Reprocessing Process repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation,filtration, chromatography, milling). Reworking Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g.,…
The scope of FDA’s regulatory authority is very broad. FDA’s responsibilities are closely related to those of several other government agencies. The following is a list of traditionally recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list.(including) Foods Drugs Biologics Medical Devices Cosmetics…
The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation. Company’s website or in commercial promoting a product or treatment some marketers may say their products are “FDA approved.” But how can you…
GMPs are minimum requirements that companies must meet in the development and execution of acceptable procedures for pharma manufacturingprocesses – from hygienic practices of employees and their work environments, to record keeping to how to handle returns and overages to specifications and testing of in-process and finished products. Data integrity plays a key role…
Most relevant interview questions for freshers and experienced candidate applying for Regulatory Affairs positions in the US market, specifically in the context of generic submission (ANDAs): For Freshers 1. Can you explain what an ANDA is and its significance in the generic drug approval process? 2. How do you envision your role as…
