Home Ensuring sterile manufacture for EU GMP Annex 1 compliance
Vol. 41 | Vol. 41(1) - January / February 2023 | COLUMN: Quality & Supply Chain Security

Ensuring sterile manufacture for EU GMP Annex 1 compliance

by cyb2025
A. Cluet
cleanroom technology
Contamination Control Strategy
GMP
GMP auditing
Manufacture of Sterile Medicinal Products
pharmaceutical
quality and supply chain security

ANNA CLUET
GMP Consulting area Manager, Rephine, Spain

ABSTRACT

Revised EU GMP Annex 1 requirements (1) for Manufacture of Sterile Medicinal Products come into force in August 2023. Anna Cluet of Rephine sets out the three key areas that life sciences companies must address, along with practical advice as to how to meet the requirements.

In August 2022, revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued, starting the clock for compliance. All but one of the new provisions must be fulfilled by August 2023. The updated requirements, designed to protect and increase confidence in the sterility of these products, are significant and wide-ranging, spanning the Quality system and the manufacturing process itself.

The revised expectations span three key areas, which are set out below along with practical advice on how to fulfil the requirements.

1. CONTAMINATION CONTROL STRATEGY (CCS)
Developing and refining the CCS, which must ensure that consistent standards are upheld end to end across manufacturing operations, will require substantial resources – both now and on an ongoing basis. Here’s how to break that down:

ABOUT THE AUTHOR

Anna Cluet is a highly experienced pharmaceutical consultant and senior auditor at Rephine. Rephine is a firm of deeply experienced GMP auditors which proactively help pharmaceutical companies around the world with their supply-chain quality assurance.

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