WebMar 3, 2024 · However, there are five objectives that nearly all companies strive to accomplish through materials management. These objectives, known as the “Five R’s of … Establishing the relationship between raw material attributes and product CQA is the key first step in designing control strategy. It is important to start thinking about control strategy for raw materials during early development and as product knowledge evolves. It is imperative that the rationale for having … See more If the narrow control of material attributes is warranted, this can be achieved by narrow specification on release of raw material through raw material manufacturing … See more Risk assessment and product/process knowledge (QbD or QbD-based approach) provide input in control strategy. An overall process and decision … See more Product and process knowledge along scientific and risk-based approaches drives the development of control strategy. Various controls constitute overall control strategy for product development. Input … See more Guidance from FDA and EMA on process validation stresses the importance of a lifecycle approach toward process validation rather than a onetime approach to demonstrate … See more
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