IPEA Excipient GMP Certification Program - Pharmaceutical Technology

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IPEA Excipient GMP Certification Program
The author describes the new IPEA excipient good-manufacturing-practice certification program that is now ANSI accredited. This article is part of a special issue on excipients and solid dosage.

Pharmaceutical Technology
Issue 34, pp. s40-s42

Qualification of IPEA Certification Auditors

Another concern to involved parties is the qualification of those individuals involved in the Excipient GMP Conformance Certification program. The program is administered by two industry experts, each of whom have been involved with excipient quality systems and GMP requirements for more than 25 years. These individuals have participated in the development of excipient GMPs since 1991 and continue with the development of an ANSI excipient GMP standard. Their careers in the industry include experience with both excipient makers and pharmaceutical users.

Recent business developments in the industry have significantly increased the availability of seasoned, experienced GMP auditors that IPEA has trained and qualified. IPEA contract auditors are skilled industry and/or government individuals who have maintained an interest in assuring the quality and regulatory conformance of excipients and who have received training in the Excipient GMP Conformance Certification program and excipient GMP expectations. IPEA auditor qualification concludes with their successful completion of an audit under the supervision of an IPEA executive.

The IPEA Certification Board consists of contract consultants whose careers have included relevant Quality-Unit experience or management responsibility. These individuals receive additional training by IPEA in the certification program, including certification criteria and the responsibilities of the Certification Board.

ANSI expects program operation and certification requirements to be made available upon request. To address this expectation, IPEA has publically disclosed program requirements by posting all applicable procedures, policies, and forms to the IPEA website ( http://www.ipeainc.com/).

The path to accreditation

IPEA initiated the path to accreditation with the development of an accreditation plan in October 2008 followed by the development of program documentation. Accreditation by ANSI began in August 2009 with their acceptance of an extensive application. The next step was an initial ANSI Documentation Assessment conducted in the IPEA headquarters by an ANSI assessor who reviewed the Quality Manual, procedures, policies, forms, and associated records.

With the successful completion of the Documentation Assessment, ANSI proceeded to the Witness Assessment. The ANSI assessor joined a two-person Certification Audit Team and observed the first day of a two-day on-site certification audit of Grace Davison (Baltimore, MD) for their Silicon Dioxide NF. (Note: This site was subsequently the first to be certified by IPEA.) Again, the assessor was satisfied with the operation of the Certification Program and submitted two reports, one for each assessment, to the ANSI Evaluation Task Group.

The Evaluation Task Group reviewed the reports and submitted their recommendation to accredit the IPEA certification program to the ANSI Accreditation Board. Their decision was announced in late April 2010 and the program has been officially accredited.

Benefits to industry

The excipient and pharmaceutical industry can now benefit from the IPEA certification program through assurance of the conformance of excipient suppliers to GMP requirements without the need for a site audit. The benefit to the excipient supplier is a reduction in their resources to host frequent customer audits and assurance that the excipient GMP audit is conducted against appropriate GMP conformance expectations. The supplier also has an opportunity to review the certification audit report to assure the accuracy of observations and can provide a corrective action plan if warranted.

The pharmaceutical customer benefits from assuring excipient-supplier GMP conformance without the expense of a site audit. More importantly, the assessment by the IPEA certification auditors, which is more extensive than excipient manufacturers typically allow for a pharmaceutical audit, results in additional confidence in the appropriateness of the excipient GMP quality system. IPEA's annual surveillance audit and biannual recertification assure the excipient site maintains their conformance to GMP. The pharmaceutical user also has an opportunity to review the Certification Audit Report at nominal cost for confirmation of substantial conformance to excipient GMP with approximately 80% of the proceeds used to defray the certification maintenance costs.

As noted earlier, IPEA is represented on the committee that is currently developing an ANSI standard for excipient GMP. NSF, an ANSI standards development body, has organized a committee of experts for this purpose in accordance with ANSI procedures. IPEA will certify conformance to the ANSI excipient GMP standard upon its adoption.


IPEA would like to thank FDA for encouraging IPEA to develop the Excipient GMP Conformance Certification program and to become ANSI accredited. It was with continuing encouragement and support by FDA that IPEA maintained the effort to become accredited.

Irwin Silverstein is vice-president and chief operating officer of International Pharmaceutical Excipients Auditing (IPEA), a subsidiary of the International Pharmaceutical Excipients Council (IPEC), tel. 732.463.8710,
, http://www.ipeainc.com/.


1. ISO/ISE Guide 65 General Requirements for Bodies Operating Product Certification Systems, 1996.

2. IPEC–PQG, Joint Good Manufacturing Practices Guide for Pharmaceutical Excipients, 2006.


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