Simple way to understanding of CQA-Critical Quality Attributes and CPP-Critical Process Parameters
As a Biopharma professional understanding of any process of drug manufacturing is very important. furthermore, important is to Product quality and Patient safety. With aim of to provide consistent quality of drug, any industry run their business. "Product Quality" is top tagline but how we can achieve it? Product quality can achieve by designing the quality. What? Yes First step is QbD(Quality by Design). What is QbD? QbD is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.(ICH Q8 R2). Let's Understand the definition: First of all Firm should have pre-defined objective means what type of product quality is required. The second thing we should have understanding of Product and Process. The third thing we should have a sound scientific rationale. Once we have above mentioned three things, then we can do the quality risk manag...