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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
including the establishment of an ASEAN Register of LIS. Singapore and Malaysia continued to be the Chair and Co-Chair respectively of this JSC. By the year 2012, there were three PIC/S members among the 10 ASEAN Member States. Singapore HSA had
been a PIC/S member since 1 January 2000, followed by Malaysia
National Pharmaceutical Control Bureau (NPCB) since 1 January
2002 and Indonesia National Agency for Drug and Food Control
(NADFC) since 1 July 2012. Being PIC/S Members, they were the
first three ASEAN Member States recommended to be included in
the ASEAN Register of LIS without the need for any further technical assessment of their inspection services.
Flow chart on application to be ASEAN LIS
ASEAN Harmonization on Pharmaceutical Inspection
2 .7. Assessment of Thai Food and Drug Administration
(FDA) by ASEAN Panel of Experts (PoE)
In June 2013, the Thai Food and Drug Administration (FDA) submitted an ocial application, through the ASEAN Secretariat, to be
a LIS. As the Thai FDA was not yet a PIC/S member then, an ASEAN
Panel of Experts (PoE) was appointed to assess the application from
the Thai FDA. The members of the ASEAN PoE comprised Mr. Sia
Chong Hock from Singapore HSA as the Rapporteur, together with
Mr. Sulaiman Ahmad from Malaysia NPCB and Mr. Bayu Wibisono from Indonesia NADFC as Co-Rapporteurs. From June 2013
to August 2014, the ASEAN PoE assessed the supporting documents
submitted by the Thai FDA in connection with its application to be
the 4th ASEAN LIS. By September 2014, the Thai FDA was deemed
to be ready for on-site evaluation at its inspectorate oce in Bangkok. However, just barely two months before the ASEAN PoE was
due to travel to Thailand, martial law was imposed in the country.
This triggered serious concerns as to whether the on-site assessment
should proceed or not. Members of the ASEAN PoE were very concerned about their personal safety and requested that the trip be
postponed. However, our Thai FDA colleagues assured us that every
eort would be taken to accord the necessary “security arrangements and protection” for all three members of the ASEAN PoE. As
a result, the members of the PoE remembered being received personally at Suvarnabhumi International Airport in Bangkok by their
Thai GMP inspector counterparts, and being whisked straight away
from the airport to their hotel. During the one-week stay in Bangkok, our Thai counterparts also stayed at the same hotel so as to be
around the ASEAN PoE members, in case they needed any urgent
assistance. This was a classic example of ASEAN solidarity and
approach of doing things together like a closely knitted family. All
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
these arrangements helped to allay the safety and logistic concerns
of the ASEAN PoE members. With this, the ASEAN PoE was able
to focus on its key tasks at hand, that is, to verify the technical competency of the Thai FDA to be included in the Register of ASEAN
LIS. The ASEAN PoE members were able to meet and discuss daily
with one another as well as with their Thai FDA counterparts at the
same hotel. The PoE assessment of the Thai FDA was a milestone
event which was like a “full-dress orchestral rehearsal” to prepare
for more ASEAN PoE assessments to come in the near future.
The week-long ASEAN PoE assessment of the Thai FDA included an
evaluation of the legal framework of Thailand with respect to the
inspection and licensing of pharmaceutical manufacturers, as well
as the enforcement actions which may be taken by the Thai FDA
in the event that there are non-compliant manufacturers or defective medicinal products being produced. The ASEAN PoE team also
scrutinized the Quality System of the Thai FDA inspectorate. The
assessment by the ASEAN PoE also included observations of two
teams of Thai FDA inspectors carrying out their GMP inspections
ASEAN Harmonization on Pharmaceutical Inspection
of Thai Otsuka and Biolab, which were manufacturers of sterile and
non-sterile medicinal products respectively. It must be emphasized
here that the ASEAN PoE members were not inspecting Thai Otsuka
and Biolab. Rather, the ASEAN PoE members were observing how
the Thai FDA Inspectors carry out a GMP inspection of these two
manufacturing facilities. The ASEAN PoE members were ascertaining whether the PIC/S GMP standard was being followed by
the pharmaceutical inspectors from the Thai FDA, and whether the
inspectors were asking appropriate questions when interviewing the
manufacturing personnel. In short, the ASEAN PoE members were
“inspecting the inspectors”, and not inspecting the manufacturers.
