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


Inside this issue


New IPEC-PQG GMP guide set for publication shortly

IPEC Europe's GMP Revision Task Force has completed an updated version of the IPEC-PQG GMP Guide, bringing the document fully in line with the latest thinking on Good Manufacturing Practice requirements for pharmaceutical excipients. The new guide should be officially published and available shortly.

The quality of excipients is critical to assure the safety, quality and efficacy of medicines. Excipients have a wide range of applications and are essential components of the drug product formulation. Characteristics that excipients impart to formulated drug products include cosmetic appearance, stability and delivery of the active ingredient. Therefore, applying appropriate GMP principles to excipients is essential.

The new 2017 version of the IPEC-PQG GMP Guide replaces the 2006 edition. While the fundamental principles of GMP have not changed in the intervening period, there have been important changes in the way adherence to GMP should be achieved.

In particular, there is an increased regulatory emphasis on risk-assessment. The EU Directive on Falsified Medicines (2011/62/EU) lays out a requirement for pharmaceutical manufacturers to carry out a risk-assessment for excipients used in pharmaceutical products to determine the appropriate level of GMP used to produce them. In turn, that led to the publication of the EU Guidelines on risk assessment for excipients (2015/C 95/02) which came into force on 21 March 2016. This risk assessment thinking should also be applied by Excipient manufacturers as they implement GMP.

The guide also needed to be updated to take into account the EXCiPACT standard, against which excipient suppliers can be certified to provide assurance that they are operating in conformance with excipient GMP. Third-party certification against EXCiPACT is increasingly being adopted by excipient producers and sought by pharmaceutical manufacturers.

"We needed to bring the guidance up to date with new requirements such as risk assessment, and also make sure that it is fully aligned with the EXCiPACT standard," said Kevin McGlue, IPEC Europe's Revision Task Force Leader for the new guide. "Users of the new guide will be brought fully up-to-date with the latest GMP thinking for excipients."

Other updates to the guide include the provision of greater detail on documentation – taking into account the shift to from paper to electronic record-keeping over the last decade – as well as refined and expanded guidance about corrective actions, sample retention, packaging etc.

The guide is an important accompaniment to EXCiPACT's international standard as well as NSF/IPEC/ANSI 363-2014 standard in the US, according to McGlue. It provides guidance for groups just starting with GMP, as well as for those who may not want to go down the certification route, and also gives initial assistance for those just starting to think about standards and certification in the context of pharmaceutical excipients.




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