Unlocking the key changes to Annex 1

The European Union’s good manufacturing practice (GMP) guide for sterile products, known as Annex 1, has been subject to many changes since the first version was published in 1971. Additionally, several updates with partial revisions were issued in 1996, 2003, and 2007 to align classification of cleanrooms and to include guidance on media simulations, bioburden monitoring and capping of vials.

This revised document is a good example of what a harmonised approach can achieve, making a link with the mutual recognition process in progress between the US and EU.

The new scope for Annex 1 was enlarged to include a variety of requirements, noteably: non-sterile products where principles of contamination control could apply. It went through several review processes, where targeted stakeholders gave valuable input from an operational perspective, in terms of technical feasibility and consistency with other guidance, precision and clarity on some of the requirements.

The revised document is a good example of what a harmonised approach can achieve, making a link with the mutual recognition process in progress between the US and EU. As a result, this new Annex 1 proposed in 2017 and updated in 2020 is a completely rebuilt document of 50 pages (16 pages for the current version).

Our Quality Management and Head of Steriles at Recipharm, Vincent Quiles-Pelletier, spoke with Pharmaceutical Technology about the key changes and the impact these could have on the pharmaceutical industry.

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