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Post: Monitoring & Selection of CMOs (Topic#3736)

GYates
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Posts: 5

01-17-08 07:36 AM - Post#4435

Does anyone know of any checklists that might be available for monitoring contract manufacturing organizations? What are things that as a QA person I should be looking out for...other than the review of batch records, analytical results and CoAs?

Is there any documented rule of thumb out there for what sort of acceptance criteria we should use in selecting a CMO?

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