Evaluation Guide for GMP Regulatory Compliance Program – Audit Checklist

14 March 2023 – the EMA published revision 3 of the audit checklist for the GMP regulatory compliance program.

The checklist must be used for the assessment/evaluation of GMP regulatory compliance program as regards active pharmaceutical ingredients and medicinal products. This checklist is used as a high level document. It is meant to detail the “WHAT” and not the “HOW”. The “HOW” is expected to be covered in a lower level document such as a guidance document or a procedure.

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