the benefits
:: Training opportunities
Pharmaceutical Cooperation/Scheme PIC/S provides a forum for the training of GMP inspectors thus allowing the latter to benefit from increased training opportunities by attending PIC/S Seminars and Expert Circles and by participating in the APSO Joint Visits Programmed. In this respect, APSO is unique as there is no other international training forum run jointly by Regulatory Authorities (individually, Regulatory Authorities or organizations such as WHO or the EMEA provide basic training courses, mainly to new inspectors).
:: International GMP harmonization
By taking part
in the meetings of the APSO Committee, APSO Participating Authorities are
involved in the development and harmonization of international GMP guides and
guidelines. The APSO Committee also actively promotes the uniform interpretation
of GMP and Quality Systems for GMP Inspectorates.
:: Networking
By attending
APSO activities, participants benefit from personal contacts with other
agencies, whether they are part of APSO or not. This networking often simplifies
contacts and the exchange of GMP related information. In addition, APSO is one
of the few international GMP fora for networking and confidence building amongst
regulatory inspectors where experts (GMP inspectors, specialist GMP inspectors
and chief inspectors) can meet, discuss issues of mutual concern and share
experiences and information. In other fora, participation is either at the level
of Heads of Agencies (e.g. WHO) or at the level of experts in a particular
field International Conference on Harmonization (ICH).
:: High standards
APSO ensures
that all Members comply with APSO standards at all times (assessment of new
applicants and reassessment of existing member inspectorates). Preparing for the
accession to the Scheme (or reassessment) forces improvements in the GMP
inspection system and procedures. This results in increased efficiency of the
GMP inspectorate. This is particularly true for Quality System requirements,
where APSO standards are high, and for GMP training, which is essential in APSO.
:: Sharing of information
APSO allows
for a more effective use of inspection resources through the voluntary sharing
of GMP inspections reports. Membership is also a cost-saving measure for the
inspection authorities confronted with an increase of inspections, notably in
the field of Active pharmaceutical ingredients (APIs).
:: Rapid Alert System
Through APSO
membership, Regulatory Authorities automatically benefit from being part of the
APSO Rapid Alert and Recall System arising from quality defects of batches of
medicinal products, which have been distributed on the market. The APSO alert
and recall system is part of a wider system, which includes the alert and recall
system of EU/EEA/MRA partners.
:: Other benefits
Membership in
APSO may also facilitate the conclusion of other agreements, e.g. Mutual
Recognition Agreements, between Members at various levels During the recently
concluded initial negotiation on GMP Inspection, APSO membership accession was
accepted as one of the essential criteria for MRA.
:: Other benefits
There are also
indirect benefits to industry when their relevant regulatory authority becomes a
member of APSO. These benefits may include the following:
Reduced duplication of inspections.
Cost savings.
Export facilitation.
Enhanced market access.
Although APSO is not a trade agreement, membership in APSO may facilitate the export of pharmaceuticals. Some non-PIC/S Authorities in e.g. Colombia and South Africa accept GMP certificates from PIC/S Participating Authorities. Reputable organizations such as the “Global Fund to Fight AIDS, Tuberculosis and Malaria ”consider PIC/S Participating Authorities as “stringent Regulatory Authorities ”meaning that a medicinal product may be pre-qualified by the Global Fund if it has been authorized by a PIC/S Participating Authority. This means that non-PIC/S authorities and organizations have a greater confidence in medicines manufactured in countries where the Regulatory Authority is a PIC/S Participating Authority. Consequently, the pharmaceutical industry located in these countries indirectly benefits from PIC/S membership."