Acceptance of Third-Party Audits - Will There Be an Accreditation?

In the past, the subject of the acceptance of so-called third-party GMP audits was brought up time and again. These are audits of manufacturers of active pharmaceutical ingredients (APIs) and excipients conducted by independent third parties.

The most frequently asked question is: Which parties are considered to be independent third parties?

As far back as July 2006, the EMEA issued a clear statement on this question and published a questions-and-answers document. The criteria mentioned in these documents have a key requirement: The QP of the medicinal products manufacturer has to choose and engage this third party, i. e. the organisation meant to perform the audit. Apart from that, it is stressed that:

Conflicts of interest could arise for example from:

A commercial relationship between the organisation performing the audit and the organisation being audited.

In concrete terms, this means that if the audit is commissioned by the API manufacturer or the involved trader himself, independence is not ensured.

Due to the draft for amending Directive 2001/83 presented on 10 December 2008, in the future, i. e. after the final version has come into force (which is expected for 2010), third-party organisations are meant to be nominated or accredited. It has not yet been defined how this accreditation procedure should be handled. Accreditation is often connected to the standard series 17020. However, until today, this series has not had any relevance in the GMP-regulated environment, and in all probability this is not going to change.

In this context, what is meant by accreditation is that third-party organisations are not nominated by standardisation organisations, but by the supervisory medicines authorities of the member states on the basis of the pharmaceutical regulations.
The draft amending the directive says concretely: The first subparagraph of point (f) is replaced by the following:

"(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials. To this end, the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a Member State."

Independently of the question what the concrete implementation of the Directive will look like: The third-party organisations have to be engaged by the manufacturers of medicinal products, i. e. by their QPs, to perform the audit. At present, only few organisations fulfil these requirements. Among them is the audit system of APIC. Specifically for excipients, the IPEC intends to develop a programme in co-operation with the EFCG. The 4th EFCG Conference in Brussels on 13 and 14 May 2009 gives information on this topic.

Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

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