The American National Standard for Excipient GMP

The author reviews significant changes to GMP for excipients in the forthcoming American National Standard, including a risk-based approach to excipient manufacture, why new requirements were proposed, and their potential impact to excipient manufacturers.
Mar 01, 2012
Volume 2012 Supplement, Issue 2

Between September 2010 and December 2011, a joint committee organized by NSF International worked to complete a draft of NSF 363, a new American National Standard for excipient GMP. The draft standard, Good Manufacturing Practices (GMP) for Pharmaceutical Excipients, has completed the public comment period and a final version is to be balloted shortly (1). The new standard aims to establish industry-wide GMP requirements for the manufacture of excipients.

NSF 363 was developed based on the joint International Pharmaceutical Excipient Council and the Pharmaceutical Quality Group (IPEC–PQG) Good Manufacturing Practices Guide for Pharmaceutical Excipients (2). The suggestions expressed in the IPEC–PQG guide were reworked into requirements of the standard. Other IPEC guides are referenced in NSF 363 to clarify how industry can achieve conformance to the standard.

Background and importance of an excipient GMP standard

NSF is an independent, not-for-profit, nongovernmental organization and an Accredited Standards Developer of the American National Standard Institute (ANSI). ANSI is a private, nonprofit organization that administers and coordinates the US voluntary standardization and conformity assessment systems. ANSI is the US representative to the International Organization for Standardization (ISO). American National Standards are developed in conformance with the ANSI Essential Requirements to ensure that standards are developed through participation by those directly and materially affected without financial or organizational membership barriers, a lack of dominance by a single interest category, individual, or organization, and a balance of interests (3).

Of relevance to the industry is the fact that the National Technology Transfer and Advancement Act of 1996 requires that federal agencies adopt private-sector standards, particularly those developed by standards-developing organizations, wherever possible, in lieu of creating proprietary, nonconsensus standards. Further, the US Office of Management and Budget's Circular A119 provides for "Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities." As a result, FDA may adopt the ANSI standard GMP regulations for excipient ingredients manufactured for use in pharmaceutical dosage forms intended for US domestic markets.

The NSF joint committee organized to prepare the excipient GMP standard, designated as NSF 363, is comprised of representatives of excipient manufacturers, pharmaceutical users, and the general interests of the industry, including FDA, academia, and public health organizations. The final draft of NSF 363 was completed in the fourth quarter 2011 and was made available for public comment at the end of the year. The 45-day public comment period ended in January 2012, and the NSF joint committee reviewed the comments to the draft standard. Revisions to NSF 363 are in progress with final approval of the standard is expected to occur in the second quarter of 2012. Following the joint committee's approval, the standard will be considered by NSF's Council of Public Health Consultants with final approval by ANSI's Board of Standards Review. If approved as expected, the standard will be published by the end of 2012.

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