Audit Checklist – Interpretation Guide

On 16 February 2021 the EMA published the first interpretation guide to support the common audit checklist, in cooperation with the members of the joint audit programme.

The interpretations provided in this guide have been written with a view to facilitate the understanding of each indicator, to harmonize expectations and enhance consistency when proceeding with an assessment of a competent authority’s Good Manufacturing Practices (GMP) regulatory compliance programme. A GMP regulatory compliance programme is not limited to the GMP inspection process but also includes components such as the supporting infrastructure of legislative and regulatory requirements, GMP standards, inspection/enforcement resources and procedures, performance standards, alert and crisis system, analytical capability, surveillance programme and quality management systems.

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