Finalised: The revised EU Annex 1 is published

Recommendation

18/19 June 2024
Copenhagen, Denmark

Environmental Monitoring
Compliant and Reasonable

To cover the current regulatory and technological developments in the manufacture of sterile medicinal products, the EU Commission decided to revise the EU GMP Annex 1 "Manufacture of Sterile Medicinal Products". In particular, the integration of ICH Guidelines Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System) as well as the inclusion of new technological developments made the revision of Annex 1 imperative.

After the launch more than five years ago, the EU Commission presented a first draft for public comment in 2017. More than 6.000 comments led, quite unusually, to a second draft for renewed public comment in 2020.

Long awaited, the final version of Annex 1 was now published on 25 August 2022. Below you can find the first information on deadlines and changes compared to the second draft version from 2020.

Deadlines

• The new Annex 1 will come into force on 25 August 2023, i.e. exactly one year after publication in Eudralex Volume 4. 
• Only with regard to Chapter 8.123 "Product transfer / loading/unloading areas for lyophilizers" the deadline is two years, i. e. until 25 August 2024

Changes compared to the second draft version of 2020

The basic structure of Annex 1 has remained unchanged.

• Scope 
• Principle 
• Pharmaceutical Quality System (PQS) 
• Premises 
• Equipment 
• Utilities 
• Personnel 
• Production and specific technologies 
• Environmental and Process monitoring - instead of Viable and non-viable environmental and process monitoring 
• Quality control (QC) 
• Glossary

Which changes / additions are obvious?

• Annex 1 has become more comprehensive. The number of pages has increased from 52 to 58. 
• The subchapter "Barrier Technologies" in the chapter "Premises" has almost doubled. The topics of background environment, gloves and decontamination methods have been dealt with separately for Isolators and RABS.  
• The subchapters "Form-Fill-Seal (FFS)" and "Blow-Fill-Seal" in the chapter "Production and Specific Technologies" have almost tripled in scope and go into much more detail. 
• In addition, there are further deletions, summaries and new insertions in many chapters, as well as rewordings, which will be dealt with in the following news.

Further information can also be found in a complete comparison of documents.

One of the most important new requirements in the new Annex 1 is a Contamination Control Strategy. Learn more about this new requirement in the Live Online Training Contamination Control - Requirements, Measures and Strategy from 9-11 November.

Source: EudraLex- Volume 4 - Good Manufacturing Practice (GMP) guidelines Manufacture of Sterile Medicinal Products