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. Take a look at the table on the right to compare what’s included with each package.
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.
| 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 | ✓ |
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.
MEET OUR REGULATORY GOVERNANCE TEAM
Qualified and experienced engineers
Each Angstrom 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.
Download our guide to GMP qualification and requalification
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Our cleanroom validation documentation is detailed and auditable. You will receive an interim report on the day of testing, followed readily by the full report. Reporting is aligned with ISO standards and GMP guidelines to meet your requirements and those of any nominated regulatory body, like the MHRA.
You can choose from one of our testing packages, or we can build a custom schedule based on your requirements.
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