IPEC e-newsletter - Excipients Insight October 2017 - 16-10-17

 

Inside this issue

     

Third-party certification - Japanese style

Third-party certification of excipients GMP and GDP is fast gaining traction in the industry thanks to the activities of EXCiPACT and other organizations, but it is worth noting that other schemes operate in other parts of the world.

 The GMP Auditing Board for Pharmaceutical Excipients (GAB) is a voluntary certification scheme established by IPEC Japan in 2005 to help ensure that excipients meet high quality standards and meet the requirements of pharmaceutical product developers.

In this system, pharmaceutical companies can request the GAB to perform audits from the point of view of the finished product manufacturer as a customer.

The GAB was set up to provide independent, third-party certification – through the use of site audits – that excipients meet appropriate GMP standards. It uses standards originally developed by IPEC Japan’s GMP Committee in the 1990s and which have latterly been revised to bring them into conformity with the Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients.

The results of these audits are also shared via a scheme known as PEGASS (Pharmaceutical Excipients GMP Audit Sharing System), in which members collectively contract an audit and the audit outcome is shared among them. This allows excipient manufacturers to request GAB to carry out a standardised audit that can then be shared among multiple potential customers.

With thanks to Hiroshi Watanabe of Hinetsu’s Cellulose & Pharmaceutical Excipients Department, who kindly provided English language information on the GAB and PEGASS schemes.

 

 

 

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