The latest revision of EU GMP Annex 1 signals a new regulatory paradigm

A new edition of GMP Review has been published (edited by Tim Sandle). In the new edition is a paper by Dr. Sandle, looking at the essential elements of the latest revision of Annex 1 of EU GMP.

The aim of Annex 1 is to set out the minimum standards for the manufacture of sterile products (both aseptically filled and terminally sterilised), which takes place within cleanrooms and barrier devices. There is a major focus within the Annex on the need for a contamination control strategy, purposefully designed for each facility; and for each manufacturer to be using the principles of quality risk management.

While there are several essential points to consider for the contamination control strategy, those that appear to be given the greatest weighting (from this author’s reading of the text) are:

• ·         Maintaining the critical processing zone.
• ·         The aseptic assembly of filling equipment.
• ·         Aseptic connections (these should be sterilized by steam-in-place whenever feasible).
• ·         Special focus on aseptic compounding and mixing.
• ·         The risks abound the replenishment of sterile product, containers and closures.
• ·         Concerns around the removal and cooling of items from heat sterilizers.
• ·         Staging and conveying of sterile primary packaging components.
• ·         Aseptic filling, sealing, transfer of open or partially stoppered vials, including interventions.
• ·         Loading and unloading of a lyophilizer.

It is unsurprising that each of these relate to aseptic processing, the highest-risk area of pharmaceutical manufacturing. 

The reference is:

Sandle, T. (2020) The latest revision of EU GMP Annex 1 signals a new regulatory paradigm, GMP Review, 19 (1): 4-6

For details, contact Tim Sandle.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)