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Certification Standards for Pharmaceutical Excipient Suppliers

Requirements for Auditor Competency and Third-Party Organisations Providing Certification of the Management System - 2021

If the appropriate quality standards are not followed, excipients may pose a hazard to patient safety. 

Thus, the requirement to have a robust quality system in place that assures the quality and purity of excipients remains manufacturer through to user, adopt suitable standards that are capable of independent verification.

Legislators and regulatory authorities in both Europe and the USA have addressed and continue to address the weaknesses in the application of GMP and GDP to pharmaceutical excipients to minimise patient risk. A common theme in these regulatory requirements is that the excipient user has to have knowledge of the management systems and GMP used to manufacture and/or the GDP used to distribute the excipient. 

As a result, excipient supplier sites could be asked to host hundreds of extra audits. 

In recognition of these issues the authorities have clearly stated that the excipient user (drug product manufacturer) can utilise third party audit organisations to perform the audits.

Thus, a third-party audit organisation may perform the audit, so reducing the burden in time and resources for both the excipient user and excipient supplier. 

However, for such third-party audit organisations to be accepted within the industry both the standard used to assess excipient suppliers and the competency of their auditors has to be addressed.

EXCiPACT Certification Scheme for excipient suppliers  was launched in 2012. 

Many excipient suppliers are already registered to the Quality Management System standard, ISO 9001 which provides an excellent framework on which to build and develop systems suitable for the manufacture and supply of pharmaceutical excipients.

ISO 9001, therefore, forms the basis for these EXCiPACT GMP, GDP and GWP standards as three annexes to ISO 9001:2015. 

This allows excipient suppliers to be assessed to ISO an imperative, particularly as events with fraudulent claims of pharmaceutical raw material purity have resulted in so many human tragedies.

Those suppliers which do not hold ISO 9001 certification will find the US National Standard (GMP) for Pharmaceutical Excipients NSF/IPEC/ANSI 363-2016) is an alternative approach: this standard is also based on the original IPEC-PQG GMP Guide 2006. 

With this edition of the EXCiPACT GMP, GDP and GWP standards, the current editions of the IPEC-PQG GMP Guide, the IPEC GDP Guide and NSF/IPEC/ANSI 363 are fully aligned.

The remaining sections of this 2021 EXCiPACT publication cover ther equirements for third party audit organisations covering both auditor competency and quality system requirements for these organisations.

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