The ASEAN PoE team was provided with two interpreters to help in
their observations, assessment and overall verification of technical
competency. For a more holistic assessment, the ASEAN PoE team
also visited the Department of Medical Sciences which is the Ocial
Medicines Control Laboratory (OMCL) of Thailand. At this OMCL,
the ASEAN PoE was able to evaluate the Quality Control (QC) and
analytical capability of the Thai FDA. The ASEAN PoE team was able
to verify that the Department of Medical Sciences had been certified
to the ISO 17025 standard, prequalified as a QC laboratory under the
WHO Pre-qualification program, and had been designated as a WHO
Collaborating Centre for Quality Assurance of Essential Medicines.
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Overall, the Thai FDA, including the Department of Medical
Sciences, was assessed and found to have met all the technical competency requirements under the ASEAN Sectoral MRA on GMP
Inspection, which were benchmarked to those under the PIC/S
framework. On the final day of the assessment (12 September 2014),
the ASEAN PoE team was pleased to announce to the Thai FDA that
its inspectorate would be recommended for inclusion as an ASEAN
LIS. To mark this historic occasion, a group photograph (below) was
taken of ASEAN PoE together with sta from the Thai FDA sta
on the final day of the on-site assessment. The GMP inspectors, who
were the heroes, occupied the front row. The entire senior management of the Thai FDA (middle row) came out in full force to support and to join in the celebration. In 2015, the Thai FDA ocially
became the 4th ASEAN LIS. The Thai FDA did not rest on its laurels. Soon after being the 4th ASEAN LIS, the Thai FDA submitted
an ocial application to accede to PIC/S. Being an ASEAN LIS had
certainly helped to facilitate its PIC/S accession journey.
Thai FDA became the 4th ASEAN Listed Inspection Service
Group photo taken at Thai FDA oce, Nonthaburi, Thailand – 12 September 2014
ASEAN Harmonization on Pharmaceutical Inspection
With eect from 1 August 2016, the Thai FDA became the 49th
PIC/S Member. Shown below is a photograph which was taken at
the PIC/S Meeting and Annual Seminar held in Manchester, UK in
July 2016. The Thai FDA Secretary General, Dr Boonchai Somboonsook, and his senior ocials, namely, Dr Suchart Chongprasert
and Mrs. Prapassorn Thanaphollert, together with PIC/S ocials,
namely, Mr. Jacques Morenas, the PIC/S Rapporteur from France
and Mr. Daniel Brunner, the PIC/S Secretary, are in the photograph.
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2.8. Assessment of FDA Philippines by ASEAN PoE
FDA Philippines submitted an ocial application to be an ASEAN
LIS on 8 March 2015. Between 2015 and 2018, there was extensive
desktop assessment of the supporting documents submitted by FDA
Philippines as well as intensive discussions with senior FDA Philippines sta at regular ASEAN and ad-hoc ocial meetings. By the
end of 2018, the ocially appointed ASEAN PoE team was satisfied
that the pharmaceutical inspection service of FDA Philippines was
ready for an on-site assessment in Manila. The on-site assessment
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
of FDA Philippines was conducted from 1 to 5 April 2019 (photographs below). Members of the ASEAN PoE which assessed FDA
Philippines comprised:
(a) Mr. Sia Chong Hock — Singapore HSA, Rapporteur
(b) Ms Belinna Abu Bakar — Malaysia NPRA, Co-Rapporteur
(c) Ms Nani Handayani — Indonesia NADFC, Co-Rapporteur
(d) Mr. Pinpong Intarapanich — FDA Thailand, Co-Rapporteur
The ASEAN PoE members conducted interviews and discussions
with the senior management of FDA Philippines, the GMP inspectors as well as the rank-and-file sta. The ASEAN PoE also observed
two teams of FDA Philippines inspectors conduct audits of Hizon
Laboratory Inc., a manufacturer of sterile products and Amherst
Laboratory, a manufacturer of non-sterile medicinal products.
