Excipient-Certification Standards Presented for Comment

The International Pharmaceutical Excipients Council (IPEC) is soliciting public comment about a draft plan for the independent certification of manufacturers and suppliers of pharmaceutical excipients. The document is the second draft of the “

” set of standards, and the authors sent it to industry stakeholders for review.

The plan is based on the ISO 9001 quality-management system standard and provides annexes describing good manufacturing practice (GMP) and good distribution practice (GDP) requirements for pharmaceutical excipients. The document recommends that excipient manufacturers be evaluated for adherence to ISO 9001 and the Excipact GMP annex, and that distributors be assessed for their adherence to ISO 9001 and the Excipact GDP annex. The document’s GMP and GDP annexes list requirements for various items, including quality-management systems, documentation control, personnel management, resource management, identification, process validation, management review, and traceability.

A separate section of Excipact lists competency and quality-system requirements for third-party audit organizations. The competency requirements are based on ISO 19011, “Guidelines for Quality or Environmental Management System Auditing,” and the quality-system requirements are based on ISO 17021, “Conformity Assessment—Requirements for Bodies Providing Audit and Certification of Management Systems.”

US and European law does not yet require manufacturers of pharmaceutical excipients to adhere to GMP, but recent incidences of contaminated materials have led regulators and legislators in both regions to focus on these ingredients. Because excipient quality affects patients’ safety, GMP and GDP standards are necessary to ensure the ingredients’ quality and purity, and to secure the supply chain, according to the Excipact draft.

The Excipact standards are intended to reduce the cost of reliable qualification for suppliers and manufacturers, according to the authors’

about the document. The standard is specific to excipients, and the authors are seeking all stakeholders’ acceptance. The standard also is intended to become a highly visible certification that allows audit organizations and certified excipient suppliers to be authenticated.

The European Fine Chemicals Group, the Federation of European Chemical Distributors, the Pharmaceutical Quality Group, and IPEC collaborated to develop the current draft. Comments must be submitted to Iain Moore, product and quality-assurance manager of Croda Europe, by Jun. 30, 2011.