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.
validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
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