PIC/S Guidelines for GMP in Pharmaceuticals

What is PIC/S:

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use.

It is open to any Authority having a comparable GMP inspection system. PIC/S presently comprises 54 Participating Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia).

PIC/S aims at harmonizing inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to Inspectors.

It also aims at facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing mutual confidence. This is reflected in PIC/S’ mission which is to lead the international development, implementation and maintenance of harmonized GMP standards and quality systems of inspectorates in the field of medicinal products.

History of PIC/S:

PIC/S was founded in 1995 as an extension to PIC (Pharmaceutical Inspection Convention) which was founded in October 1970 by EFTA (European Free Trade Association) under the title of “The Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products”. 

The initial Members of PIC comprised the 10 Member countries of EFTA at that time, ie. Austria, Denmark, Finland, Iceland, Liechtenstein, Norway, Portugal, Sweden, Switzerland and United Kingdom. Membership of PIC was subsequently expanded to include Hungary, Ireland, Romania, Germany, Italy, Belgium, France and Australia.

It was realised in the early 1990s that because of an incompatibility between the Convention and European law, it was not possible for new countries to be admitted as Members of PIC. Australia was the last country that was able to become a Member of PIC in January 1993. Consequently, the PIC Scheme was formed on 2 November 1995. PIC and the PIC Scheme, which operate together in parallel, are jointly referred to as PIC/S.

The original goals of PIC were:

  • Mutual recognition of inspections;
  • Harmonization of GMP requirements;
  • Uniform inspection systems;
  • Training of Inspectors;
  • Exchange of information;
  • Mutual confidence.

Benefits :

PIC/S offers a variety of advantages to its Participating Authorities. Some of the main benefits for Medicines Regulatory Authorities resulting from PIC/S Membership are detailed below. PIC/S Membership also involves indirect benefits to industry, when their relevant Medicines Regulatory Authority becomes a Member of PIC/S.

Main benefits for Members

  • Training opportunities: 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 PIC/S Joint Visits Programme. In this respect, PIC/S is unique as there is no other international training forum run jointly by Regulatory Authorities (individually, Regulatory Authorities or organisations such as WHO or the EMA provide basic training courses, mainly to new Inspectors).
  • International GMP harmonization: By taking part in the meetings of the PIC/S Committee, PIC/S Participating Authorities are involved in the development and harmonisation of international GMP guides and guidelines. The PIC/S Committee also actively promotes the uniform interpretation of GMP and Quality Systems for GMP Inspectorates.
  • Networking: By attending PIC/S activities, participants benefit from personal contacts with other agencies, whether they are part of PIC/S or not. This networking often simplifies contacts and the exchange of GMP related information. In addition, PIC/S 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 (ICH).
  • High standards: PIC/S ensures that all Members comply with PIC/S 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 PIC/S standards are high, and for GMP training, which is essential in PIC/S.
  • Sharing of information: PIC/S 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 PIC/S Membership, Regulatory Authorities automatically benefit from being part of the PIC/S Rapid Alert and Recall System arising from quality defects of batches of medicinal products, which have been distributed on the market. The PIC/S Alert and Recall System is part of a wider system, which includes the Alert and Recall System of EU/EEA (European Economic area) /MRA (Mutual recognition agreements) partners.
  • Facilitating the conclusion of other Agreements: Membership in PIC/S may also facilitate the conclusion of other agreements, e.g. Mutual Recognition Agreements, between Members at various levels (e.g. Australia-Canada MRA, EU-Switzerland MRA, etc.). During the recently concluded initial negotiation on ASEAN MRA on GMP Inspection, PIC/S Membership accession was accepted as one of the essential criteria for MRA (Mutual recognition agreements).

Indirect Benefits for Industry:

There are also indirect benefits to industry when their relevant Regulatory Authority becomes a Member of PIC/S. These benefits may include the following:

Reduced duplication of inspections;

Cost savings;

Export facilitation;

Enhanced market access.

Organisational Structure :

As the PIC Scheme is an arrangement between Regulatory Authorities, it is very flexible, dynamic and proactive. A Committee of the Participating Authorities’ representatives (PIC/S Committee) supervises the operation of the Scheme. All decisions are taken unanimously. The Committee is assisted in its task by 7 Sub-Committees (e.g. on the training of Inspectors, on GMO/GDP harmonisation, etc.), by an Executive Bureau, which steers the Organisation in between meetings, and by a small Secretariat, which mainly assists the Committee, the Sub-Committees, the Bureau and Participating Authorities in their duties.

Reference : https://picscheme.org/en/picscheme

PIC\S Guideline documents : https://picscheme.org/en/publications?tri=all#zone


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