ANNA CLUET
Pharmaceutical Consultant and Senior Auditor, Rephine, Spain

Abstract

Now that the EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products are live, the expectations of auditors have changed. Implementing fit-for-purpose Contamination Control Strategies is a challenge for many manufacturers. Anna Cluet of Rephine sets out how to identify compliance gaps and offers suggestions as to how to resolve them.

In August, the revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products came into force, with implications for contamination control strategies and, by extension, for plant facilities, equipment, manufacturing processes and Quality systems.

The updated requirements are designed to increase confidence in these products. Now that they are live, the expectations of auditors have adapted accordingly which will have a bearing on audits and their findings from this point on.

In a previous article some months ago, we detailed the confirmed new requirements under Annex 1, in particular relating to a fit-for-purpose Contamination Control Strategy (CCS), and associated policy, to ensure that consistent standards are upheld, end to end, across manufacturing operations.

It is here that many manufacturers have struggled, with some of the main issues (and remedial advice) set out below.

Focus must remain on microbial, particulate and pyrogen contamination
Although the focus of Annex 1 is very clearly on microbial, particulate and pyrogen contaminatio ...