GMP Requalification
Ongoing Performance Qualification requires a repeat of the initial testing on the cleanroom to ensure that its operation continues to meet initial requirements as the facility ages. This is also described as Requalification.
Cleanroom Requalification is usually completed on an annual basis, however the revision of Annex 1 looks to change the requirement to every 6 months for Grade B rooms and Grade A equipment.
It provides an ongoing assurance that facilities and equipment can continue to meet their original specifications.
Tests may include but not be limited to:
- As built/At rest Particle Counts
- Air Volumes and Air Change Rates
- Filter Integrity Testing
- Pressure Differentials
- Temperature and Humidity Levels
- Recovery Rate Testing
- Smoke Visualisation Airflows
- Containment Leak Testing
- Light (Lux) Level Testing
- Sound Level Testing
- Door interlocks Testing
Book a validation appointment
Our cleanroom validation documentation is detailed and auditable. You will receive an interim report on the day of testing, followed by the full report within 10 working days. Reporting is aligned with ISO standards and GMP guidelines to meet your requirements and those of any nominated regulatory body, (e.g. the MHRA).
You can choose from one of our testing packages, or we can build a custom schedule based on your requirements.