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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5335_Библиотеки_им_академика_М_И_Перельмана.pdf
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Philippines. The first three had been PIC/S members since 2000,
2002 and 2012 respectively, and were included in the ASEAN Register of LIS without the need for further technical assessment. On the
other hand, Thailand and Philippines FDA were subject to technical
assessments by an ASEAN PoE before being included in the Register
of ASEAN LIS in 2015 and 2020 respectively. This was because they
were not PIC/S members yet at the point of assessment.
2.10. Benefits of ASEAN Sectoral MRA on GMP
Inspection and Listed Inspection Service (LIS)
The benefits of the ASEAN Sectoral MRA on GMP Inspection, and
of being an ASEAN LIS, include the following items:
• avoidance of duplication of GMP inspections within ASEAN;
• saving of time, resources and costs for the regulator and industry;
• facilitation of trade in medicinal products across ASEAN;
• quicker access of medicinal products by ASEAN patients;
• harmonization of ASEAN inspection framework to that of the
international PIC/S standard; and
• increased attractiveness of ASEAN to investors from larger global
economies such as the US, EU, China, Japan and South Korea.
There is also alignment of the objectives of the ASEAN Sectoral
MRA on GMP Inspection with those of the umbrella AEC. The
overarching objective of AEC is to develop ASEAN into a highly
competitive region, a region of equitable economic development,
with a single market and production base, which is fully integrated
ASEAN Harmonization on Pharmaceutical Inspection
into the global economy. Hence, the ocial ASEAN slogan: One
Vision, One Identity, One Community!
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ASEAN Slogan: One vision, one identity, one community
ASEAN PPWG meeting — Yogyakarta, July 2010
In addition to ASEAN harmonization on GMP inspection for manufacturers of medicinal products, there are also convergence and
harmonization activities going on in other regulatory aspects such
as bioequivalence, ASEAN Common Technical Dossier, and ASEAN
Common Technical Requirements such as stability testing, process
validation and QC testing. ASEAN harmonization is also taking place
for other categories of healthcare products, including traditional and
herbal medicinal products, cosmetic products and medical devices.
Lighter Moments at ASEAN Meetings
As the saying goes, all work and no play makes Jack a dull boy, and
Jane a dull girl. ASEAN events are not just about long, protracted and
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
serious meetings all the time. At all ASEAN events where inspectors
and regulators, industry, partners and stakeholders come together,
there is often an evening of food and drinks, social interactions and
networking, and to “let the hair down” after a week-long meeting.
These evening sessions are for the participants to unwind and to
forge ASEAN camaraderie, friendship and solidarity. During these
evenings, participants from ASEAN Member States often seize the
opportunity to showcase their “hidden talents”. Their performances
can be in the form of a song, a dance or a cultural item. It can be a
solo or a group eort, or it can even be a joint performance by two
or more ASEAN Member States. Attached are some snapshots of the
lighter moments at ASEAN events over the years.
Performance by Indonesia — Yogyakarta, Indonesia, 2010
ASEAN Harmonization on Pharmaceutical Inspection
Performance by Philippines — Yogyakarta, Indonesia, 2010
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Joint performance by Singapore and Philippines — Marina Bay Sands, Singapore,
2011
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
Joint performance by Singapore and Thailand — Bangkok, Thailand, 2017
Performance by Vietnam — Siem Reap, Cambodia, 2018
Chapter 3
Developing a Training and Continuous
Training Program for ASEAN Inspectors
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3.1. Introduction: Urgency of Training ASEAN Inspectors
s mentioned in Chapter 2, the 10 ASEAN Member States
signed a multilateral Sectoral Mutual Recognition
Arrangement (MRA) on GMP Inspection for Manufac-
A
national PIC/S inspection framework was used as the benchmark
for this landmark ASEAN-wide and legally binding treaty. A grace
period of three years from the year of the signing of the MRA (2009)
was given to all ASEAN Member States to comply with all the legal
obligations stipulated under Article 8 of the MRA. During this threeyear grace period, all ASEAN Member States had to work towards
levelling up their inspectorates to operate a PICS-equivalent GMP
turers of Medicinal Products on 10 April 2009. The inter-
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
inspection framework by 2012. This levelling-up process includes the
training and continuous training of ASEAN inspectors.
