Commissioning and Qualification (C&Q) applies Good Engineering Practice (GEP) into design and construction and integrates GMP qualification principles.
General Principles & Practices
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). The objective is to comply with GMP regulations to ensure the product’s safety and quality.
The “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment (ASTM E2500)” applies Good Engineering Practice (GEP) to commissioning and qualification of process facilities regarding the production of medicinal products.
Commissioning and Qualification combines GMP system qualification principles, into design, construction, assembly, installation, testing and documentation to 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
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
Build C&Q in the process facility setup!
Process line and process facility qualification (e.g. Sterile Fill Line Equipment) for sterile pharmaceutical manufacturing is one of the most critical assets. For aseptic manufacturing in compliance with cGMP, EU GMP Guide Annex 1, FDA guidance, and ISO 14644 principles are applicable.
