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FDA pandemic guidance is “unnecessarily burdensome”

By Nick Taylor , 16-Mar-2010
Last updated on 17-Mar-2010 at 12:11 GMT

GSK, Genentech, BIO and PDA have stated that it is “unnecessarily burdensome for pandemic production plans to conform to parts of 21 CFR and requested that the FDA revises its draft guidance.

The four organisations, the only commentators on the document , are unanimous in their belief that some aspects of the draft guidance on production during periods of high absenteeism would burden without benefiting.

In its response the Biotechnology Industry Organization (BIO) stated that requiring the high absenteeism production plans to conform to specific parts of 21 CFR “is unnecessarily burdensome and provides no value to ensuring protection of the public health”.

BIO recommends that plans are designed to support conformance to good manufacturing practices but are maintained in business documents, not the change control system. GlaxoSmithKline (GSK), Genentech and Parenteral Drug Association (PDA) have similar views.

The comment period on the draft guidance closed last week. Comments will now be reviewed before the US Food and Drug Administration (FDA) issues its final guidance.

Test batches

The recommendation that test batches of products should be manufactured under conditions detailed in a company’s plan is also regarded as problematic by all four organisations.

BIO and PDA explain that producing test batches could be expensive, lead to product shortages and inadvertently compromise GMP. GSK and Genentech go into less detail but all the organisations believe practicality issues mean the recommendation should be removed.

Plans developed using prior knowledge, experience and a risk assessment should be sufficient to assure that product quality is maintained, according to BIO and Genentech, removing the need for test batches.

All four organisations also raised issues with the statement: “It is especially important for manufacturers of finished drug products to coordinate their suppliers’ and contractors’ responses to personnel shortages. “ Coordinating this is regarded as unrealistic by the commentators.

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