Annex 1 Revisions

Cleanrooms, and controlled environments play a critical role in maintaining high levels of cleanliness and sterility within various industries, such as electronics, pharmaceuticals, healthcare and biotechnology. These controlled environments are subject to specific guidelines and standards to ensure the quality of the products and processes with minimal contamination risks. Annex 1 Revisions have been published by the European Commission.

Annex 1 Revisions

The Annex 1 Revisions, of the European Union’s Good Manufacturing Practice (GMP) guidelines has brought about significant changes that will reverberate throughout the cleanroom industry. The changes outlined must be effective by the 25th of August, 2023.

Summary of Changes in Revised EU GMP Annex 1:

Scope, Principle, and Glossary: The scope of the annex has been expanded to include additional areas beyond sterile products, such as:

• Contamination control strategy
• Design of premises
• Cleanroom classification
• Qualification
• Validation
• Monitoring
• Personnel gowning

References to the importance of applying Quality Risk Management (QRM) principles have been added, and special requirements for sterile products are categorised into three categories. A glossary has been introduced to clarify terminology and avoid ambiguities. Pharmaceutical Quality System (PQS): The section lists specific requirements for sterile product manufacture, emphasising:

• Risk management
• Knowledge and process understanding
• Non-conformity management
• Management responsibility
• Access to information

Non-conformity investigation related to sterility or microbiological load is highlighted. Premises: The Annex 1 Revisions premises chapter now explicitly uses the term “cleanrooms” and outlines different classes and classification requirements. The importance of “at rest” and “operational” states is emphasised, and requirements for total particle concentration and allowable microbial contamination are slightly changed. Periodic re-qualification of cleanrooms and clean air equipment is emphasised, and the use of Restricted Access Barrier Systems (RABS) as a barrier technology is introduced. The section also contains a comprehensive description of airlocks, airflow patterns, and air pressure requirements is provided. A new requirement was also added – the ability to observe Class A and B areas from the outside. Equipment: The revised chapter outlines the need for an equipment design description, precautions, and cleaning and sterilisation processes.

When do changes come into affect?

The EU GMP Annex 1 Revisions for the manufacturing of sterile products will be effective on the 25th of August, 2023.

Annex 1 Revisions Guides

Want to learn how to Validate Protective Clean Room Garments? Read the DuPont guide, here. Read about the Practice Gowning Implications for Annex 1 in the Alsico guide, here.