Validation, Calibration & Quality Assurance
PGE is dedicated to ensuring that pharmaceutical facilities reach international specifications according to WHO, GMP, and ISPE standards. Our validation team provides testing, balancing, and commissioning services that are essential for the legal operation of high-stakes medical production environments. By performing rigorous qualifications of cleanrooms and utility systems, we guarantee that the final facility operates within the required biological and technical parameters.
Our quality assurance services include comprehensive Installation Qualification (IQ) and Operational Qualification (OQ) for HVAC systems and critical production equipment. We also conduct specialized temperature mapping studies and BMS (Building Management System) validations to ensure consistent environmental control. These processes are supported by ISO 9001 calibration standards, providing the necessary documentation for regulatory audits and long-term quality management.
- Clean Room Validation: Comprehensive testing and commissioning to certify cleanroom environments.
- System Qualification: Performing IQ and OQ for HVAC systems and critical equipment.
- Environmental Mapping: Conducting temperature mapping studies for warehouses and production zones.
- Automation & Standards: Providing BMS validation and general ISO 9001 calibration services.