THAILAND PIC/S ACCESSION:

JOURNEY TOWARDS THE 49TH 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

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Historical Evolution of GMP Inspections

in Thailand
1986

Encourage Modern Medicine manufacturers (MM)

to implement WHO GMP on voluntary basis

2003

1st 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

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 4th ASEAN Listed Inspection

Service

Historical Evolution of GMP Inspection

in Thailand (Cont.)
Mar 2015

Official submission of application through

PIC/S accession procedure

Mar 2016

PIC/S On-site assessment

May 2016

New Public Health Ministerial Notification to Implement

PIC/S GMP Guides PE009-12

5 Jul 2016

PIC/S Committee invited Thai FDA to join the scheme

as PIC/S49th Participating Authority (PA)

1 Aug 2016

Officially became 49th PIC/Ss PA

1st Round Application

February 2006 - 2012
24 Feb 2006
May 2007
21-25 Jan 2008

31 Jul 2008
28 Jan 2009
1 Oct 2009
28 Feb 2012
Feb 2012

Submission of application
Paper Assessment
On-site Assessment based on 89 indicators
Findings: 29 deficiencies
Critical deficiencies =5
Major deficiencies =18
Minor deficiencies = 6
Submission of CAPA
Submission of CAPA
Submission of progress report
Submission of progress report
Termination of application

PIC/S Assessment Team: 1st Application

PIC/S Assessment Team

Affiliation

Mr. Jacques Mornas, Rapporteur

AFSSAPS/France

Ms. Kadariah Mohd Ali, Co-rapporteur

NPCB / Malaysia

Mr. Boon Meow Hoe , Co-rapporteur

HSA / Singapore

Mr. Paul Sexton, Co-rapporteur

IMB / Ireland

Mr. Andr Kovacs, Co-rapporteur

PIC/S Secretariat

2nd Round Application

20 March 2015

PIC/S Paper Assessment

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PIC/S Assessment Team: 2nd Round

PIC/S Assessment Team

Affiliation

Mr. Jacques Mornas, Rapporteur

AFSSAPS/France

Mr. Boon Meow Hoe , Co-rapporteur

HSA/ Singapore

Ms. Gaye Camm, Co-rapporteur

TGA/ Australia

Ms. Shanti Marlina, Co-rapporteur

NADFC/ Indonesia

PIC/S On-site Assessment

Opening
Meeting
14 March 2016
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PIC/S On-site Assessment

Closing Meeting: 18 March 2016

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Cheerful Group Picture

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Outcome of On-site assessment

PIC/S requirements (78 indicators)
Fully fulfilled

Fully fulfilled
with condition

Partially fulfilled

73 indicators

3 indicators

2 indicators

Outcome of On-site assessment

Indicator
#
11
29
69

73
76

PIC/S requirements
Fully fulfilled
Partially fulfilled
with condition
X

X
when implemented
X
subject to receiving new SOP
Recall and rapid alert system
X
subject to receiving new QM
X

Journey towards PIC/S Membership

Journey towards PIC/S Membership (cont.)

PIC/S Accession Letter of Thai FDA

Journey towards PIC/S Membership

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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.
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Knowledge

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22

ACKNOWLEDGEMENT

Mrs. Prapassorn Thanaphollert

Miss Sansanee Manchanda

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