Because contract organizations also must perform internal audits, which typically last one week and occur once a quarter,
the numbers above equate to approximately 26 weeks or half of a year devoted to handling and conducting audits. This amount
of time does not take into account preparation of responses to any potential audit observations or necessary follow-up activities.
To successfully accommodate all of these audits, a contract organization must maintain a full-time contingent. Organizations
must be aware that the time commitment entails more than preparing and hosting audit groups. Each audit could easily take
4 to 5 weeks when considering preparation, hosting functions (both escorting and staging room activities), responses, and
followup.
In addition, the organization must have a unique layer of resources to manage internal cGMP audit programs, which are required
by regulators to ensure that each facility has a process for meeting compliance. Typically, these resources are passed on
to customers as part of the cost for a contracted operation.
Given these expectations, there seems to be an opportunity for industry to work with consortiums such as Rx–360 or the
International Pharmaceutical Excipients Auditing (IPEA) program to share audits and thereby ease overall costs and time tied
to the audits. Moving in the direction of shared audits, however, requires more consistent interpretations and expectations,
general acceptance of responses, and perhaps a certification process.
Companies using contract services must be willing to share their audit programs and compromise on what should be the ideal
approach to assessing GMP compliance of contract organizations. They must agree to a set of criterion to be consistently applied
for auditing and they must be somewhat consistent in their interpretation of the regulations. This would allow contract organizations
to be able to maintain a robust quality system that is suitable for multiple clients. The use of shared audits has been discussed
for quite a while and it seems that Rx–360 and IPEA have started down the road of solving the problem for raw-material suppliers.
Let's hope they agree to continue with the process and help out contract organizations in the same manner.
Susan J. Schniepp is vice-president of quality at OSO Biopharmaceuticals, susan.schniepp@osobio.com
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