The final and the longest stage of validation is Stage 3, which encompasses validation maintenance or verification that the qualified cleaning process continues to perform consistently. It is also known as continued verification process or CPV. Obviously, any changes to the process made since an initial qualification should be evaluated to assess the individual impact of each change as well as the cumulative impact of all changes. While evaluating the changes, it is also important to establish a meaningful verification program which would collect, evaluate, and trend data from each cleaning as well as conduct periodic cleaning verifications to assure that data attained during an original qualification study is representative of the cleaning process performed. Typically, one should see process capability improve as manufacturing operation groups become more proficient in performing qualified Equipment Cleaning Processes (ECP).
The goal of CPV is not just about the confirmation of qualified cleaning methods but, more importantly, to optimize ECP through learning and knowledge management. As the cleaning of equipment is a critical official process, it should be treated as such and be validated in the same way as a manufacturing process would be.
In conclusion, it is evident that a process validation lifecycle approach with its use of statistics is applicable to ECP validation. The risk and knowledge management methodology helps us understand our process (e.g., ECP), the products of the process (e.g., a clean surface), our variables, and ultimately gives us the confidence during commercial production. Finally, utilization of statistics and statistical process controls are essential to effective and efficient ECP post-performance qualification monitoring programs. 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”[i].
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 validation process. 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 site. It provides an indispensable tool for Quality Councils, the use of which have been recently recommended by the FDA. In addition, it provides prompt responses during vendor and regulatory audits, projecting continued compliance and data integrity.
[i] 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
The final and the longest stage of validation is Stage 3, which encompasses validation maintenance or verification that the qualified cleaning process continues to perform consistently. It is also known as continued verification process or CPV.
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.