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The Relationship Between QA,
QC and GMP
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The most important characteristics of FMD vaccines are safety, sterility and efficacy, and it is the first responsibility of a manufacturer to ensure that each batch of product conforms to or exceeds the standards required by national or international regulatory authorities.
Safety tests are usually performed in vivo, using the whole vaccine inoculated
into susceptible animals. Assurance of minimum potency is required, which
can be assessed by a variety of serological and/or animal challenge procedures
(Pay and Hingley, 1992).
In 'emergency' situations retrospective testing is allowed following the
release of the vaccine if in-process quality assurance can be given.
Previously, it was possible to reach these standards solely by testing of the final product but this is no longer considered adequate for a number of reasons. These include the statistical limitations of the final product tests which are a consequence of the maximum quantity of final product which can be realistically tested. Thus, the use of FMD vaccines released only by this approach carries the risk that the vaccine will not be as effective as claimed and may even be responsible for disease due to incompletely inactivated vaccine virus(es).
An alternative approach is to use a full Quality Assurance System in which everything associated with the production and release of the vaccine is controlled. Quality Assurance should operate at all stages of an FMD vaccine production process, including final product testing, and ensures the safety and efficacy of the vaccine even before it has been submitted to the final product tests.
FMD vaccines should have a mininum shelf-life of one year if stored at 4ºC.
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