What is EU GMP Annex 1? Annex 1 of EU GMP provides specific guidance on the manufacture of sterile medicinal products. The latest version of the guidance has been published and will come into force on August 25th, 2023.
This new version is substantially different to the previous version and includes specific guidance on the training and behaviour of your cleanroom staff. The purpose of this article is to help Micronclean's customers understand this guidance.
This article forms part of a series of posts from Micronclean that will look at the key parts of EU GMP Annex 1, explain the key requirements to remain compliant with Annex 1 and then suggest how Micronclean's products and services could help you remain compliant, and follow best practice.
So, what does Annex 1 say about your staff working in a Cleanroom?
Annex 1 states that every manufacturer must ensure that there are sufficient appropriate personnel, suitably qualified, trained and experienced in the manufacture and testing of sterile products. This same requirement also applies to people who are employed to clean the cleanroom. The guidance also states that the training a person receives should involve gowning qualification with periodic re-assessment against written cleanroom gowning and hand washing procedures.
Annex 1 states that only the minimum required number of people should be present in the cleanroom, that movement within the cleanroom show be slow and methodical and that high levels of personal hygiene are also required.
As a result, the new version of Annex 1 makes it clear that the person in the cleanroom is just as important in the contamination control strategy, as the cleanroom itself, the cleanroom clothing, the consumables used and the manufacturing process itself.
So, how can Micronclean help with your staff?
As the UKs leading supplier of reusable cleanroom garments, we have a vast experience to draw on, having supplied garments into the UK cleanroom marketplace since the mid 1980’s. This means that not only are we able to advise on the best combination of garments and consumables for you to use, but we can advise on acceptable gowning techniques and hygiene policies. For instance, using a BeMicron coverall, or changing the way a conventional coverall is folded, can help with aseptic gowning techniques.
As a company we acknowledge that every customers circumstances are different, and as a result a simple “one size fits all” approach is not the best way forward. Each circumstance needs to be treated on its individual merits.
How Micronclean can help you with your overall compliance to Annex 1?
Micronclean is unique in the UK cleanroom market in that we have an in-house R&D team which includes Microbiologists who can assist you with your garment requirements alongside your cleaning and disinfection needs.
For more information about how we can help you please contact us.
UK Cleanroom Sales Manager