Commissioning, Qualification and Validation (CQV) in the life science pharmaceutical and medical device industries define a detailed and science-based process for the specification, design, and verification of new equipment or systems into a production pipeline. In this article, we’re focusing on an over-all CQV instance, involving the launch of a new or significantly modified product is involved rather than focusing on a discrete instance of equipment qualification (IQ/OQ/PQ). In both cases, though, modern CQV practices are informed by a number of industry/regulatory guidelines including:
- ISPE Baseline Guide 5 “Commissioning and Qualification (Second Edition)”
- U.S. FDA “Process Validation: General Principles and Practices”
- ICH Q9 “Quality Risk Management”
- ASTM E 2500 “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment”
The first phase of a comprehensive CQV effort is to finalize the required User Requirement Specifications (URS), and Risk Assessments (RA). Quality Risk Assessments by Subject-Matter-Experts (SMEs) in the process at hand provide risk control strategies and the necessary engineering controls. Once a control strategy has been defined, the Validation Master Plan (VMP) can be developed. The VMP is a high-level document that identifies the amount and sequence of commissioning, verification, and validation activities associated with the Project. This document captures the CQV strategy and is a living document that is revised throughout the project’s lifecycle to maintain the correct strategic approach for achieving regulatory compliance.
Additionally, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) documents are leveraged to accelerate the completion of the project, and they are based on the outcome of the risk assessment (RA). Thus, the Validation Master Plan will incorporate:
- Determine the extent of leveraging permissible based on risk assessment per system.
- Alignment of construction-management inspection test plans and forms.
- Review of completed inspection test plans.
- Review of vendor FAT protocols.
CQV with risk in mind
A science-and-risk-based approach to CQV is a current Good Manufacturing Process (cGMP) requirement. Understanding risk assessments and associated control plans helps define your quality risk management process, which is essential for maintaining quality assurance and adhering to regulatory mandates. Risk Assessments will be critical in determining what aspects of the commissioning and verification effort represent the highest risk. Therefore, your engineers will focus the verification efforts to determine the appropriate level of commissioning and qualification testing and documentation performed for each system and equipment.
CQV engineers review all the project specifications and documentation, focusing on floor plan layouts, equipment and utility piping and instrumentation diagrams, User Requirement Specifications (URS’s), and other documents that specify requirements to be tested/or documented during commissioning. Based on these specifications, the CQV engineers develop a conservative, risk-based approach for commissioning and qualification using the already developed System Impact Assessment (SIA) as a starting point.
Check out other blog articles in our CQV series where we will tell you more about the Validation Master Plan. Then watch for future CQV articles on Phase two of a CQV project – the execution phase performed onsite and remotely. On-site, engineers document and test equipment, facilities, utilities, computer systems, processes, and cleaning. Preparing onsite components is the core component of CQV projects, and we look forward to elucidating this process.
CQV Engineers and Project Managers
PSC Biotech® Commissioning, Qualification, and Validation Engineers and Project Managers are available to:
- Develop the Validation Master Plan.
- Complete Gap and Risk Assessments.
- Perform Pre-Startup Safety Reviews.
- Generate, perform, and document the Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).
- Execute a System Impact Assessment (SIA).
- Provide Installation and operational qualifications (IQ/OQ) for Building Management System (BMS) Systems and Environmental Monitoring Systems Development and assessments for maintenance programs.
- Detailed Operational Qualifications Process Validation (PV).
- SOP development and preventative maintenance implementation.
- Turnover documentation package preparation.
- Compile the CQV Issues Log.
- Finalize the project with a CQV Summary Report (CQVSR).
Furthermore, unless otherwise requested, PSC Biotech assigns a Project Manager to each CQV project. The Project Manager utilizes our exclusively developed Project Tracker (PT) software to maintain an accurate and up-to-date deliverable document status. With years of expertise and regulatory awareness, our engineers execute CQV projects in a highly efficient manner to get your product started as soon as possible. See our project success pages for examples. Contact us for a bespoke assessment and cost estimate.
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