Continuous performance verification is the act of verifying the correct parameters are upheld using a monitoring tool, such as data logger, continuously throughout the supply chain. It is a term that’s arisen from regulations by the FDA (USA) and the EMEA (European Medicines Agency) and is a significant factor for many pharmaceutical and biotechnology manufacturers.
The U.S Food and Drug Administration published their ‘Guidance for Industry – Process Validation: General Principles and Practices’ in 2011, which gives key recommendations (Section , Stage 3) for Continued Process Verification. It states:
‘The goal of the third validation stage is continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems for detecting unplanned departures from the process as designed is essential to accomplish this goal. Adherence to the CGMP requirements, specifically, the collection and evaluation of information and data about the performance of the process, will allow detection of undesired process variability.’
The EMEA states;
Traditionally, process validation has demonstrated the reproducibility of a process, based primarily on repeatability and testing of the end product. Using Continuous Quality Verification (CQV), processes are continuously verified as being capable of providing the desired product quality as an alternative to reliance on data generated from a few production lots.
Implementation of CQV involves the continuous monitoring, evaluation and adjustment, as necessary, of the process. CQV moves away from validation as a discrete exercise and is consistent with a lifecycle approach to process validation.
Continuous process validation can be conducted with ease using Wessex Power wireless temperature monitoring solutions. Every solution is tailored to the client and their verification needs; comprised of wireless data loggers and software. Their wireless capabilities enable non-stop data to be transmitted to any electronic device with a wireless connection, such as a mobile phone or computer without interruption. From the data logger’s installation to throughout the supply chain, such as in transport or storage, it will continuously transmit data. Our data solutions can also include alarms that alert the user whenever a threshold is breached, and automatic PDF reporting for quick response and data sharing.
Our wireless temperature monitoring solutions include reporting, alarm management and are commissioned with GxP documentation. Software services including proof of 21 CFR Part 11 compliance and accuracies verified with calibration certificates.
Learn more about our wireless monitoring solutions by calling +44 (0)1929 459 459 or make a general enquiry.