EU GMP Annex 1: Anne Moreau’s article republished by PDA

We are pleased to highlight an article by Anne Moreau, Head of CQV at Efor, focusing on the implementation of a Contamination Control Strategy (CCS) within the framework of EU GMP Annex 1.

Initially published in La Vague, the A3P journal dedicated to pharmaceutical industry topics, the article was subsequently translated and republished by the Parenteral Drug Association (PDA).

A comprehensive approach to Contamination Control Strategy

The revision of EU GMP Annex 1 has strengthened expectations around contamination prevention and control in sterile manufacturing environments. In this context, a Contamination Control Strategy plays a key role in identifying, assessing and managing contamination risks across operations.

In her article, Anne Moreau explores the challenges involved in developing and implementing an effective and structured CCS. She looks at the different dimensions that need to be considered, from facility and process design to quality systems, monitoring and risk management.

The article also presents several methodologies that can help structure this approach, including those developed by the ECA and PDA, as well as the 5M methodology. The aim is to support a consistent and multidisciplinary approach to contamination control, going beyond simply compiling existing documentation

Read Anne Moreau’s full article translated and republished by PDA (english)

Read Anne Moreau’s article initially published by La Vague (french)