PS 9100:2002 Pharmaceutical excipients
The application of ISO 9001:2000 GMP guide for pharmaceutical excipients
The Pharmaceutical Quality Group (PQG) of the CQI 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, written in the ICH Q7A style. 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 valuable means of communicating the minimum GMP required of excipients 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.
There are two parts to PS 9100:2002 Pharmaceutical excipients:
- Part 1 includes ISO 9001:2000 and clearly defines the additional GMP requirements for excipients suppliers. The requirements form the basis for a certification scheme for excipients suppliers
- Part 2 provides detailed guidance on GMPs for excipients in an 'ICH' structure, which has been revised following the initial draft issued for comment in December 2000
Development and consultation process
During the consultation process for PS 9100:2002 industry bodies were approached and meetings were held with representatives from bodies such as MCA, CIA, BACS and IPEC. A questionnaire was issued to interested parties during the development of the guide. An initial draft of the PQG excipients GMPs document (now part 2) was issued at the MCA GMP Consultative Committee meeting in October 2000.
As many excipient companies are familiar with ISO 9001, the GMP requirements, which are additional to ISO 9001:2000, have been clearly defined retaining the three levels of GMP to produce part 1 of PS 9100:2002. This also provides the standard for a certification scheme for excipients suppliers.
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