THAILAND PIC/S ACCESSION: JOURNEY TOWARDS THE 49 TH PIC/S PARTICIPATING AUTHORITY 20 Mar 2015 1 Aug 2016 Suchart Chongprasert, Ph.D. Food and Drug Administration Thailand
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
Historical Evolution of GMP Inspections in Thailand 1986 Encourage Modern Medicine manufacturers (MM) to implement WHO GMP on voluntary basis 2003 1 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 PE009-09 3
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 2014 1st Implementation of GMP inspections for Traditional Medicine manufacturers (TM) under Public Health Ministerial Notification following PIC/S guideline PE009-09 Mar 2015 Acceding to become 4 th ASEAN Listed Inspection Service 4
Historical Evolution of GMP Inspection in Thailand (Cont.) Mar 2015 Mar 2016 May 2016 5 Jul 2016 1 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 PE009-12 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
24 Feb 2006 May 2007 1 st Round Application February 2006-2012 Submission of application Paper Assessment 21-25 Jan 2008 On-site Assessment based on 89 indicators Findings: 29 deficiencies Critical deficiencies =5 Major deficiencies =18 Minor deficiencies = 6 31 Jul 2008 28 Jan 2009 1 Oct 2009 28 Feb 2012 Feb 2012 Submission of CAPA Submission of CAPA Submission of progress report Submission of progress report Termination of application
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
2 nd Round Application 20 March 2015 PIC/S Paper Assessment Connecting Pharmaceutical Knowledge ispe.org
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
PIC/S On-site Assessment Opening Meeting 14 March 2016 Connecting Pharmaceutical Knowledge ispe.org
PIC/S On-site Assessment Closing Meeting: 18 March 2016 Connecting Pharmaceutical Knowledge ispe.org
Cheerful Group Picture Connecting Pharmaceutical Knowledge ispe.org
Outcome of On-site assessment PIC/S requirements (78 indicators) Fully fulfilled Fully fulfilled with condition Partially fulfilled 73 indicators 3 indicators 2 indicators
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
Journey towards PIC/S Membership
Journey towards PIC/S Membership (cont.)
PIC/S Accession Letter of Thai FDA
Journey towards PIC/S Membership Connecting Pharmaceutical Knowledge ispe.org
On becoming PIC/S PA: Key Lessons Learned Political Will & Commitment from Senior Management Quality System in Place Determination of Team Thai FDA
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
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
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
ACKNOWLEDGEMENT Mrs. Prapassorn Thanaphollert Miss Sansanee Manchanda Connecting Pharmaceutical Knowledge ispe.org