Standards and Guidelines for pharmaceutical Excipients

The publication of the first American National Standard for pharmaceutical excipients (NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients) just recently underlines again the importance of GMP compliance, not only for APIs and finished drug products, but also for excipients being used in pharmaceutical manufacturing.

But, what is in fact the difference between a ‘guideline’ and a ‘standard’ and which of those currently apply for excipients?

A guideline (as e.g. taken from an IPEC guideline foreword) typically represents a “voluntary guidance for the pharmaceutical excipient industry and the contents should not be interpreted as regulatory requirements. Alternative approaches to those described in this guide may be implemented”. A guideline is therefore not a mandatory document or approach. In contrast to that, a standard represents a mandatory document for suppliers aiming to be certified according to such a standard (=being independently assessed to be in compliance with the standard).

For excipients currently two standards exist, which are closely interrelated i.e. the EXCiPACT GMP / GDP standard (representing the basis for the certification according to the EXCiPACT voluntary certification scheme), which has to be read in conjunction with ISO standard 9001 and the NSF/IPEC/ANSI 363 standard, which represents a self-standing standard document. Both excipient standards have been developed in partnership with the IPEC and other organizations as well as with input from pharmaceutical excipient experts from regulatory, industry and academics.

Excipient Guidelines:

Collection of Websites with GMP Non-compliance Data

Due to the global sourcing of pharmaceutical materials such as packaging materials & containers, excipients, drug substances (APIs) and drug products (Medicinal products), the knowledge about the GMP compliance status of manufacturers is of crucial importance for responsible persons in the supply chain. Enclosed is an updated list of websites providing useful and up-to-date information about GMP Non-compliances of manufacturers:

Major GxP Events I & II/2015