Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

International pharmaceutical inspection agreement

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international cooperative arrangement between regulatory authorities in the field of Good Manufacturing Practice (GMP) for medicinal products for human or veterinary use. The primary goal of PIC/S is to harmonize inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors.

History

The Pharmaceutical Inspection Convention was established in October 1970 by the European Free Trade Association (EFTA) under the title "Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products." The aim was to create a framework for mutual recognition of inspections and to facilitate the exchange of information between regulatory authorities.

In 1995, the Pharmaceutical Inspection Co-operation Scheme was established to extend the reach of the Convention beyond Europe, allowing non-EFTA countries to join. This was a significant step in promoting global harmonization of GMP standards.

Objectives

The main objectives of PIC/S are:

• To facilitate cooperation and networking between competent authorities and international organizations.
• To maintain mutual confidence, exchange information and experience in the field of GMP.
• To coordinate mutual training for inspectors.
• To improve the use of resources in the field of GMP inspection.

Structure

PIC/S is composed of two main bodies:

• The Committee, which is the decision-making body responsible for the overall management of PIC/S.
• The Secretariat, which provides administrative support and is responsible for the day-to-day operations.

Membership

Map of PIC/S members

Membership in PIC/S is open to any authority having a comparable GMP inspection system. As of 2023, PIC/S has 54 participating authorities from all over the world, including countries from Europe, Asia, Africa, and the Americas.

Activities

PIC/S conducts a variety of activities to achieve its objectives, including:

• Organizing seminars and training sessions for inspectors.
• Developing and maintaining GMP guidelines and standards.
• Facilitating the exchange of information and experiences among member authorities.
• Conducting joint inspections and assessments.

Impact

The impact of PIC/S is significant in the field of pharmaceutical manufacturing. By harmonizing GMP standards and inspection procedures, PIC/S helps ensure the quality and safety of medicinal products globally. It also reduces duplication of inspections, saving resources for both regulatory authorities and the pharmaceutical industry.

Related pages

• Good Manufacturing Practice
• European Medicines Agency
• World Health Organization

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme