THAILAND PIC/S ACCESSION: JOURNEY TOWARDS THE 49 TH PIC/S PARTICIPATING AUTHORITY. Suchart Chongprasert, Ph.D. Food and Drug Administration Thailand

Transcription

1 THAILAND PIC/S ACCESSION: JOURNEY TOWARDS THE 49 TH PIC/S PARTICIPATING AUTHORITY 20 Mar Aug 2016 Suchart Chongprasert, Ph.D. Food and Drug Administration Thailand

2 CONTENTS Historical Evolution of GMP Inspections in Thailand Journey Towards PIC/S membership On Becoming PIC/S PA: Key Lesson Learned Challenges Ahead Connecting Pharmaceutical Knowledge ispe.org

3 Historical Evolution of GMP Inspections in Thailand 1986 Encourage Modern Medicine manufacturers (MM) to implement WHO GMP on voluntary basis st Implementation of GMP inspections for MM under Public Health Ministerial Notification following WHO GMP 1992 Oct 2012 Full Implementation of GMP inspections for MM under Public Health Ministerial Notification following PIC/S guideline PE

4 Historical Evolution of GMP Inspection in Thailand (Cont.) Jun 2013 Applied for ASEAN Listed Inspection Service to prove for PIC/S GMP Conformance via Panel of Experts (Limited scope for Finished MM Pharmaceutical Dosage Forms only) Feb st Implementation of GMP inspections for Traditional Medicine manufacturers (TM) under Public Health Ministerial Notification following PIC/S guideline PE Mar 2015 Acceding to become 4 th ASEAN Listed Inspection Service 4

5 Historical Evolution of GMP Inspection in Thailand (Cont.) Mar 2015 Mar 2016 May Jul Aug 2016 Official submission of application through PIC/S accession procedure PIC/S On-site assessment New Public Health Ministerial Notification to Implement PIC/S GMP Guides PE PIC/S Committee invited Thai FDA to join the scheme as PIC/S 49 th Participating Authority (PA) Officially became 49 th PIC/S s PA 5

6 24 Feb 2006 May st Round Application February Submission of application Paper Assessment Jan 2008 On-site Assessment based on 89 indicators Findings: 29 deficiencies Critical deficiencies =5 Major deficiencies =18 Minor deficiencies = 6 31 Jul Jan Oct Feb 2012 Feb 2012 Submission of CAPA Submission of CAPA Submission of progress report Submission of progress report Termination of application

7 PIC/S Assessment Team: 1 st Application PIC/S Assessment Team Affiliation Mr. Jacques Morénas, Rapporteur Ms. Kadariah Mohd Ali, Co-rapporteur Mr. Boon Meow Hoe, Co-rapporteur Mr. Paul Sexton, Co-rapporteur Mr. André Kovacs, Co-rapporteur AFSSAPS/France NPCB / Malaysia HSA / Singapore IMB / Ireland PIC/S Secretariat

8 2 nd Round Application 20 March 2015 PIC/S Paper Assessment Connecting Pharmaceutical Knowledge ispe.org

9 PIC/S Assessment Team: 2 nd Round PIC/S Assessment Team Affiliation Mr. Jacques Morénas, Rapporteur Mr. Boon Meow Hoe, Co-rapporteur Ms. Gaye Camm, Co-rapporteur Ms. Shanti Marlina, Co-rapporteur AFSSAPS/France HSA/ Singapore TGA/ Australia NADFC/ Indonesia

10 PIC/S On-site Assessment Opening Meeting 14 March 2016 Connecting Pharmaceutical Knowledge ispe.org

11 PIC/S On-site Assessment Closing Meeting: 18 March 2016 Connecting Pharmaceutical Knowledge ispe.org

12 Cheerful Group Picture Connecting Pharmaceutical Knowledge ispe.org

13 Outcome of On-site assessment PIC/S requirements (78 indicators) Fully fulfilled Fully fulfilled with condition Partially fulfilled 73 indicators 3 indicators 2 indicators

14 Indicator # Outcome of On-site assessment PIC/S requirements Fully fulfilled with condition Partially fulfilled 11 X 29 X when implemented 69 X subject to receiving new SOP Recall and rapid alert system 73 X subject to receiving new QM 76 X

15 Journey towards PIC/S Membership

16 Journey towards PIC/S Membership (cont.)

17 PIC/S Accession Letter of Thai FDA

18 Journey towards PIC/S Membership Connecting Pharmaceutical Knowledge ispe.org

19 On becoming PIC/S PA: Key Lessons Learned Political Will & Commitment from Senior Management Quality System in Place Determination of Team Thai FDA

20 Challenge ahead : Domestic Continued Political Will and Commitment from Senior Management Expanded Effective and Efficient Desktop GMP Inspection for Overseas Manufacturers Timely response to a rapidly changing regulatory environment driven by both PIC/S and advanced regulatory authorities 20

21 Challenges ahead : International On-site GMP Inspection Program for Overseas Manufacturers Team up with other regulatory authorities Shared GMP Inspection report? Joint Inspection Program? Active Engagement with PIC/S Family Business 21

22 Along this journey, we do not seek for perfectionism, but continuous improvement that keeps us abreast with the world. Connecting Pharmaceutical Knowledge ispe.org 22

23 ACKNOWLEDGEMENT Mrs. Prapassorn Thanaphollert Miss Sansanee Manchanda Connecting Pharmaceutical Knowledge ispe.org