Unlocking the nuances between Commissioning, Qualification, and Validation is pivotal for precisely navigating regulated industries. Commissioning initiates the process, focusing on equipment and systems installation. Qualification ensures that installations meet predefined specifications and perform as intended. Understanding these distinctions empowers industries to uphold standards rigorously, ensuring safety, efficacy, and regulatory adherence throughout the product lifecycle.
What is commissioning, qualification, and validation?
Commissioning and qualification (C&Q) describe the process for establishing that facilities, systems, equipment, and utilities are suitable for their intended purposes. While it is recognized that the terminologies for the commissioning and qualification process may vary, the terminology used is less important than the approach.
Both are forms of validation. Validation establishes documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. However, the main difference between commissioning and qualification is that the quality unit oversees the qualification process and focuses on the system risk to product quality.
Commissioning can be viewed as an engineering exercise; it is defined as a well-planned, documented, and managed approach to the start-up and turnover of facilities, systems, and equipment to the end user, resulting in a safe and functional environment that meets established design requirements. This includes engineers and construction subcontractors completing work when building, expanding, or renovating a biopharma manufacturing facility. Therefore, commissioning professionals review engineering designs, commission and decommission equipment and utilities, build risk assessment and management programs, and ensure alignment with qualification processes.
Qualification is the terminology that describes a set of independent procedures used to document whether a piece of equipment, system, or process consistently produces results within predefined specifications and requirements of its intended purposes. User needs and various regulatory and safety requirements determine these requirements. It involves a series of activities (e.g., testing, qualification, and documentation) to verify and document the equipment’s performance, functionality, and reliability.
| Commissioning | Qualification |
| Well-planned, documented, and managed engineering approach to the start-up and turnover of facilities, systems, utilities, and equipment to the end-user. | A process to demonstrate and document that the critical manufacturing facilities, systems, utilities, and equipment are suitable for intended purposes. |
| Acceptance criteria emphasize equipment requirements. | Acceptance criteria emphasize product requirements. |
| Commissioning Test Plans usually are in or directed by Commissioning Plan: Setting to Work/Initial Adjustments, Inspections, and Testing. | Testing usually takes the form of “the three Q’s:” Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). |
| Testing usually involves “the three Qs:” Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). | Direct systems are qualified. |
Validation can be defined as generating evidence that processes can consistently produce finished goods meeting quality specifications. This will round out the qualification activities and release that piece of equipment, system, or method for use. Upon the complete validation per MVP, the next focus is to ensure that the validation state is controlled and maintained during routine production. Continued Process Validation (CPV) consists of continuous assessment of parameters and attributes within the control strategy.
PSC Biotech: Partnering for Regulatory Excellence
Grasping the disparities between commissioning, qualification, and validation is essential for maintaining compliance and ensuring the quality of processes and systems in regulated industries. It’s a strategic imperative for industries governed by stringent regulations. Each step is critical – Commissioning sets the foundation, Qualification confirms that systems meet design specifications, and Validation ensures consistent performance in real-world conditions. By discerning these roles and their sequential application, businesses can fortify their compliance frameworks, streamline operations, and ultimately enhance product quality and safety. Mastering these nuanced understandings remains essential as regulatory landscapes evolve for staying ahead of the curve and fostering a culture of excellence within regulated environments.
At PSC Biotech, we understand the complexities of Commissioning, Qualification, and Validation (CQV) in regulated industries. Our comprehensive CQV services ensure your systems and processes meet rigorous industry standards. We provide detailed analyses and validation protocols, guaranteeing that your operations comply with the Food and Drug Administration (FDA), European Commission (EC), and other global regulatory agencies. Whether involved in research and development, clinical trials, quality control, manufacturing, or inspections, PSC Biotech is your trusted partner in establishing, evaluating, and enhancing your CQV processes.
To dive deep into industry best practices, strategic insights, and critical elements for ensuring regulatory compliance and operational excellence in regulated industries, download our whitepaper (Demystifying CQV – Essential insights from compliance) to elevate your standards and surpass industry benchmarks.
