Frequently Asked Questions

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Does PIC/S issue GMP Certificates?

PIC/S does not issue GMP Certificates. GMP certificates are issued by PIC/S Participating Authorities (for the full list of our Members, see here).
If you wish to export to a country whose Regulatory Authority is a PIC/S Member, you first need to register your medicinal product with that Regulatory Authority. It’s only once your product has been registered that a GMP inspection will be organised by the relevant Regulatory Authority.

Can PIC/S provide information on the compliance of manufacturers with PIC/S requirements?

PIC/S does not have a list of companies which comply with the PIC/S GMP Guide. This information is considered to be confidential. If you are looking for a specific product, you must contact all companies which produce it and ask them if they have been issued a GMP Certificate from a PIC/S Participating Authority, as listed on our website. It is up to each company to decide whether to share this information with you or not.

Are PIC/S training activities open to industry?

PIC/S membership and PIC/S training events such as Seminars and Expert Circle meetings are restricted to GMP inspectors from Regulatory Authorities. Due to potential conflicts of interests, companies cannot participate in our training events. Some specific training events such as the PIC/S-PDA Q7 Training Courses, part of the PIC/S International Training Programme for APIs, are open to both regulators and industry.

Do PIC/S Members recognise GMP Certificates from other PIC/S Members?

For PIC/S Members, which are part of the European Union (EU) / European Economic Area (EEA), they will mutually recognise GMP Certificates. Example: France and Poland.For PIC/S Members, which have a Mutual Recognition Agreement (MRA) with the European Union (EU) / European Economic Area (EEA), they will mutually recognise GMP Certificates issued for the domestic market. Example: Canada and EU Member States. For PIC/S Members, which are parties to the Pharmaceutical Inspection Convention and which still apply it, they will mutually recognise GMP Certificates issued for the domestic market. Example: Australia and Switzerland. For all other PIC/S Members, there is no obligation to recognise GMP Certificates from other PIC/S Members. In all cases, it is best to check directly with the relevant Regulatory Authorities whether they accept a GMP Certificate.

Do non-PIC/S Members recognise GMP Certificates from PIC/S Members?

If a Regulatory Authority is not a PIC/S Participating Authority, they may unilaterally recognise GMP Certificates from PIC/S Participating Authorities. If you have already a GMP Certificate from a PIC/S Participating Authority, please check directly with the relevant non-PIC/S Participating Authority whether they accept it.

Does PIC/S perform inspections and certify individual company plants?

PIC/S as such does not inspect pharmaceutical companies and does not certify companies.

Can PIC/S provide advice or consultancy services to industry or consultants?

Unfortunately, due to our conflict of interests' policy, PIC/S is not in a position to provide any consultancy services to industry. You may wish to submit your request directly to the relevant PIC/S Participating Authority or to a consultant, who has experience in the relevant field.

To whom is PIC/S Membership open?

Membership to PIC/S is restricted to Regulatory Authorities. Individuals cannot join our organisation. The same is valid for companies.

Can PIC/S provide clarifications or advice on a PIC/S document?

PIC/S is not in a position to help you with specific questions related to the PIC/S GMP Guide or other PIC/S guidance documents. All companies are requested to first contact the local GMP Inspectorate in their country or a GMP consultant.

Does PIC/S have a French version of the PIC/S GMP Guide?

Unfortunately, we do not have a French translation of our PIC/S GMP Guide. For your information, the PIC/S GMP Guide is equivalent (but not identical) to the EU GMP Guide. The French Ministry of Health publishes the EU GMP Guide on its web site in French http://www.sante.gouv.fr/plan-de-classement-bulletins-officiels-speciaux.html under "B4 Pharmacie".

Are the PIC/S and the EU GMP Guides harmonised?

Yes, the PIC/S and EU GMP Guides are kept harmonised. Since 2013, PIC/S is also involved in EMA drafting groups regarding the revision of the EU GMP Guide and public consultations are done in parallel (PIC/S and EU).

Is the PIC/S Site Master File (SMF) compulsory and does it contain a list of SOP?

The PIC/S SMF is only a guidance document and it is up to each Regulatory Authority to decide whether the SMF is compulsory or not. The SMF document is available under the page "Publications".

FAQ on GMP by the European Medicines Agency (EMA)

Answers to FAQ on GMP by the European Medicines Agency (EMA) can be found here.