Prompts:
1. Company X is currently planning for its Phase 3 global
clinical trial initiation in 2021. One of the regions in which the trial will
take place is in Europe. Investigational medicinal product (IMP) use in Europe
requires a Qualified Person (QP) to review and release (certification) the IMP
for clinical use. Company X is preparing for a QP audit in Q3, 2021. Please
describe how you would prepare the company for its first QP audit from a GMP QA
operations perspective in support of cGMP manufacturing of drug substance and
drug product.
2. Assume that we have filed a BLA, and we expect to have a
Pre-Approval Inspection (PAI) in Q3, 2021. Please explain if you would prepare
the PAI inspection in the same manner as the QP audit, or you would prepare it
differently and why?
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