GRC Mott MacDonald has provided validation and regulatory
knowledge to both national and international clients for many
years.
Our validation expertise covers a wide range of pharmaceutical
processes and equipment from preliminary URS compilation to
continued Performance Qualification.
Validation Capabilities:
-
Validation Master Plan
- User Requirement Specification
- Function Specifications/ Design Qualification
- Factory Acceptance Test/Site Acceptance Test
- Commissioning
- Standard Operating Procedures/Change Control
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Process Validation
- Validation Reports