PIC/S membership is open to GMP inspectorates having an inspection system comparable to that of other PIC/S Members (Article 3 of the PIC Scheme). The main conditions are to have a law on medicinal products, a GMP Guide equivalent to that of PIC/S (or the EU GMP Guide), a GMP inspectorate, which fulfils PIC/S quality system requirements, and experienced GMP inspectors.
The exact requirements can be seen from the Audit Checklist (see below "Related Documents") which is applicable to both assessments and reassessments under PIC/S.
Indeed, existing PIC/S Participating Authorities are also reassessed for equivalence on a regular basis. This ensures that both new applicants and older members fulfil the same requirements.
The annual membership fee is currently 8,100 CHF (Swiss Francs). It is paid by full Members. Please note that PIC/S membership implies slightly higher costs, as regular participation in the PIC/S Committee meetings (2 per year), Seminars (1 per year), Expert Circle meetings (3 per year) and Joint Visits (2 to 3 per year) is normally expected from Members. All these events take place in other PIC/S countries around the world and last from 1 to 3 days each. A corresponding travelling budget should thus be ensured.
Applicants have to pay a registration fee, equivalent to the annual membership fee (i.e. CHF 8,100), which will be charged once all the complete application has been submitted to the PIC/S Secretariat. In addition, during the whole assessment process, Applicants will have to pay an annual fee corresponding to 50% of the annual membership fee paid by Members. Fees for the pre-accession process correspond to the covering of the expenses of the PIC/S expert involved in the pre-accession process.
Against payment of the fee, non-PIC/S Agencies, which have applied for accession, can attend PIC/S Committee meetings. They can also attend PIC/S Seminars and Expert Circle meetings. You are encouraged to participate in these activities, as it will allow you to get familiar with the PIC/S family. You have also the possibility to contact other PIC/S Members directly. You can for example visit them in order to exchange information on their GMP system and their way of carrying out inspections.
|quality system requirements for pharmaceutical inspectorates||PI 002-3||2007|
|questionnaire for assessment||PS W 01 2011||2011|
|pic/s scheme||PICS 1/95 (Rev 5)||2011|
|pic/s guidelines for accession||PS W 14 2011 (Rev. 1)||2014|
|pic/s audit checklist||PS W 01 2005 (Rev 2)||2014|