Excipact - the Certification Scheme for Pharmaceutical Excipients

On average 80% of the volume of each medicinal product are excipients. Few of them are manufactured only for pharmaceutical use; most are destined for the food or cosmetic industry. The potential danger for patient safety should not be neglected and the need for control of excipients suppliers and of the supply chain through the drug manufacturer who is responsible for the medicinal product quality is essential.

Against this background, experts from IPEC Europe and IPEC Americas together with partner associations from PQG (The Pharmaceutical Quality Group), EFCG (European Fine Chemicals Group) and FECC (European Association of Chemical Distributors) have elaborated quality standards for Good Manufacturing Practices and Good Distribution Practices. These GMP and GDP standards which are formulated in the certification programme ExcipactTM should be the basis for audits and their certification. The programme consists of 3 parts:

• Certification Standards for Pharmaceutical Excipients: Good Manufacturing Practices
• Certification Standards for Pharmaceutical Excipients: Good Distribution Practices
• Requirements for Auditor Competency and 3rd  Party Audit Organisations providing Certification

A large number of excipients suppliers have already an ISO 9001 certification which means that they have a quality management system required by the norm. ExcipactTM takes this into consideration in so far as the GMP and GDP aspects which are not covered by ISO 9001 are formulated explicitly. The chapter titles are called:

• Annex to ISO 9001:2008: Additional requirements for GMP for Pharmaceutical Excipients
• Annex to ISO 9001:2008: Additional requirements for GDP for Pharmaceutical Excipients.

The chapter on auditor qualification is based on the ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing. It is called:

• Annex to ISO 19011:2002: Additional Requirements for the Qualification of Auditors and Conducting Audits of Excipients Suppliers.

The chapter on 3rd party audit organisations presents the ISO/IEC 17021:2006 norm and is called:

• Conformity assessment - Requirements for bodies providing certification of excipient management systems.

The standards of ISO norms and GMP/GDP Guidelines in the consolidated ExcipactTM document perfectly complement each other. In this way, excipient manufacturers can be assessed to both ISO and ExcipactTM GMP criteria. The same also applies to the assessment of excipient suppliers and distribution facilities in accordance with ISO and ExcipactTM GDP.

The ExcipactTM document is still in the draft stage (2nd version) and available on the

IPEC Americas website. Soon, ExcipactTM will be finalised and will run as a complete programme. This new certification scheme complements the new directive's requirements to GMP conformity of pharmaceutical excipients through the drug manufacturer (see the following News in this Newsletter) and enables him to fulfil his obligations in this matter.

The ExcipactTM document can be found

here.

On its website, IPEC Americas has published presentation slides which clearly explain the ExcipactTM programme.

Note:
You will get first-hand information about ExcipactTM during the "GMP for Excipients" conference which will take place on 27-28 September 2011 in Barcelona.

Author
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)