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.
Acknowledgments
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, irwin.s@vreizon.net
,
http://www.ipeainc.com/.
References
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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