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ICH Q7 Rules and guidance for Pharmaceutical Manufacturers and Distributors (orange guide) 2007

Guidance on Good Manufacturing practice (GMP)

GMP for Starting Materials

(To be read in conjunction with Part II of the EC Guide to GMP.)

From 30 October 2005, new Community requirements obliged manufacturing authorisation holders to use as starting materials only active substances that have been manufactured in accordance with GMP.

This includes both total and partial manufacture, as well as any repackaging or re-labelling activities carried out by a distributor or broker. Herb APIs used as active substances for traditional herbal medicinal products as defined in Directive 2004/24/EC will also be required to comply with the new requirements.

The amending legislation gives powers to the competent authorities in Member States to carry out inspections at the premises of manufacturers of such materials, the marketing authorisation (MA) holder and any laboratories employed by the MA holder. These inspections will be conducted by the competent authority, may be unannounced and may be carried out at the request of an API manufacturer, another Member State, the Commission, or the European Medicines Agency (EMEA). The competent authority will be empowered to inspect premises, take samples and examine documents.

The responsibility for confirming that the active substances in use have been manufactured in accordance with GMP rests with the holder of the manufacturing authorisation in the EU. The primary means by which EU regulatory authorities will supervise compliance with the requirement for active substances to be manufactured in accordance with GMP will be through review of audit reports during inspections of manufacturing authorisation holders.

Audits of API manufacturers should be performed by suitably trained auditors. During inspections the competence of auditors will be assessed and if not deemed appropriate this will be raised as an issue.

The new Community requirements do not require licensing of API manufacturers. However, a report will be provided to the manufacturer or MA holder who has undergone the inspection and, where relevant, a certificate of GMP compliance issued. Certificates will be entered on a central Community database, as will be any failures in compliance.