Commissioning & Qualification
Scope of C&Q
Commissioning & Qualification (C&Q) focusses on the identification on critical design elements (CDEs) in terms of critical quality attributes (CQAs) and critical process parameters (CPPs) to ensure product quality and safety.
Objective of C&Q
The objective of C&Q is to apply Good Engineering Practice (GEP) and the Standard Guide on Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment (ASTM E2500) to establish qualification principles into design, construction, assembly, installation, testing and documentation into manufacturing systems.
Main C&Q Phases
- Design Review and Design Qualification
- C&Q Testing and Documentation
- C&Q Acceptance and Release
Main C&Q Requirements
- URS
- System Classification
- System Risk Assessment
- Design Review and Design Qualification
- C&Q Testing and Documentation
- C&Q Acceptance and Release
System Risk Assessment
- Identify system risks in terms of product and process quality
- Evaluate and analyze the identified risks
- Define risk controls in terms of CDEs (critical design elements)
- Define system alarms
- Link testing activities to CQAs and CPPs