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The application of ISO 9001:2000 GMP guide for pharmaceutical excipients
The Pharmaceutical Quality Group (PQG) of the IQA (Institute of Quality Assurance) has produced an application standard - PS 9100:2002 - which defines the application of ISO 9001:2000 to pharmaceutical excipients. The standard has been developed by a team of excipients manufacturers and pharmaceutical companies. It introduces three levels of GMP. Designed as an aid to users, one of the key practical elements in this document is how to assign an appropriate level of GMP for excipients using a risk assessment approach based on patient safety.
PS 9100:2002 is a means of communicating the minimum GMP required of excipient manufacturers supplying the pharmaceutical industry. It is an excellent tool for organisations wanting to assure they are meeting their customers' needs. This promotes a better understanding between the pharmaceutical industry and its suppliers and controls the risk of cost escalation.
The standard acknowledges the current agreed expectations of quality systems as they relate both to GMP and ISO 9001:2000.
PS 9100:2002 is in two parts:
� Part 1 includes ISO 9001:2000 and clearly defines the additional GMP requirements for excipient suppliers. The requirements form the basis for a certification scheme for excipient suppliers.
� Part 2 provides detailed guidance on GMP for excipients in an 'ICH' structure, which has been revised following the initial draft issued for comment in December 2000.
Extracted from the full article which can be found at the IQA Website
This is only an overview/extract of the standard. Users should not rely on its accuracy, but should refer to the complete standard of the appropriate revision.