PROCESS VALIDATION Process validation is defined as the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describes … Read more
These are possible approaches to gaining a more systematic, enhanced understanding of the product and process under development. Quality Target Product Profile (QTPP): A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product. The … Read more
WHAT IS QUALITY BY DESIGN? “You can’t test quality into drug products” has been heard for decades – so what’s new? ICH Q8 Pharmaceutical Development focuses on the content of the Module 3.2.P.2 of the Common Technical Document (CTD) and promotes the concept of QbD. It supports knowledge gained through the lifecycle of a product … Read more
