Position Paper - Implementation of NSF/IPEC/ANSI 363-2014

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Tuesday, March 31, 2015


IPEC-Americas Position Paper
Implementation of the NSF/IPEC/ANSI 363 – 2014 Excipient GMP Standard

The American National Standards Institute (ANSI) excipient Good Manufacturing Practices standard NSF/IPEC/ANSI 363-2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients (NSF/IPEC 363) was approved December 2014 and, since then, has been available for implementation. This paper describes the position of IPEC-Americas on implementation by excipient manufacturers, and use in GMP assessments by excipient users.

The pharmaceutical industry is expected to adopt NSF/IPEC 363 as the GMP standard for assessing and auditing their excipient suppliers. Excipient suppliers and distributors meeting the Standard will be better able to serve pharmaceutical customers expecting compliance.

Per ANSI requirements for the development of a consensus standard, representatives from several organizations including IPEC and FDA were members of the NSF 363 working group.  FDA may use NSF/IPEC 363 as either Guidance or regulation for excipient GMP.

IPEC-Americas recognizes that implementation may depend on the:

• state of conformance to the IPEC-PQG GMP Guide for Pharmaceutical Excipients
• complexity of the excipient produced
• number of excipients produced
• resources available for upgrading the Quality Management System

For these reasons IPEC-Americas is not suggesting a specific deadline for implementation by suppliers. Nevertheless, it is the position of IPEC-Americas that each excipient supplier should have an implementation plan in place by the end of the third quarter 2015 which should define their implementation timeframe for each manufacturing site.

Excipient manufacturers should:

1. Review the NSF/IPEC 363 Standard.
2. Identify the activities required for conformance to each applicable clause of the Standard.
3. Identify those clauses where the Quality Management System is not in conformance. This may be accomplished through gap assessment.
4. Assemble a team from all affected areas, such as production, quality, maintenance, marketing, etc. to work on resolving identified gaps.
5. Prioritize the activities necessary to fully implement the excipient GMP Standard.
6. Establish a project plan with a timeline for each activity and assign a responsible individual or area.
7. Review the project plan with management and receive approval to proceed.

Excipient distributors should assess their operations to identify applicable requirements. Where the distributor provides excipients in unopened manufacturers’ packaging, there will be fewer applicable requirements. However, distributors that repackage excipients should consider the actions in the list above for manufacturers.

Excipient users (pharmaceutical customers) should implement NSF/IPEC 363 for the excipient supplier qualification. It is suggested that procedures be updated so that by fourth quarter 2015 excipient suppliers will be expected to have an implementation plan, with acceptable timelines.

IPEC-Americas is revising the excipient GMP audit guide to reflect the NSF/IPEC 363 Standard. The IPEC-PQG excipient GMP guide is being similarly revised as a “how to Guide” for implementing the NSF/IPEC 363 Standard and will clarify the requirements of the Standard with direction and examples.

The revised guidelines will provide assistance in understanding the requirements of the excipient GMP Standard. While these guides are under revision, interested parties should take advantage of the workshops and webinars offered by IPEC-Americas to aid in their implementation of NSF/IPEC 363.