QbD Elements in Pharma: QTPP, CQA, CMA, CPP, and Control Strategy Explained Practically Quick Summary: QbD is not theory. It has 5 clear elements. First we define QTPP – what quality we want for patient. From QTPP we derive CQA – what must be controlled. Then we find CMA (material) and CPP (process) that impact … Read more
Process Analytical Technology (PAT) Techniques: How to Move From Testing Quality to Building Quality in Real-Time Quick Summary: PAT is process analysis in real-time. Instead of taking sample to lab and waiting 2 days for result, PAT measures quality during manufacturing itself. It is a shift from product-centric testing to process-centric understanding. At-line, on-line, in-line … Read more
Knowledge of Quality by Design (QbD) in Pharma: From Concept to Design Space & Control Strategy Quick Summary: You can’t test quality into drug products. Quality should be built in by design. That’s the core of QbD. In this blog, I will explain QbD in simple language – What is QbD, why ICH Q8, Q9, … Read more
Upon meeting the requirements for the initiation of exhibit batches, the Quality Assurance (QA) department shall grant approval to proceed with the execution of the exhibit batch. The execution of exhibit batches will take place, and samples will be collected at various stages of manufacturing and packing, as outlined in the protocol. Any non-conformances identified … Read more
Typically, it is anticipated that process validation should be finalized before the distribution of a finished product intended for sale (prospective validation). In cases where this is not feasible, it may be essential to validate processes during regular production (concurrent validation). Additionally, processes that have been operational for a considerable duration without any major modifications … Read more
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
