PIC/S [Pharmaceutical Inspection Convention and Pharmaceutical Inspection Scheme]
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme are two international instruments between countries and pharmaceutical inspection authorities.
Founded:- 26 May 1971.
Purpose:- Pharmaceutical drug.
Headquarters:- Geneva, Switzerland.
Membership:- 52 Active state members.
Type of Organization:- Intergovernmental organization.
Pharmaceutical Inspection Co-operation Scheme was established in 1995 as it is an extension of the Pharmaceutical Inspection Convention which was founded in 1970.
Founded by:- The European Free Trade Association (EFTA) under the title of “The Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products”.
Aim of PIC foundation:- Removal of non-tariff barrier in trade of pharmaceutical in Europe through mutual recognition of inspection report and certification on good manufacturing Practice.
Basic Motive/ Idea behind the Establishment of PIC/S:- It 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.
History behind the Establishment of PIC/Scheme:- In 1989, the EU adopted its own GMP Guide- which, in terms of GMP Guide, which in terms of GMP- in terms of GMP requirements- is equivalent to the PIC/S Guide. Since that time, the EU and the PIC/S GMP Guides have been developed in parallel (both Guides are practically identical). 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. It was later the PIC scheme established in 1995 that in turn led to PIC/S.
Members/ Participating Members: – There was the legal treaty between the 10 member countries initially, i.e., Austria, Denmark, Finland, Iceland, Liechtenstein, Norway, Portugal, Sweden, Switzerland and United Kingdom. Later on other countries Hungary, Ireland, Romania, Germany, Italy, Belgium, France and Australia became members of the PIC as it was expanded subsequently.
- Not- Participating: India, China, Brazil and Russia.
Participating Countries ( Coloured Blue) :
HOW TO JOIN PIC/S:-
- Before an Authority is accepted by PIC/S, a detailed assessment is carried out to determine whether the Authority is able to apply an inspection system comparable to that of current PIC/S Authorities. This assessment involves an examination of the Authority’s GMP inspection and licensing system, quality system, legislative requirements, inspector training etc. It is followed by a PIC/S delegation to observe in particular inspectors carrying out routine GMP inspections.
- Membership may take several years to achieve, during which time various changes and improvements may be recommended by the PIC/S Committee; if necessary, follow- up visits are undertaken to verify the suitability of corrective actions.
- PIC/S recently introduced a gap analysis to identify areas of non- compliance with PIC/S requirements.
- In line with the Joint Reassessment Programme, existing PIC/S Participating Authorities are also released for equivalence on a regular basis. This ensures that both new applicants and older members fulfill the same requirements.
Meetings Held:- The meetings are held at least twice a year by the committee.
Benefits of PIC/S Registration or Membership:-
- Training opportunities:PIC/S provides a forum for the training of GMP inspectors by attending PIC/S Seminars, 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).
- Networking:By attending PIC/S activities, participants benefit from personal contacts with other agencies, whether they are part of PIC/S or not. 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). This is particularly true for Quality System requirements, where PIC/S standards are high, and for GMP training, which is essential in PIC/S.
- 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/MRA 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.
- Reduced duplication of inspections.
- Cost savings.
- Export facilitation.
- Enhanced market access.
Why PIC/S compliance is important?
A company manufacturing and supplying pharmaceuticals to multiple countries would be subjected to audits from the regulatory bodies of each country. For those countries who are members of PIC/S, an audit by another PIC/S member country will be accepted without the need for a further audit.
Let’s quote an example:–
Company X ships product to Australia, Singapore and Malaysia. They have been audited by the Australian regulatory body [Therapeutic Goods Administration (TGA)] and have been granted a GMP licence. As Australia, Singapore and Malaysia– all are members of PIC/S, Singapore and Malaysia will accept Company X’s products without their regulatory bodies performing an audit on Company X. Once one PIC/S member country has confirmed that a manufacturer meets GMP requirements then all other PIC/S member countries will usually accept the GMP certification without performing and inspection and assessment themselves.
Difference between PIC/S:
|Established 1970||Established 1995|
|Between 18 countries||Between 49 Agencies (NDRA) in the field of GMP for human or vet. use|
|An informal arrangement||A formal treaty|
|Has no legal status||Has legal status|
|Between Health authorities||Between countries|
|Exchange of information||Mutual recognition of inspections|
Related article links-
PIC/S [Pharmaceutical Inspection Convention and Pharmaceutical Inspection Scheme]- Guidelines & Links
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