COMMISSIONING & QUALIFICATION



WHAT IS C and Q?

Commissioning and Qualification
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Commissioning and Qualification is a very detailed process that requires an understanding of several disciplines: engineering, quality assurance, manufacturing and FDA and International regulatory agency compliance in order to place equipment and systems into use. 

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The process of Commissioning and Qualifying equipment and systems is a complex series of events that all integrate to provide a validated (quality) product or process.
The steps involved in the process include the following:


  • Define the quality target product profile (QTPP)
  • Establishment of critical quality attributes (CQAs) 
  • Define the critical process parameters (CPPs)
  • Definethe user requirement specification (URS)
  • Definition of the functional design specification (FDS)
  • Design The project   
  • Enhanced design review (EDR)
  • Development of the validation master plan (VMP)
  • Project construction
  • Project commissioning
  • Installation qualification (IQ)
  • Operational qualification (OQ)


HOW DO WE

Engage With You and Your Company?
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  • Work with client project teams to define and coordinate the scope and project schedule for the CQV activities.   
  • Engage in project design review activities 
  • Generate perspective User Requirement Specifications (URS) and Functional Requirement Specifications (FDS) for equipment and systems 
  • Write and execute IQ/OQ and PQ protocols for new and existing equipment, facility utilities, and manufacturing processes. 
  • Write up and document deviations and non-conformance and work to resolve and perform the close out efforts required until there is a resolution. 
  • Provide facility and process equipment startup support 
  • Provide automation systems qualification 

CONTACT US

to schedule a consultation
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