Annex 1: The road to compliance
The long-awaited revised Annex 1 on the manufacture of sterile medicinal products, was published by the European Commission on August 25, 2022. The new version has been expanded considerably and includes a significant shift towards risk management principles and implementation of a Contamination Control Strategy (CCS).
Manufacturers are now required to have a clear rationale for preventing contamination of finished products by micro-organism, particulate or pyrogens, by designing, validating and monitoring a comprehensive, facility wide strategy. The new Annex 1 entered into force on August 25, 2023*. Are you compliant?
*except for point 8.123 (lyophilizers) which is postponed until 25 August 2024.
Background:
- The aseptic filling of a sterile medicinal product must be carried out in a controlled environment. The relevant part of the EU GMP Guidelines for this type of manufacturing is the document’s Annex 1.
- After a long revision period, the revised Annex 1 was finally published by the European Commission on 25 August 2022.
- This revision is a complete rewrite of the annex and was a joint EU, PIC/S and WHO project, with U.S. FDA personnel actively involved.
What are the main changes?
The aim is to move away from sterility based mainly on an audit of the final process or product, towards detailed process knowledge and control of all potential sources of contamination.
Key concepts are:
- Quality risk management (QRM) approach Contamination Control Strategy (CCS)
- Continuous monitoring approach
- Pharmaceutical Quality System
Testing, validations and microbiology expert support
Eurofins BioPharma Product Testing (BPT) is the largest network of harmonised GMP worldwide. We have more than 40 GMP laboratories, 30 of which in Europe, that have been already implementing Annex 1 revision in their own microbiology labs and supported several clients in their journey to compliance.
Our internal microbiology technical councils have defined best practices and shared harmonised approaches to support the specific validation and quality control requirements of new Annex 1 in the following areas:
- Environmental monitoring
- Cleaning & disinfection validation
- Disinfectant validation studies and quality controls
- Water and steam systems – qualification and monitoring
- Gases and Compressed Air
- Aseptic Processing Validation
- Sterilisation and Depyrogenation
- Raw Materials and Packaging
- Single-Use Systems
- Quality Control
Contact us at information@bpt.eurofinseu.com
