The new Annex 1 of EU Good Manufacturing Practice (GMP) provides specific guidance on the manufacture of sterile, medicinal products. These requirements provide additional focus on eliminating the risk of product contamination during the manufacturing process.
How can Angstrom Technology help?
If you're new to the pharmaceutical industry, you may think you can build a cleanroom and apply for a regulatory license with no prior work required. However, compliance is necessary throughout the whole lifecycle of the cleanroom. EU GMP Annex 1 introduced the principles of a Contamination Control Strategy (CCS) to assist businesses in working towards compliance. The CCS should be a living document relevant to all aspects of your processes and facility. Our in-house GMP team can help you with this, and here’s how:
EU GMP Annex 1 details the requirement for using consumables such as neutral detergent to ensure surface cleanliness prior to disinfection and for residue removal, as well as the mandatory use of socks, sterile goggles and sterile gowning gloves in higher-grade cleanrooms, to ensure minimal human contamination.
Testing & Requalification
Annex 1 details the minimum testing requirements as well as the maximum time interval between testing.
The maximum time interval for requalification for A & B areas is 6 months, and C & D areas is 12 months. Please note the word maximum here, you can always qualify more often but not less often.
Additional testing may be required, and a risk assessment should be performed to determine additional requirements - that's where we can help!
Compliance During Use
Once the cleanroom is qualified, does the room stay compliant? No!
Compliance cannot be guaranteed if a cleanroom is not used correctly, using best practices and following procedures.
- Ensure your team is adequately trained.
- Ensure your team is appropriately gowned.
- Ensure a validated cleaning and disinfection programme is in place.
- Ensure microbial environmental monitoring is performed.
- Ensure fixtures, fittings and furniture must be constructed from cleanroom-suitable materials and be resistant to the cleaning agents you plan to use.
Want to know more? Book a space on our GMP cleanroom operator training course!
When regulations change, does your facility meet the new requirements? A gap analysis audit is a useful tool to determine whether the changes to regulations have impacted your facility.
A mix of internal and external audits will provide an understanding of how your facility is used, and the interaction with your processes, along with a fresh perspective and potential broader knowledge of regulatory requirements.
For newly built cleanrooms or an upgrade to an existing facility, you should expect a regulatory inspection before moving into production.
A mock inspection will help you prepare, and you should expect the inspector to scrutinise the full cleanroom validation package, so make sure you have it ready, and it is suitable to share.
Are You Ready to Ensure EU GMP Annex 1 Compliance?
In summary, you must consider compliance before starting any cleanroom project, through to the design, installation, operation, servicing and requalification stages and during continued cleanroom use, to ensure the room functions as required.
The upcoming EU GMP Annex 1 Compliance is fast-approaching, but we can still offer our help and guidance to support you in your compliance. Contact our GMP team to book a consultancy appointment and ensure you are doing everything you can to remain compliant after the changes imposed by Annex 1.
Alternatively, book a spot on our dedicated GMP cleanroom operator training course to stay up to date with cleanroom best practices!