Validation is the process of establishing documented evidence demonstrating that a procedure, process, or activity carried out in testing and production consistently maintains the desired level of compliance, thereby ensuring product quality at all times.
In the pharmaceutical industry, validation assures that processes consistently deliver expected results, beyond just final testing. We maintain well-documented systems & SOPs for all stages – design, engineering, installation, and FQPs – to meet stringent regulatory requirements.
Our validation scope includes:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Performance Qualification (PQ)
Our in-house, dedicated teams perform validation in accordance with ISO 14644 and other relevant standards to meet regulatory needs of USFDA, UKMHRA, MCC, and others.
Cleanroom Validation Tests include:
- ACPH Test
- Pressure Difference Test
- HEPA or ULPA Filter Integrity/Efficiency Test (PAO Test)
- Particle Count (Airborne Non-viable)
- Recovery Test
- Shoot-off Test
- Air Flow Pattern Test
- Temperature & Humidity Measurements
- Noise Level Measurement
