Pharmaceutical Inspection Co-operation Scheme

     PIC/S is a combination term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme. PIC/S was established to harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries. PIC/S is also a body that even harmonized relation among regulatory authorities and governments.

Origin and Purpose:

    In 1995, PIC/S was established as a provision to streamline with long back established Pharmaceutical Inspection Convention of 1970 with some flexibility.

   Initially, European Commission is the body permitted to sign agreements with countries outside Europe.

   Since, European Commission is not a member of Pharmaceutical Inspection Convention of 1970, there was some incompatibility among European Law and PIC.

   This incompatibility did not allow EU countries that were members of PIC to have agreement with countries that are seeking to join PIC.

   This led to formation of a PIC Scheme that is a less formal, more flexible, with no legal status that in turn brings understanding between health authorities.

   Thus PIC/S is a parallel scheme of both Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme.

   PIC/S has brought understanding among health authorities and governments and led to joint execution of activities of PIC and PIC scheme.

Role of PIC/S:

   The role of PIC scheme is to safe guard public health by providing good quality medicines by bringing a harmonization in Good Manufacturing Practice among countries.

   To achieve this harmonization, regular awareness along with training, sharing information and experience,implementing procedures to be followed relating to manufacture and quality control of medicinal products so that equivalent standards among countries can be implemented.

   To meet the objective, PIC/S has to thoroughly assess the status of regulatory process of a drug regulatory authority of a country and make necessary changes if necessary in the protocols of manufacturing and quality control of drugs so as to harmonize Good Manufacturing Practice among the member countries.

Advantages with PIC/S:

   PIC/S brings about an international harmonization among countries with relating to Good Manufacturing Practice, quality maintenance systems of medicinal products. In addition to this, implementation of high standards of quality along with mutual understanding among members is achieved.

   PIC/S brings about a single network system relating to GMP of medicinal products and helps member regulatory authorities in sharing, facilitating, recalling, concluding aspects relating to manufacture, quality and inspection systems among inspectorates, pharmaceutical industries.

   Aspects relating to duplication of inspections and other regulatory become cost effective.

   PIC/S also brings about single window export facilitation to enhance marketing of the medicinal products. As a whole, PIC/S brings about uniform licensing decisions among member countries.

   Several countries like Colombia that is a non-PIC/S authority do accept GMP certification from PIC/S member countries for import of the medicinal product which is a benefit.

Objective of PIC and PIC/S:

   The main objective is to harmonize Good Manufacturing Practice requirements, bring about uniform-mutual recognition inspections, educate and exchange information, among different countries and attain mutual confidence of drug regulatory authorities. The key issues like duplication of inspections, licensing procedures, expenditure and licensing can be overcome by one time procedures.

History, Members of PIC and PIC/S:

   Pharmaceutical Inspection Convention was established in 1970 by European Foreign TradeAssociation under the title “The Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products”.

   Initial ten members of EFTA i.e. Austria, Denmark, Finland, Iceland, Liechtenstein, Norway, Portugal, Sweden, Switzerland and United Kingdom were later members of PIC.

   Membership of PIC was subsequently expanded to include Hungary, Ireland, Romania, Germany, Italy, Belgium, France and Australia.

   It was later the PIC scheme established in 1995 that in turn led to PIC/S. Presently, 39 regulatory authorities are members and partners of PIC/S (Annexure A).

Administrative Structure of PIC/S:

   PIC/S is constituted with a permanent committee and executes meetings with representative of participating authorities.

   The meetings are held at least twice a year by the committee. The PIC/S committee is assisted by a secretariat in coordinating, documenting and implementing the objectives of PIC/S. 

Functions of PIC/S Committee:

   To meet the objectives of PIC/S in terms of harmonisation of GMP, the committee makes recommendations, update and improve GMP, promote cooperation relating to quality assurance of inspections and quality systems of inspectorate, educate the authorities by means of training and exchange of information and helps in bringing out new guidelines relating to manufacturing and quality control of medicinal products.

   The committee also assesses the system being practiced by a country for medicinal products in terms of manufacture, quality control along with protocols followed for corresponding regulatory inspections/inspectors and decides suggestions and changes necessary for the country to become a member of PIC/S.

 
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