CQA, A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range or distribution to ensure the desired product quality., CPP, A process parameter whose variability has an impact on a CQA and therefore should be monitored or controlled to ensure the process produces the desired quality., CMA, Common pharmaceutical/QbD term for a material attribute whose variability can affect process performance and/or product CQAs and therefore requires an appropriate control strategy., PV, Lifecycle evidence that the manufacturing process can consistently deliver product meeting its predetermined quality requirements. FDA organizes PV into Stage 1 Process Design, Stage 2 Process Qualification, and Stage 3 Continued Process Verification., SU, The unit/site from which the product, process, analytical knowledge and associated technology are transferred. WHO establishes SU as the abbreviation for sending unit., RU, The unit/site receiving the transferred product/process/knowledge and demonstrating its ability to implement the transferred technology appropriately. WHO establishes RU as the abbreviation for receiving unit., Technology Transfer, The lifecycle stage in which product and process knowledge is transferred between development and manufacturing, and within or between manufacturing sites, to achieve product realisation.

Basic Terms

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