PIC and the PIC Scheme, operating together in parallel, are jointly referred to as PIC/S. The PIC Scheme, and thus PIC/S was founded on 2 November 1995 with the intention of continuing and enhancing the goals of PIC, which had been founded in 1970.
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), and
- 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.
A permanent Committee composed of representatives of the participating authorities meet at least twice a year to:
- consider measures for achieving the appropriate and effective operation of the Scheme,
- make recommendations and proposals for the amendment, updating and improvement of standards of good manufacturing practice currently applied under the Scheme,
- promote cooperation between the competent authorities to facilitate the application of the Scheme,
- exchange information and experience on means and methods for achieving uniform and effective inspections,
- promote quality assurance of inspections and quality systems for inspectorates,
- promote mutual training for inspectors by means of Seminars dealing with the state of the art of GMP knowledge in all necessary fields, and of joint visits for the harmonisation of inspections,
- promote the exchange of experience on special categories of medicinal products in relation to GMP aspects (eg. blood products, radio-pharmaceuticals, biotechnologically manufactured medicinal products),
- promote the exchange of experience between, and mutual training of, personnel of official control laboratories,
- discuss and decide on the participation of competent authorities of other countries,
- make proposals for amendments to the Scheme,
- contribute to the development of new Guides and Guidance documents applicable to different types of production and quality control, or different manufacture, and
- promote global harmonisation of GMP.
A Secretariat provides assistance in the functioning of the Committee, maintaining PIC/S documentation and the coordination and operation of other PIC/S activities.
A PIC/S training Seminar, attended by GMP inspectors from participating
authorities and other authorities interested in joining PIC/S, is held
each year. Each Seminar focuses on a particular aspect of GMP, with the
aim of providing training and harmonisation in the subject. The
proceedings of these Seminars are subsequently published in booklet form,
and are available for purchase from the PIC/S Secretariat. A list of
Seminar topics is shown in
Publications
The annual PIC/S Seminar usually results in the formation of a working group to develop a draft Guidance or Recommendations. For example, the 1994 Seminar on validation resulted in the preparation and issue of PIC/S Recommendations on Validation (available for purchase from the PIC/S Secretariat).
Another avenue for the training of inspectors from PIC/S participating authorities is the joint visits program for the training of inspectors. Under this program, three inspectors from three different countries are teamed up to observe typical inspections in each country with a view to comparing inspection procedures and techniques. Any differences in inspection procedures and techniques are reported to the PIC/S Working Group on Training for appropriate action. Joint visit groups are also encouraged to recommend specific training needs for inspectors, including topics for future PIC/S Seminars.
PIC/S has formed several "Expert Circles" to enable inspectors to discuss and exchange information on specific technical areas of GMP. Expert Circles on Medicinal Gases, Blood Banks and Hospital Pharmacy are currently active and meet at least annually. The aim of the Expert Circles is to develop draft Guidance, Recommendations or Aide Memoir, or new Annexes to the GMP Guide.
Before a regulatory authority can become a member of the PIC Scheme, a detailed assessment is undertaken to determine whether the authority has the arrangements and competence necessary to apply an inspection system comparable to that of current PIC/S members. This assessment involves an examination of the authority’s inspection and licensing system, quality system, legislative requirements, inspector training, etc, and is followed by a visit by a PIC/S delegation to observe inspectors carrying out actual GMP inspections.
