What has changed for initial qualification in GMP Annex 1?
There has been a significant change to the guidance for initial qualification and requalification in Annex 1. Previously, qualification was recommended to be completed to the ISO 14644 series of standards. Now, Annex 1 details the testing that is expected in the initial qualification, then what is needed as part of the requalification.
Now the draft has become live, C2C is getting ready for implementation of Annex 1 to keep our clients compliant.
Are you ready for GMP Annex 1?
Initial qualification of GMP cleanrooms
To help build suitable testing schedules with our clients, we offer two EU GMP Annex 1 compliant qualification packages - GMP and GMP+.
The GMP package contains all the essential testing to qualify that your facility is compliant with EU GMP Annex 1.
The GMP+ package features additional tests that may be required based on your URS and any risk assessments.
Both GMP and GMP+ packages can be customised to meet the exact requirements of your facility.
| EU GMP Annex 1 Testing | GMP | GMP+ |
|---|---|---|
| Airflow measurement - volume and velocity | ✓ | ✓ |
| Airborne particulates | ✓ | ✓ |
| Air pressure difference measurement | ✓ | ✓ |
| Installed filter leakage and integrity testing | ✓ | ✓ |
| Airflow direction and visualisation | ✓ | ✓ |
| Recovery testing | ✓ | ✓ |
| Containment leak testing | ✓ | ✓ |
| Temperature measurement | ✓ | ✓ |
| Relative humidity measurement | ✓ | ✓ |
| Lux level testing | ✓ | |
| Noise level testing | ✓ | |
| Electrostatic dissipation (ESD) testing | ✓ |
The format of our report is in line with EU GMP Annex 1 guidelines, to meet your requirements and those and those of any nominated regulatory body, like the MHRA, HTA, and HFEA. Sample reports are available on request.
Download our guide to GMP qualification and requalification
Regulatory expertise
All validations with a requirement for GMP will have oversight from our dedicated regulatory governance team. This team has over 30 years’ combined experience in GMP & pharmaceutical industries and provides oversight on the entire validation process.
There is a live information flow between the site team and regulatory governance team, which accelerates the timeframe for report delivery. Immediate quality reviews and approvals are performed on live documentation from the engineers.
As all GMP qualification data undergoes an independent quality review, our clients don’t need an external review—saving time and money.
We will work closely with you to make sure you have everything you need for a successful audit.
Qualified and experienced engineers
Each C2C validation engineer is independently qualified to perform cleanroom qualification testing. With comprehensive training and experience, our engineers are proven to be professionally competent in their field.