What are the major changes?
The new EU GMP Annex 1 requirements focus on eliminating the risk of product contamination during the manufacturing process and when the completed product leaves the cleanroom environment. This is all about driving high standards in sterile pharmaceutical manufacturing and protecting patients from any potential ill effects of contamination.
The principles of Quality Risk Management (QRM) and Contamination Control Strategy (CCS) are introduced, giving a holistic approach to contamination control—starting with the design of a cleanroom.
Annex 1 states that “ QRM priorities should include appropriate design of the facility, equipment and processes, followed by the implementation of well-designed procedures” This statement highlights the importance of an effective partnership between the end user and your cleanroom specialist.
The previous Annex 1 has 16 pages and 127 clauses. The newly released Annex 1 has 58 pages and 295 clauses, providing a much more thorough insight into what is expected when manufacturing a sterile product. There have been some significant changes to the guidance for cleanroom construction materials, transfer protocol, airlocks, pressure differentials, and more.
Connect 2 Cleanrooms has the expertise to advise during the design process so that both your process requirements and the new guidance is met. This review process extends to your User Requirement Specification (URS) and everything we do will be evidenced during Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
We are invested in your GMP compliance, and you can trust us to get you through a successful regulatory inspection and customer audits.
Download the EU GMP cleanroom design checklist
All cleanroom projects with a requirement for GMP will have oversight from our dedicated regulatory governance team. This team has over 30 years of combined experience in the GMP and pharmaceutical industries and provides oversight on the entire qualification process.
Our expertise in this area streamlines the design process as we can ensure compliance is considered right from the start to reduce the need for design improvements further down the line. We are happy for designs to be shared with the regulatory authority too and we can support this process by providing documentation and comments in response to any queries.
During IQ, OQ, and PQ, we operate with a live information flow between the on-site validation team and the regulatory governance team, which accelerates the timeframe for report delivery, and provides an independent review of all data generated. Immediate quality reviews and approvals are performed on live documentation from the validation engineers.
When you are being inspected, we will be on standby, working closely with you to make sure you have everything you need for a successful regulatory inspection.
Your GMP cleanroom project
Do you need help designing a cleanroom that must be compliant with EU GMP? Get in touch with Connect 2 Cleanrooms.
Our design and regulatory governance teams have all the expertise you need to make sure your cleanroom is optimized, qualified, and validated according to the relevant sections of EU GMP Guidance. All this and more will be evidenced via DQ, IQ OQ, and PQ to ensure compliance.
To talk to us about a GMP cleanroom project, contact us today.