by Neeraj Joshi
Commissioning, qualification, and validation (CQV) describes an integrated quality assurance process for the performance of highly technical and deeply regulated facilities in the life sciences industry. It provides the documented evidence needed to verify that utilities, systems, and equipment are designed, installed, and operated as required. CQV is performed in accordance with industry and regulatory standards and is an exceptional tool for evaluating a manufacturing operation’s potential life cycle.
Most CQV efforts follow the guidelines established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Adoption of ICH’s consensus-based guidelines by regulators around the globe is critical to realizing the benefits of safe, effective, and high-quality medicines for patients as well as for industry. The Food and Drug Administration (FDA) plays a major role in the development and dissemination of each of the ICH guidelines.
The successful provision of CQV services is predicated on mutual trust between the engineer and the client. Confidentiality is mandatory in this hyper-competitive market sector, as is complete objectivity on the part of the evaluation team, whose job it is to support quality programs that are unique to each client and project.
The CQV process has three distinct phases:
- Commissioning is a documented engineering process to confirm that systems (mechanical, electrical, plumbing, etc.) are installed and performing according to design intent and manufacturer’s recommendations, with a focus on maintainability, testability, and accessibility.
- Qualification occurs in tandem with commissioning and involves the application of a scientific and risk-based approach to verify adequate installation, operation, and performance with respect to a specific manufacturing process. Delivery of a robust and compliant qualification program is essential for the successful implementation of a product’s life cycle.
- Validation is the collection and evaluation of data from the process design stage to commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products. This activity is required by the Good Manufacturing Practices.
Until recently, CQV was largely a paper-based process. A single paper copy report, sometimes upward of 2,000 pages, would be scrutinized by a group of reviewers. The process was sluggish and vulnerable to misinterpretation and loss of critical data through wear and tear of repeated handling. In an industry where speed to market and microscopic precision are paramount, this is a major bottleneck.
The benefits to using e-validation tools are many and improve workflow efficiencies while promoting uniformity in data collection and report formatting. Using e-validation tools, teams can collaboratively review documents, allowing for real-time dialogue while supporting remote working. The integrated document management systems in these platforms are a major improvement over the conventional report. The use of these platforms provides more standardized CQV documents, higher fidelity in the data collected throughout the process, and a smoother process resulting in significant time savings.
Due in part to elevated client expectations, demand for workflow efficiencies among practitioners, software advancements, and sustainability initiatives, cloud-based electronic validation platforms have become the industry gold standard for collection and documentation of CQV-related data. As the industry continues to adopt these tools, the increased collaboration promises to unlock new efficiencies in the CQV process.
Neeraj Joshi
Neeraj Joshi is a CQV project lead at DPS Group.
