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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

    May 5, 2021
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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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