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Unannounced audits for GMP+ FSA suppliers

As part of the FCA certification, the unannounced audit is since 2008 a part of the certification cycle intended for companies with a production activity.


On July 30, 2015 GMP+ International announced the introduction, albeit on a voluntary basis, of a system of unannounced audits within the GMP+ FSA certification.


In the context of the mutual recognition agreement concluded between OVOCOM and GMP+ International, it was agreed that FCA certified companies, from 01/07/2016, may only purchase products originating from GMP+ FSA certified suppliers holding a GMP+ FSA certificate on which the scope “unannounced audits” is mentioned. It is important to note that the system of unannounced audits is only applicable to GMP+ FSA certified suppliers with at least one production activity.


The FCA certified company is obliged to communicate this requirement to his GMP+ FSA certified suppliers, and to verify whether they comply with this requirement. This can be done simply by accessing the GMP+ International site and verifying whether the supplier actually has the correct scope.


This additional qualification for GMP+ FSA operators is included in document ‘BT-02 : Purchase : General Provisions’.


Some other changes have also been included in this document.

15 Oct 2015


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