Commissioning and Qualification
Qualification and commissioning is required for every tool used within a GMP production environment. This is not limited to equipment, but is also valid for utilities like Water For Injection (WFI) and complete cleanroom buildings. Our Qualification department is there to help you minimise the downtime to qualify your production tools like an as-built cleanroom, a critical quality control instrument like TOC analysers, parenteral liquid particle counters, airborne particle counters or even a complete environmental monitoring system.
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
As defined in the FDA Process Validation Guidance, qualification refers to the activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly. 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.
Equipment qualification through DQ, IQ, OQ, PQ practices is a part of Good Manufacturing Practice (GMP), through which manufacturers and laboratories can ensure that their equipment delivers consistent quality. It reduces the margin for errors, so the product quality can be maintained within industry standards or regulatory authority requirements.
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
Cleanroom & Equipment Validation
Hospital Operating Rooms
Equipment Validation HVAC
HVAC Cleanroom Validation
What our clients are saying
As CMO in the biopharmaceutical sector, Novasep Belgium pays special attention to the qualifications of production areas and equipment. For some 10 years now, CMI has been a partner we can rely on for the realisation of these operations.
Flexibility and professionalism are two of CMI’s assets.
It is always nice to work with the motivated CMI team! Everyone is very helpful, enthusiastic and they have a great sense of responsibility. They are always welcome!
CMI is a reliable and professional partner where quality and service are of paramount importance and with whom we will undoubtedly continue to work together.
I would like to thank you again in this way, I have been working here at Novartis (Alcon Couvreur NV) for 17 years. Quality and correctness are our top priorities. Nevertheless we always bring it to a succesfull conclusion, partly through your great support.