Commissioning, Qualification, and Validation (CQV) is one of the most important phases in achieving cGMP and regulatory compliance for a pharmaceutical manufacturing facility.
CQV is a systematic approach to ensuring that facilities, equipment, and processes meet the required quality and regulatory standards. Each phase serves a specific purpose in the lifecycle of the facility or processes.
Here are the key differences between commissioning, qualification, and validation:
Is the initial step in preparing a facility or system for its intended use. It focuses on verifying that equipment and systems are installed correctly and function as designed.
It covers the physical installation, testing, and startup of equipment and systems, ensuring that all components are in place and operate according to specifications.
Commissioning typically occurs before Q&V activities.
The primary documents generated during commissioning are checklists, equipment specifications, and test reports.
Provides documented evidence that a system or equipment works correctly and consistently within established specifications. It ensures that equipment and systems meet predefined performance criteria.
There are three main types of qualifications: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- IQ: IQ verifies that equipment is installed correctly, with all components and accessories in place.
- OQ: OQ confirms that equipment operates within its specified operating ranges and conditions.
- PQ: PQ demonstrates that equipment consistently produces results meeting product requirements in a routine operating environment.
Qualification typically follows commissioning but precedes full validation. Detailed qualification protocols and reports, including test results and acceptance criteria, are generated.
Ensures that the entire process, including equipment, systems, and procedures, consistently produces products that meet quality and regulatory requirements.
There are various types of validation, including process validation, cleaning validation, and analytical method validation, depending on the specific area being validated.
Is a holistic approach that considers all aspects of the process. It examines the entire manufacturing process, including equipment, personnel, materials, and environmental conditions.
Validation usually occurs after qualification and encompasses ongoing monitoring and periodic revalidation.
Generates comprehensive validation protocols and reports that provide evidence of the system’s capability to consistently produce high-quality products.
- Difference Between Calibration and Qualification
- Good Documentation Practice in Commissioning and Qualification
Resource Person: Uchira Lakshan