EMEA Evaluates Use of GMP-Compliant API Production

In the period between May 2005 and May 2006 a survey was performed by the EEA GMP inspectorates on behalf the EU Commission. The whole was coordinated by the EMEA. The goal was to examine how manufacturing authorisation holders fulfil the requirement of using only active substances as starting materials that have been manufactured in accordance with GMP (article 46f/50f of the guideline 2001/83 (2)/EC). The results and the Aide Memoire used for the survey were now published by the EMEA.

The basis of the evaluation consisted in 517 submitted reports of 24 national supervisory authorities. The results of 42 inspections of API manufacturers conducted between 2003 and 2006 outside of the project were also included.

The results show that most of the inspected companies have established audit programmes for their API suppliers. However, not all of them meet the requirements and show deficiencies. Above all the programmes of small companies do not always fulfil the expectations. There were also companies to which the conduct of an audit was refused by the supplier. A problem that arises frequently when only small quantities of active substances are purchased.

Most of the supplier audits were conducted by qualified auditors. Only in few cases problems occurred, especially where external auditors had been engaged.

With a third of the inspected sites there were, however, discrepancies regarding traceability and the proof that the active substances used actually came from the designated manufacturer. There were deficiencies regarding change control processes, re-labelling and misleading documentation.

Apart from the manufacturers of medicinal products, traders and brokers were also examined within the scopeof the evaluation. Here, substantial problems were revealed. In some cases e. g. traders themselves created certificates of analysis, in one case wrong information was given in the certificate regarding the origin of the active ingredient. Regarding the supplier audits conducted by the traders themselves doubts were expressed regarding a conflict of interests (for example lack of independence). The outcome revealed more detailed information on the activities of the traders and brokers as well as on the problems deriving from them, in particular the loss of traceability. The report points out that these results received special attention with regard to the new initiative for the establishment of a legal initiative for fighting counterfeit medicines.

The evaluation shows that the manufacturers of medicinal products are aware of their duties and take measures to fulfil the requirements. It is to be expected that also in future inspections the topic of supplier qualification will be dealt with intensively.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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