Saturday, February 6, 2010

Validation Responsibilities

Colleagues to administer program
- e.g. Technical Services or Site
Validation Committee (SVC)*
– Develop site master validation plan.
– Prepare/execute/approve validation studies.
Manufacturing Operations prepares the batches as though they are
routine production batches.

QA ensures compliance and that documentation and procedures
are in place. Approves protocols and reports.

QC Laboratories - performs testing or contracts validation testing.
Reviews protocols and reports as needed.

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