The final and longest validation stage is Stage 3, which encompasses validation maintenance or verification that the qualified cleaning process continues to perform consistently. It is also known as the continued process verification or CPV.
Any changes to the process made since the initial qualification should be evaluated to assess the individual impact of each change and the cumulative impact of all changes. While assessing the changes, it is also important to establish a meaningful verification program that would collect, evaluate, and trend data from each cleaning, as well as conduct periodic cleaning verifications to ensure that data attained during the original qualification study is representative of the cleaning process performed. Typically, process capability improves as manufacturing operation groups become more proficient in performing qualified equipment cleaning processes.
The Goal of Continued Process Verification (CPV)
The goal of CPV is not just to confirm qualified cleaning methods but, more importantly, to optimize equipment cleaning processes (ECP) through learning and knowledge management. As cleaning equipment is a critical official process, it should be treated and validated the same way a manufacturing process would.
A process validation lifecycle approach using statistics applies to ECP validation. The risk management and knowledge management methodologies help us understand our process (e.g., ECP), the products of the process (e.g., a clean surface), and our variables, ultimately giving us confidence during commercial production. Statistics and statistical process controls are essential to effective and efficient ECP post-performance qualification monitoring programs.
A Word of Caution
A word of caution: it is recommended: “that a statistician or person with adequate training in statistical process control techniques develop the data collection plan and statistical methods and procedures used in measuring and evaluating process stability and process capability”. (1)
It is important to note that ValGenesis provides validation lifecycle management solutions that allow companies to perform all these activities and collect validation data and documents within the system that are accessible from a convenient dashboard, which helps locate bottlenecks in the cleaning validation process.
Benefits of Risk-Based Cleaning Validation
The dashboard provides a direct line to tasks, inventory, and work in progress, as well as the validation calendar, validation projects, validation metrics reports, and a 360-degree view of systems and assets by the site. It provides an indispensable tool for quality councils, which the FDA recommends. In addition, it provides prompt responses during vendor and regulatory audits, projecting continued compliance and data integrity. Learn more about the benefits of automated cleaning validation software from ValGenesis.
Editor's note: This blog post is part three of three-part series examining the three stages of cleaning validation. Links to the other posts are listed below.
(1) Guidance for Industry Process Validation: General Principles and Practices, U.S. Food and Drug Administration: January 2011 www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070336.pdf
A process validation lifecycle approach using statistics applies to equipment cleaning process (ECP) validation. Statistical process controls are essential to effective ECP post-performance qualification monitoring programs.
Industry Expert Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. He worked in Production, Quality Assurance, Technical Services and Validation including an Associate Director of Global Pharmaceutical Technology at Shire Pharmaceuticals. He is currently holding a position of Senior Consultant at ConcordiaValsource, LLC. His over the years accomplishments include validation of all of the aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion dollar drug product lines and introduction of new products onto the market. He had published articles and white papers in pharmaceutical professional magazines and textbooks. In addition he had been a presenter at Interphex. He is also very active with PDA participating in several Task force groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation) and 60 (Process Validation). He is leading PDA Water Interest Group. He holds a BS degree in Mechanical and Electrical Engineering Technology from Rochester Institute of Technology.