IPEC e-newsletter - Excipients Insight April 2017 - 30-04-17


Inside this issue


GDP Committee delivers new IPEC Federation GDP guide

IPEC Europe's GDP committee has completed its revision of the Good Distribution Practice (GDP) Guide which will now be published as an official IPEC Federation document, as the 2017 edition.

The original guide – published in 2006 - was in need of updating to bring it into conformity with current practices and regulatory requirements and is now fully aligned with the World Health Organization's Good Trade and Distribution Practices (GTDP) for Pharmaceutical Starting Materials, document, which came onto effect in 2016.

"The original guide was based on WHO GTDP Guide published in 2003, but this document itself was not under consideration for update by the WHO until approached by IPEC Europe," said Eckart Kraemer, who chairs the GDP committee.

The new version will help excipient suppliers make their systems more robust in order to satisfy the expectations of customers and meet regulatory requirements, while excipient users will benefit from the many additions and clarifications made to the original text, he added.

Among the key changes to the guide is the inclusion of quality risk management principles, which were previously missing but have become standard in several industries, as well as specific and more detailed guidance on supplier management to help ensure authenticity, traceability and security of the supply chain.

Other important amendments include clarification of the need for an independent quality unit, extension of the CAPA requirements to include preventive actions and verification of effectiveness, detailing the practices that should be implemented to avoid cross-contamination and mix-up and clarifying that carriers used for transportation should be approved according to a written procedure - unless the carrier has been selected by the customer.

Overall, the update has provided greater detail and functionality to the document as a whole, for example by including integrated links to associated documents such as guides and standards, said Kraemer. Examples based on practical experience are provided to facilitate the application of GDP. However, alternative approaches may be acceptable.

Critically, the GDP committee worked with the WHO in developing an update to their document thus allowing the GDP guide to be republished in alignment with the current WHO GTDP document.

Where GMP relevant activities are described, reference to the IPEC-PQG GMP Guide – also just updated (see our article here) – and other publications and standards such as the EXCiPACT GMP and GDP standards (2012) and NSF/IPEC/ANSI 363 have been made in order to maintain consistency.

The guide will be available for free download in the near future.





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