Frequently asked GMP question: How should active substance auditors be qualified?

From time to time we receive "GMP questions" from ECA Members. On a regular basis we will provide answers by using the official statements of regulatory authorities. The follwoing question has been answered by EMA in a Q&A section:

How should active substance auditors be qualified?

Auditors should have sufficient scientific, technical and other experience to enable them to perform an adequate and thorough audit of the active substance manufacturer, as related to the planned scope of the audit. Where a proposed auditor lacks an appropriate level of direct experience in the field of active substance manufacture, he or she should undergo a documented training and assessment programme in the areas that are relevant to the audit, taking into account the auditor's anticipated role in the audit and the technologies that are likely to be encountered during the audit. Auditors must also be trained and assessed in their knowledge and understanding of EU GMP part II and in auditing techniques in general. The training and assessment should be fully documented.

The qualification and experience of contracted auditors are the same as the requirements for the manufacturing-authorisation holder's own auditors.

Source: European Medicine Agency

Tip: The APIC certified Auditor training programme is an internationally recognised auditor qualification scheme. Within one week participants have to join an ICH Q7 Compliance training course and an auditor training course. An exam is part of the certification scheme. Please find more information at

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