An Audit Checklist, comprising 11 components and a total of 78
indicators, was used by the ASEAN PoE for the assessment of FDA
Philippines. This set of 78 indicators was adopted in its entirety
from the PIC/S Audit Checklist. Most, if not all, ASEAN inspectorates are familiar with the Audit Checklist and 78 indicators as this
document is readily and openly available to them via the internet.
ASEAN Harmonization on Pharmaceutical Inspection
The assessment of FDA Philippines covered the legislative and regulatory requirements, directives, policies, GMP standards, inspection
resources, procedures and performance standards, analytical capability and its overall quality management system.
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On-site assessment of FDA Philippines – 1 to 5 April 2019
From the assessment by the ASEAN PoE team, the FDA Philippines
was found to have fulfilled most of the 78 Indicators. For the indicators which were found to be unfulfilled or partially fulfilled, a corrective action and prevention action (CAPA) report was requested
from FDA Philippines. The CAPA report submitted by FDA Philippines was subsequently evaluated and found to be in order. At this
historic occasion, the Director-General of FDA Philippines, Ms Nela
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Summary of Audit Checklist
Component Sub-component
1. Legislative and Regulatory
Requirement and Scope
2. Regulatory Directives and
Policies
3. GMP Standards 3A - Details/Scope of GMP
4. Inspection Resources 4A - Staffing: Initial Qualification
5. Inspection Procedures 5A - Inspection Strategy
6. Inspection Performance
Standards
7. Enforcement Powers and
Procedures
8. Alert and Crisis Systems 8A -Alert Mechanisms
9. Analytical Capability 9A - Access to Laboratories
10. Surveillance Programme 10A - Sampling and Audit Procedure
11. Quality Management System 11A - Quality Management System
1A - Empowering Legislation
1B - Conflict of Interest
2A - Procedures for Designating Inspectors
2B - Enforcement Policies
2C - Code of Conduct/Code of Ethics
2D - Training Certification Policies/Guidelines
2E - Alert/Crisis Management
Policies/Procedures/Guidelines
2F - Organizational Structure
3B - Process Validation
4B - Number of Inspectors
4C - Training Programme
4D - QA Mechanism to Assure Effectiveness of Training
Programme
5B - Pre-inspection Preparation
5C - Format and Content of Inspection Reports
5D - Inspection Methodology
5E - SOP for Conducting Inspection
5F - Inspection Procedures: Post-inspection Activities
5G - Inspection Procedures: Storage of Inspection Data
6A - Performance Standards
7A - Provision for Written Notice of Violations
7B - Non-compliance Management
7C - Appeal Mechanism
7D - Other Measures
8B - Crisis Management Mechanisms
8C - Alert Performance Standards
9B - SOPs for Analytical Support
9C - Validation of Analytical Methods
10B - Recall Monitoring
10C - Consumer Complaint System
10D - Adverse Reaction Reporting System/Procedures
10E - Medicinal Product Reporting System/Procedures
Audit checklist for ASEAN PoE: 11 components
ASEAN Harmonization on Pharmaceutical Inspection
ASEAN audit checklist: 78 indicators
Source: Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Charade Puno, extended her heartfelt thanks to the ASEAN PoE as
well as to her FDA Philippines team who had worked very hard to
achieve this recognition. During her tenure as the Director-General
of FDA Philippines, she had laid out a long-term quality strategy for
FDA Philippines. With eect from January 2020, FDA Philippines
became the 5th ASEAN LIS. It can be expected that FDA Philippines
will now strive to become a Participating Authority of PIC/S, in the
same way as what the Thai FDA had done and achieved, soon after
becoming the 4th ASEAN LIS.
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2.9. Register of ASEAN Listed Inspection Services (LIS)
To date, there are five ASEAN LIS. They are the Singapore HSA,
Malaysia NPRA, Indonesia NADFC, Thailand FDA and FDA