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When does QA Oversight Begin in Drug Development?

Discussion in 'Other Quality and Business Related Topics' started by Janet Stanish, May 5, 2021.

  1. Janet Stanish

    Janet Stanish New Member

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    As our company grows, so has our QA organization. As we wade through drug development, we are unsure of when QA oversight truly begins. We feel that we have a grasp of QA oversight during clinical work, beginning with Phase 1, but what about pre-clinical activities? What, if any, does QA oversight look like during the pre-clinical phase? I have millions of questions, from batch documentation review to the need for Quality Agreements with GLP labs, etc.
     

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