IPEC e-newsletter - Excipients Insight August 2017 - 11-08-17


Inside this issue


IPEC Europe webinar is GDP masterclass

In June IPEC Europe held a webinar intended to provide educational materials on topics that impact excipient supply into and out of Europe.

The programme on Good Distribution Practices for Excipient Supply Chain was presented by Allan Whiston, a 40-year veteran of the pharma industry and former IPEC Europe GDP Committee chair who runs a consultancy that supports both suppliers and users of pharma starting materials.

Whiston explained the importance of GDP in an increasingly globalised and complex market for starting materials, highlighting some of the risks and pitfalls – including examples of patient harm and deaths – that can occur if pharma manufacturers and their supplier partners don't share responsibility for the integrity of the entire supply chain.

He ran through the regulations, standards and guidelines applicable to excipient GDP – including the EU Falsified Medicines Directive, the US Food and Drug Administration Safety and Innovation Act (FDASIA) and the new World Health Organization Good Trade and Distribution Practices Guide, as well as industry standards such as EXCiPACT and ANSI/IPEC/NSF 363.

The most frequently observed problems with supply chains were also highlighted in the webinar, along with recommended measures to minimise them, including the use of the WHO GTDP guide and IPEC Europe's just-updated GDP Guide.




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