Supplier Qualification - Pharmaceutical Technology

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PharmTech Europe

Supplier Qualification
A comparison of comprehensive third-party excipient GMP audit programs.

Pharmaceutical Technology
Volume 36, Issue 10, pp. 124-127


EXCiPACT is a voluntary international scheme to provide independent third-party certification of manufacturers, suppliers, and distributors of pharmaceutical excipients worldwide. It aims to ensure patient safety, through supplier quality, while minimizing the overall costs for assessing the excipient supply chain. In early 2009, the European Fine Chemicals Group (EFCG), the International Pharmaceutical Excipients Council (IPEC) Europe, IPEC Americas, the European Association of Chemical Distributors (FECC), and the Pharmaceutical Quality Group (PQG) (UK) formed a project consortium to jointly develop a set of cGMP and current good documentation practice (cGDP) standards for pharmaceutical excipients. Launched as a project of the IPEC Federation, the EXCiPACT Association will become a stand alone not-for-profit organization based in Brussels once commercial activities fully commence.

The EXCiPACT standard is based on the Quality Management System ISO 9001:2008 and provides two annexes to ISO 9001:2008, which cover GMP and GDP requirements for excipients. Excipient manufacturers would be assessed to ISO 9001:2008 and the EXCiPACT GMP annex together, whereas distributors would utilize ISO 9001:2008 and the EXCiPACT GDP Annex. The remaining sections of EXCiPACT cover the requirements for third-party audit organizations, firstly for auditor competency and secondly for quality system requirements for these organizations. The former is based on ISO 19011:2002, Guidelines for Quality and/or Environmental Management System Auditing, whereas the latter is based on ISO/IEC17021:2006, Conformity Assessment—Requirements for Bodies Providing Audit and Certification of Management Systems.

Because the EXCiPACT Association has no auditors, the qualification of EXCiPACT auditors authorized to perform the certification audits is one of the program's most important elements. The EXCiPACT Scheme has two grades of certification: EXCiPACT Auditor and the EXCiPACT Audit Team Leader. These are equivalent to International Register of Certificated Auditors (IRCA) Quality Management Systems (QMS) 2008 certification grades. To be eligible for EXCiPACT Scheme certification, applicants must meet the requirements stated in the EXCiPACT Auditor Competency annex to ISO 19011. Being certified as an IRCA QMS 2008 Auditor or Audit Team Leader meets the basic auditing requirements; however, additional knowledge of excipient manufacturing, GMP, and GDP EXCiPACT Scheme auditing competencies are also required. Both grades require successful demonstration of the application of the fundamental competencies to excipient supplier audits against the EXCiPACT GMP and GDP standards. Demonstration of the additional requirement for at least five years of the IRCA general work experience to be in the pharmaceutical or excipient supplier industry for GMP auditors or three years for GDP auditors for all auditors is also required. If auditors wish to perform GMP and GDP audits then the additional requirement is five years.

For both grades, the successful completion of an EXCiPACT Association approved pharmaceutical excipient supplier auditing course is a prerequisite. This training should be completed within the three-year period immediately prior to application to undertake EXCiPACT certification. Training completed prior to this period may be accepted if evidence is provided of recent, relevant work experience, and currency of their auditing skills, as laid down in IRCA 602. The list of the qualified third-party auditors is published online at

The excipient supplier is the sponsor of the EXCiPACT certification audit. The supplier selects from qualified third-party auditing companies listed on the website. The excipient supplier pays for the audit (approximately US$12,500 [10,000 EUR] for the certification audit and approximately US$6500 [5000 EUR] for the annual surveillance audit) and the certification fee (US$7000 [5500 EUR]).

EXCiPACT Certification is expected to take an additional one to three days depending on the size and complexity of the site when done simultaneously with an ISO 9001:2008 audit. The excipient supplier can choose between a GMP, GDP, or combined audit depending on the activities performed with the scope of the EXCiPACT Certification similar to the ISO 9001:2008 audit. The excipient supplier selects the third-party auditing company, the scope, and the date of the EXCiPACT certification. Surveillance audits are performed every year and a recertification audit every three years.

The audit report is reviewed and approved by the Certification Body so that a decision on certification is made. The EXCiPACT Association acts as arbitrator in the case of disputes between the third-party audit organization and excipient suppliers. The auditee and the Certification Body agree to disclose the audit report and associated corrective action and preventive action (CAPA) plan to parties approved by the auditee. The auditee can share the audit report with any of its customers. The excipient user can verify audit report and certificate with the Certification Body.


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