The ISPE PQLI Good Practice Guide: Part 4 – Process Performance and Product Quality Monitoring will give suggestions, considerations, and approaches for establishing a process performance and product quality monitoring system in line with the expectations of ICH Q10, Pharmaceutical Quality System.
The Guide will emphasize the importance of an established and well-justified control strategy from which a process performance and product quality monitoring system can evolve.
The Guide will discuss the opportunities for establishing a process performance and product quality monitoring system for a product developed using the “enhanced, quality by design approach.”
Product stewardship is a relatively new concept, which is emerging from industry. It is being realized in different ways by different companies to meet the common goal of maintaining and applying product knowledge consistently, to:
The use of statistical approaches will be discussed as well as considerations for managing process models in the commercial manufacturing environment. Potential roles for the position of Product Quality Steward will be suggested for establishing and evaluating the data from a process performance and product quality monitoring system, and also serving as a focus for product quality.
Relatively short documents are being written to provide considerations for practical application of a lifecycle approach to process validation to follow recommendations given in FDA’s Guidance for Industry – Process Validation: General Principles and Practices, January 2011. These documents will discuss application of concepts and provide examples. Highest priority is being given to topics perceived as most significantly changed compared with previous process validation expectations including:
Topic 1: Determining and Justifying the Number of Process Validation Batches
Topic 2: Applying Continued Process Verification Expectations to New and Existing Products