CAPA (Corrective Action & Preventive Action) is an area that we talk about often, mainly because it’s still such a big issue for companies. This time, we’re looking at a step-by-step process that, if done well, should help any company to get a good result from their CAPA process. A STEP-BY-STEP CAPA PROCESSThe key thing …
Pharmaceutical Quality System Elements & Change Management System As per ICH Q10 The elements described below might be, required in part under regional GMP regulations. However, the Q10 model’s intent is to enhance these elements in order to promote the lifecycle approach to product quality. These four elements are: • Process performance and product quality monitoring …
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