Every GMP tool, utility, and cleanroom requires rigorous qualification. Our team minimizes your downtime by efficiently validating everything from WFI systems and “as-built” cleanrooms to TOC analyzers and environmental monitoring systems. We ensure your critical assets are compliant, operational, and ready for production.
Commissioning and Qualification
Every GMP tool, utility, and cleanroom requires rigorous qualification. Our team minimizes your downtime by efficiently validating everything from WFI systems and "as-built" cleanrooms to TOC analyzers and environmental monitoring systems. We ensure your critical assets are compliant, operational, and ready for production.
Commissioning and Qualification
Qualification & Commissioning services for:
- Sterilizers (Steam Autoclave & ethylene oxide)
- Freeze dryer & pasteurizer
- Sterilization tunnels and Ovens
- Temperature controlled units(Freezers, fridges, blood bank, cold room)
- Climate chambers (oven, incubator)
- Washer-disinfectors
- Laminar flow and bio-safety cabinets
- Fumehoods
- Warehouse & storage areas
Commissioning
Commissioning is a systematic approach to the start-up and turnover of facilities, systems, and equipment to end-users and ensuring that user requirements and design specifications are met (International Society of Pharmaceutical Engineering {ISPE}, 2007). Activities within this phase may include design reviews, factory acceptance testing, installation verification, and functional testing. Summary reports are generated at the conclusion of commissioning activities and include an overview of the results and any deviations encountered during testing. Commissioning, if well documented, may be leveraged to reduce or eliminate qualification testing.
Qualification
According to ISPE Baseline Guide 5 approach, systems, and equipment determined to have a direct impact on product quality are typically qualified using Installation and Operational Qualifications. While systems with an indirect impact on product quality may only be commissioned. Under an ASTM E2500 approach, testing typically considered as part of IQ/OQ is referred to as verification. ASTM E2500 emphasizes utilizing a science-and-risk-based approach in order to focus the verification activities on critical aspects of the system. Commissioning activities, if performed to cGMP standards may be leveraged during the Qualification phase as they verified the system is suitable for its intended use and demonstrated proper functionality.
