Proper design and development of the process, the subsequent process criticality assessment and the following process validation approach needs the involvement of different departments (R&D, engineering, QA, production, QC, etc.). Only through a rational evaluation of all this knowledge it is possible to discern the critical process parameters and design the adequate validation strategy. Process validation strategy is aimed at showing the consistency of the critical operations and process robustness between different batches produced in the final industrial scale and environment. Number of batches and extended sampling plan should be well stablished to allow checking the behaviour of the process under all the expected variables.
After this initial validation exercise, process behaviour is monitored batch to batch and reviewed, and trend analysis is performed periodically to be sure that the process is kept in the validation state.
Approach towards these topics may show differences between different actors in the pharmaceutical industry (i.e. API manufacturers, finished product manufacturers or excipients manufacturers) according to the inherent characteristics of the related processes and facilities: from batch manufacturing in multiproduct and multifunction facilities to continuous process in dedicated fit-for-purpose facilities, including legacy products and new developed products.
In this webinar we will share the accumulated experience of having carried out hundreds of audits of APIs, finished products and excipients, in which evaluation of process criticality assessment and process validation approach is a hot topic. This should include:
Technical staff from API, and Pharmaceutical industry.