4. Please perform an evaluation of a program at BPOM.

What are the key indicators of such a successful program?

You can analyze by identifying the following factors:
• Program objective
• Resources
• Stakeholders
• Activities
• Outputs
• Short-term outcomes
• Long-term outcomes In the end, you may conclude whether the
program is successful or not
• Program Name : The Pharmaceutical Inspection Co-operation Scheme
(PIC/S) (BPOM has been joined since 2012).
• Objective :
Strengthening the drug and traditional medicine control system to
Ensure Pharmaceutical product (drug and traditional medicine) to be
Safe, have good Quality and efficacy, and also Improving the
competitiveness of National the pharmaceutical industry and
Traditional Medicine Industry
• Resources :
Pre Assesment for membership fee ??
Annually Membership Fee For IDR 125 Million
Contact Point and administration staff
• Stakeholders :
1. PIC/S Authorities
2. Drug/Traditional Medicine Industry
3. The Cabinet Secretary
4. The Ministry of Finance
5. The Ministry of Foreign Affairs
• Activities
1.GM(D)P Harmonisation : The harmonisation of Good Manufacturing Practice (GMP) and more
recently of Good Distribution Practice (GDP) is at the very heart of PIC/S. The development and
promotion of high and harmonised GMP standards and guidance documents has been a key focus
since the start. The reason is obvious: to accept inspection results or have a GMP system equivalent
to other PIC/S Members, you need to rely on common standards.
2.Training : Training Competent Authorities and, in particular, training Inspectors, is an integral and key
activity of PIC/S. The training of GMP Inspectors has been one of PIC/S’ main focal points since the
very beginning. Through this emphasis on training, PIC/S is able to achieve its mission.
3.Compliance : One of the essential requirements to join PIC/S is that Competent Authorities must
have the arrangements necessary to apply an inspection system comparable to that referred to in
this Scheme and whose requirements and procedures could ensure the proper implementation of
the Scheme and contribute to its effective operation. Being equivalent is not only required for
accession but all the time and duly verified during reassessments. This is why compliance to the PIC
Scheme is one of PIC/S’ most important and critical areas, which needs to be constantly monitored.
• Activities (Continue)
3. Expert Circles : Expert Circles have been set up by PIC/S to facilitate the discussions and the exchange of
information among Inspectors specialised in a specific area of GMP such as Blood, Computerised Systems,
Active Pharmaceutical Ingredients, Quality Risk Management, etc. Expert Circles meet regularly to
develop draft guidance, recommendations, etc. and offer training in their respective fields of
specialisation.
4. Strategic Development: The Founders of the PIC Convention had a visionary idea - that of creating a free
trade market for pharmaceutical products and facilitating the international trade while ensuring the best
possible protection of patients through high GMP standards. This was to be achieved by the mutual
recognition of GMP inspections - the PIC Convention - and the harmonisation of GMP standards - the PIC
GMP Guide.
5. Communication : PIC/S regularly communicates on its activities through press releases, annual reports
and - since the start of millennium - its website. Good communication between Participating Authorities
through PA representatives is one of PIC/S’ recognised benefits, which derives from Membership.
Communication has also become an important tool to promote PIC/S. As a result, the PIC/S Committee
has decided to establish a specific Sub-Committee on Communication.
6. Budget, Risk & Audit : No organisation can survive without the support of an efficient, administrative
structure such as a Secretariat. But a high-quality Secretariat must be funded. Risk is inherent to most
organisations: whether regulatory, financial or reputational, all risks must be properly assessed through
regular or special audits and the identified risks must be then either eliminated or minimised.
• Outputs
• Outcomes
Pharmaceutical Industry Export
700

600

500
in Million US $

400

300

200

100

0
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Export Destination

Singapore Japan Philipines Others Total

Source : BPS
• Outcomes