New audit tools
Table I: Matrix of Applicability.
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Similar to IPEC's 2006 GDP guide, the new audit guide opens with a Matrix of Applicability table (see Table I). An auditor
can use the table to identify aspects of GDPs that apply to the distribution operation being assessed. Activities may range
from simple to more complex GMP operations, ranging from the transportation of packaged excipients to repackaging and packaging
from bulk excipient. The auditor identifies the applicability symbol reflecting the activities conducted at the distributor,
represented by a Greek letter that corresponds with the warehouse or distribution activity. The auditor can then assemble
a customized audit guide by identifying those sections indicated by the Greek letter that are applicable to the distributor
to be assessed.
The auditor can create a customized checklist by selecting from more than 250 open-ended questions that cover 96 audit categories
within 13 audit sections. The audit sections correspond with the GDP guide. A customized checklist facilitates a thorough
audit of distribution activities. Depending on the range of activities conducted at a distributor's facility, a site audit
can range from a half-day to multiple days.
Futher, a site assessment of the distributor is an expectation of FDA for the qualification of distributors for the same reason
that site audits are expected for the qualification of an excipient manufacturer. The alternative, which is out of favor at
FDA, is a paper audit. A paper audit relies on properly worded questions that solicit truthful, thorough answers from the
distributor. Regardless of the veracity of the responses to a paper audit, such audits do not provide an adequate assessment
of the risk to excipient quality from the environment, equipment, or improper excipient storage conditions.
Although a distributor audit establishes the distributor's conformance to GDPs, certain distributor activities, such as repackaging
and storage of bulk excipient, also must conform to applicable GMPs. The IPEC–Americas audit guide provides questions for
the assessor that also target these relevant GMP operations conducted at a distributor's site.
In 2001, IPEC formed an independent auditing group known as International Pharmaceutical Excipients Auditing (IPEA) to facilitate
physical audits of excipient manufacturers and distributors. At the urging of FDA, IPEA developed an Excipient GMP Conformance
Certification Program. In 2010, this program was accredited by the American National Standards Institute (ANSI). Also in 2010,
four excipient manufacturing sites in two countries were audited for conforming to the provisions of the IPEA program and
two sites completed the certification process. Upon the approval of an ANSI standard for Excipient GMP, currently under development,
certification to excipient GMP will be based on this standard.
The updated IPEC-Americas GDP audit guide provides product-conformity assessment bodies with a foundation for developing a
similar ANSI accredited excipient GDP certification program. Companies can develop objective criteria along with expectations
for substantial conformance to GDPs that cover the range of industry distribution activities. With such procedures in-place,
an ANSI accredited third-party audit provider, with the approval of ANSI, can expand its certification activities to include
distributor certification to GDPs.
The demands of the pharmaceutical industry will determine whether certification of distributors is beneficial to supplier
qualification and to the enhancement of supply-chain security. Most likely, industry can look forward not only to the certification
of distributors but also to the development of an American National Standard for GDPs.
Acknowledgment
The author wishes to acknowledge that the GDP audit guide is a product of the IPEC–Americas GMP Committee.
Irwin Silverstein is vice-president and chief operating officer of International Pharmaceutical Excipients Auditing (IPEA), a subsidiary of
IPEC, tel. 732.463.8710, irwin.s@verizon.net
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http://www.ipeainc.com/.
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