EXCiPACT TM SIGNS AGREEMENTS WITH CERTIFICATION BODIES TO UNDERTAKE CERTIFIED AUDITS OF PHARMACEUTICAL EXCIPIENT SUPPLIERS

The EXCiPACTTM Association – a project of the IPEC Federation - is pleased to announce that it has completed Framework Agreements with two internationally-recognised Certification Bodies (CBs) for the certification of the manufacture and distribution of pharmaceutical excipients according to the EXCiPACTTM Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) Certification Standards. The CBs are mdc medical device certification GmbH / blue inspection body GmbH1 and SGS2.

Auditors employed by these organisations who have completed the formal EXCiPACTTM Training Programme will now undertake EXCiPACT-witnessed pilot audits of pharmaceutical excipient suppliers. The independent witnesses will allow EXCiPACTTM to verify that the standards and the auditor training have been defined and implemented correctly. Once each auditor has been assessed satisfactorily then they will become a fully qualified Certified Auditor under the EXCiPACTTM Certification Scheme.

The EXCiPACTTM Scheme has been made available at a time when the regulators in the EU and USA require the holder of the marketing authorization for medicines to ensure that appropriate GMP and GDP is applied to the manufacture and distribution of both APIs and excipients. The requirement for site audit by FDA and EMA continues to be pressed for pharmaceutical excipients and as a result their suppliers must be prepared to receive increasing numbers of audits. EXCiPACTTM Certification can help to avoid some of these additional audits in a cost-effective manner. EXCiPACTTM expects to register other Certifying Bodies and Auditors in the near future.

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