INDIA), CDSCO HIGHLIGHTED TO ALL THE PARTICIPANTS FOR THE NEED OF STABILITY AND ADDRESSED VARIOUS ISSUES
20 DR. A. Ramkishan, Deputy Drugs Controller (India), CDSCO addressed the importance of this workshop and highlighted the mandate, mission and vision of CDSCO, objective and expectation from this workshop.
21 PRE-ASSESSMENT OF THE PARTICIPANTS AT THE BEGINNING OF THE
22 PRESENTATIONS ON STABILITY STUDIES BY DIFFERENT PHARMACEUTICAL MANUFACTURERS
23 Presentations on Stability studies by different vaccine manufacturers
24 FACILITATORS AND PARTICIPANTS TAKING KEEN INTEREST
25 THE REVIEW OF STABILITY DATA WAS MADE MORE SIMPLIFY WITH THE ENLIGHTENMENT BY MR. S.P. SHANI, DEPUTY DRUGS
26 WHO stability Guideline and various ICH guidelines were discussed by Mr. Saranjit Singh, Professor & Head, Pharmaceutical Analysis,
27 ON BOTH DAYS, DR. SARANJIT SINGH DISCUSSED VARIOUS STABILITY PROBLEMS, CASE STUDIES ON STABILITY OF DRUGS SUBSTANCES AND PRODUCTS WITH THE PARTICIPANTS IN REGULATORY PERSPECTIVE.
28 ROUP DISCUSSION ON CASE STUDY
29 POST ASSESSMENT
30 Participants for workshop
31 Outcomes of workshop: Detailed discussion on WHO and ICH stability study guidelines imparted knowledge to the participants on the stability requirements during regulatory submission of stability data and was useful for the participants to access the regulatory submission and to take appropriate decision.
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