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Validation for the 21st Century

Presented at: BIO International Convention, Atlanta, GA, May 21, 2009

The presentation explains and discusses the differences between the original FDA Guidance on Process Validation of 1978 and the new Draft Guidance issued in November 2008. The old approach to validation, including the preparation of, usually, three conformance batches at full scale, is contrasted with the new, life-cycle approach.

There will be three stages in the new procedure, process design, process qualification and continued process verification. Each of these stages is discussed in detail, along with the need for additional monitoring, sampling and testing in Stages 3. Extensive statistical analysis of the process data will be required, which may place a strain on QC capability.

The presentation includes a summary of the responses so far received by the FDA from firms and industrial associations, including the suggestion that the guidance should now be handed over to an ICH working party for harmonization with other ICH guidelines.