PICs Flashcards
What is PICs
Pharmaceutical Inspection Cooperation Scheme
The aims and objectives of the PIC are
To protect interests of public health by ensuring appropriate standards in manufacture of medicines – whether exported or not
* To ensure that manufacturing control is covered by official inspection
* To set up effective systems of national inspection and testing of pharmaceutical products in member countries
* To contribute to the removal of obstacles in international trade on a wider scale through the recognition of inspections made by national health authorities
The PIC is administered by
the EFTA Secretariat in Geneva, SWITZERLAND, but the articles of the convention and instruments of ratification are deposited in SWEDEN.
Membership of the PICs
The PIC is one of the most far sighted international agreements in existence and it embraces the interests of public health and the removal of obstacles in international trade through the recognition of inspections made by national health authorities. It is quite specific concerning the conditions surrounding membership and operation of the PIC. Some of the salient points of the convention are as follows:
* The main purpose is the exchange of information for mutual recognition of inspections
* The type of information to be provided by one ‘competent authority’ upon request from another (See Appendix 1)
* Restrictions on data to be provided (e.g. sensitive commercial, financial, technical and resource ‘know how’ not related to control of manufacture)
* The proviso that information provided shall be based upon inspection
* What the basis of inspection must cover within the convention
* The powers of the competent authorities (powers to call for records and samples)
* The proviso that inspectors in the competent authorities have ‘appropriate qualifications and experiences for the task to be undertaken by them’
* Mutual recognition that national inspections are equivalent to those carried out in conformance with the provisions of the convention
* Provision for officials of the competent states to meet whenever necessary (but at least once a year) in order to:
a) Make recommendations and proposals for standards of GMP
b) Exchange experience on inspection methods to achieve effectiveness
c) Promote cooperation between states to facilitate application of the convention
d) Promote mutual training of inspectors
e) Propose recommendations for implementing or amending the convention
The purpose of the PIC Scheme is
with due regard to public health:
* To pursue and strengthen the cooperation established between the participating authorities in the field of inspection and related areas with a view to maintaining the mutual confidence and promoting quality assurance of inspections
* To provide the framework for all necessary exchange of information and experience
* To coordinate mutual training for inspectors and for other technical experts in related fields
* To continue common efforts towards the improvement and harmonisation of technical standards and procedures regarding the inspection of the manufacture of medicinal products and the testing of medicinal products by official control laboratories
* To continue common efforts for the development, harmonisation and maintenance of Good Manufacturing Practice (GMP)
* To extend the cooperation to other competent authorities having the national arrangements necessary to apply equivalent standards and procedures with a view to contributing to global harmonisation
Operation of the PIC/S
The PIC guidelines are a particularly valuable source of information on GMP, interpretation of standards, and views of inspection bodies. PIC guidelines (including those on basic standards of GMP) have formed the basis for many of the EU guidelines, and it should be noted that the EMA is a ‘Partner’ organisation with the PICS group. Also the EU guidelines have been adopted by the PIC/S once published.
