What are the consequences if an API manufacturer has not been audited?

The Danish Medicines Agency offers some very helpful Question & Answer documents on their webpage. One of the questions frequently asked is: What are the consequences if an API manufacturer has not been audited?

The answer of the Danish Medicines Agency is:

As of 17 December 2005, medicinal products that contain an active pharmaceutical ingredient supplied by an unaudited manufacturer are quarantined on inspection until the API manufacturer has been audited.

A second interesting question is: What documentation is required to substantiate that the active pharmaceutical ingredient has been manufactured in accordance with GMP?

The answer of the Danish Medicines Agency is:

The pharmaceutical manufacturer must keep audit reports readily available on all its API manufacturers (in respect of manufacturing, packaging, repackaging, mixing, labelling, relabelling and supplementary labelling). The audit reports will be used when the Danish Medicines Agency performs an inspection on site at the premises of the pharmaceutical manufacturer.

An evaluation of the API manufacturer based on questionnaires, analysis results, or other form of certification such as a GMP certificate issued by an EU regulatory authority does not provide the same level of assurance of GMP compliance as an audit at the premises of the API manufacturer.  However, the Danish Medicines Agency will accept the manufacturer to include the above-mentioned documentation in the adoption of a risk-assessment strategy for GMP audit of the concerned API manufacturer, e.g. scheduling the first audit and audit intervals. An audit must have been completed, unless it has been postponed based on a risk-assessment strategy.

Source: Danish Medicines Agency

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