As also elaborated in Chapter 2, there are five ASEAN Listed
Inspection Services to date. They are the Singapore Health Sciences
Authority (HSA), Malaysia National Pharmaceutical Regulatory
Agency, Indonesia National Agency for Drug and Food Control, the
Thailand Food and Drug Administration (FDA) and the FDA of the
Philippines. With five out of 10 ASEAN Member States in the Register of Listed Inspection Services, ASEAN is ready to expand the
scope of the Sectoral MRA on GMP Inspection. Currently, it covers only the manufacture of pharmaceutical products in finished
dosage forms; it does not include biopharmaceutical products and
active pharmaceutical ingredients (APIs). The ASEAN Joint Sectoral
Committee (JSC) on GMP Inspection is in the midst of expanding
the scope of the Sectoral MRA to include manufacturers of APIs
and biopharmaceuticals. Hence, training ASEAN Inspectors in
GMP compliance and quality assurance of such products is crucial.
Why is the training and continuous training of an inspector so
important? We shall use the game of football as an analogy. Pharmaceutical manufacturers are like football players, comprising
domestic and international (overseas) football players, whilst the
inspectors such as those from the US FDA, Australia Therapeutic
Goods Administration (TGA), UK Medicines and Healthcare products Regulatory Agency (MHRA) and ASEAN play the role of the
referee. On a football pitch, the referee has the unenviable tasks
of confronting any errant player, blowing the whistle when rules
are not obeyed and issuing the yellow and red cards when rules
are flouted. The key role of the referee is to maintain a level and
orderly field for the players, just as the inspectors have to maintain
Developing a Training and Continuous Training Program for ASEAN Inspectors
a level playing field for the pharmaceutical manufacturers based
on international rules, regulations and GMP standards. In this
regard, the ASEAN JSC on GMP Inspection found it prudent to collaborate with other, more experienced regional and international
partners to provide training and continuous training for ASEAN
pharmaceutical inspectors. These partners included the International Society for Pharmaceutical Engineering (ISPE), Korea Ministry of Food and Drug Safety (MFDS) and the Generics and Biosimilars Initiative (GaBI).
3.2. Collaboration with the International Society for
Pharmaceutical Engineering (ISPE)
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A key objective of the ASEAN Economic Community established
in 2015 is the creation of a single market and production base
within ASEAN that is integrated into the global economy. Therefore, ASEAN has to reach out and connect itself with Asia and the
rest of the world for partnerships, beginning with collaboration in
training. ASEAN was fortunate to have ISPE as a committed and
dedicated partner-cum-facilitator soon after the MRA was signed
in 2009.
An ASEAN Training Needs Analysis (TNA) survey was carried out
by ASEAN in collaboration with ISPE in 2010. This survey was
designed, coordinated and facilitated by Ms. Linda Ambrose who
was the former Head of GXP Inspections of the UK MHRA. The key
objectives of this TNA survey were to find out the preferred topics
for GMP training for the inspectors, their preferred training delivery methods, and how GMP training could be made more eective
and appropriate for ASEAN GMP Inspectors. This TNA survey was
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
conducted online over two months from May to June 2010 via a
questionnaire that was sent to all ASEAN GMP Inspectors. The survey was done on an “anonymous” basis where no personal details
were requested from the inspector. About 30% of the total number
of ASEAN GMP Inspectors responded. They included trainees, qualified inspectors as well as inspectors who were managers.
On 7 June 2011, both Ms. Linda Ambrose and Mr. Bob Tribe, representing ISPE, were invited by the Chair of the ASEAN MRA Taskforce (Mr. Sia Chong Hock) to its 9th Meeting which was co-chaired
by Singapore and Malaysia. It was a highly fruitful ISPE-ASEAN
meeting with a framework for training ASEAN inspectors presented very clearly by Linda and Bob. Both were former heads of
inspectorates at UK MHRA and Australia TGA respectively, and
they had vast experience in conducting pharmaceutical inspections
worldwide as well as in training inspectors.
9th ASEAN MRA taskforce meeting, 7 June 2011, Singapore
Developing a Training and Continuous Training Program for ASEAN Inspectors
The training curriculum for ASEAN GMP inspectors was comprehensive and it consisted of three levels:
— Level 1 Induction Training for Recruits; these cover basic GMP
inspection process, market authorization, manufacturer’s authorization and background on PIC/S.
— Level 2 Training for Trainee Inspectors; these focus on the chap-
ters and annexes of the PIC/S GMP Guide, facilitated by coached
inspections.
— Level 3 Training for Qualified Inspectors; these focus on specific
subject matter and areas of specialization for qualified inspectors, also facilitated by coached inspections.
Training delivery methods included coached (mock) inspections,
classroom training sessions, online training courses (via live or
recorded webinars), and the publication of guidance documents as
educational and inspectors’ guidance materials. ASEAN Member
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