Supplier Qualification - Pharmaceutical Technology

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PharmTech Europe

Supplier Qualification
A comparison of comprehensive third-party excipient GMP audit programs.

Pharmaceutical Technology
Volume 36, Issue 10, pp. 124-127


International Pharmaceutical Excipients Auditing (IPEA) was organized in 2001 as a subsidiary of the IPEC-Americas, as a consequence of the poisoning in Haiti that resulted from contaminated Glycerin USP. The objective of IPEA is to reduce the cost of supplier audits through a shared audit program, which can facilitate broader site audit of excipient suppliers for supplier qualification.

Shared audit program. The basic audit is a one-day audit at the excipient manufacturer for a single monographed excipient plus additional time for each additional monographed excipient. The sponsor pays for the audit with the price beginning at US$5500. However for each audit report sold, the sponsor receives a credit of US$500 to be used for the purchase of other services from IPEA. The excipient manufacturer reviews the report for factual accuracy and may append a corrective action plan. Pharmaceutical purchasers of the report remain confidential. To date, The IPEA shared audit program has gained limited acceptance.

ANSI Accredited Certification Program. In 2008, FDA asked IPEA to become accredited by the American National Standards Institute (ANSI) as a conformity body for the operation of an excipient GMP certification program. This accreditation was achieved in April 2010. IPEA certifies conformance to the IPEC–PQG Excipient GMPs, but will soon use the new ANSI Standard NSF/IPEC 363, which is designed for audit assessments. Certification requires a minimum of four man-days at the site with additional time allotted for multiple excipients or processes and off-site operations, including subcontracting. Annual surveillance audits are conducted for one-half the time of the certification audit.

Draft audit reports are reviewed by IPEA for completeness, clarity, the appropriate rating of findings, and to ensure the terminology will be understood by the pharmaceutical reader. The draft is then sent to the excipient manufacturer to review for factual accuracy and so a corrective action plan can be prepared. The draft report and corrective action plan are then submitted to the Certification Board.

The Board is comprised of four members with extensive experience in the excipient or pharmaceutical industry including responsibility for supplier qualification. During a teleconference, the Certification Board reviews the report and corrective action plan and interviews the audit team. If the consensus of the Board is that the site is in substantial conformance to excipient GMPs, the site is recommended for certification.

Certification is founded on the audit and audit report. Auditors must demonstrate extensive prior experience in the performance of GMP audits of component suppliers with an emphasis on excipients. Candidate auditors receive one to three days of training in the certification program, excipient auditing, and conformance expectations. Successful candidates are assigned an excipient audit witnessed by an IPEA executive. The auditor is deemed qualified upon demonstration of appropriate audit skills, rating of observations, and audit report preparation. Qualified auditors are subcontractors who execute an agreement with IPEA that requires their compliance with IPEA standard operating procedures (SOPs) including conflict of interest and maintenance of client confidentiality.

Qualified IPEA auditors conduct certification audits as a member of an audit team. Periodic performance reviews are conducted by an IPEA executive based upon review of their audit reports, participation in Certification Board meetings, and/or witnessing an audit plus their continuing improvement activities.

Certification is paid for by the excipient manufacturer and begins at US$20,000. Annual surveillance audit, priced at 50% of certification, is conducted at the site such that every two years the site has been audited for an equivalent number of days as during the certification audit. To facilitate acceptance of IPEA certification, the audit report is offered to pharmaceutical companies at a nominal cost of $500-750. The majority of the proceeds from sale of audit reports are credited to the excipient manufacturer to defray their surveillance fee.


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