词条 | Design space verification |
释义 |
Design space verification is a part of process validation as defined by the EMA in conjunction with the FDA. Its purpose is to guarantee end product quality within a range of manufacturing boundaries. The effects of scale up activities should be fully understood by the manufacturer. Most initial design space conclusions are based upon laboratory testing or pilot batches with scale up effects being inferred by experimentation or based on statistical evidence, simulations, or studies.[2] Ongoing design space verification should be dependent upon the results of an assessment of risk involved with scale up activities. More specifically, how scaling up production affects scale-dependent variables. Design space verification is much more focused in scope than overall process validation. Design space verification specifically aims to confirm output quality within a given operating range. This allows for changes in operating level flexibility while guaranteeing production quality, and allows for changes in production quantities without necessitating a reevaluation of the production process.[3] References1. ^{{cite web|title= Design Space Verification | url= http://www.atris-systems.com/225.0.html |publisher=Atris Information Systems|accessdate=17 December 2014}} 2. ^{{cite web|title= Questions and Answers on Design Space Verification|url= http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/11/WC500153784.pdf|publisher=European Medicines Agency|accessdate=17 December 2014}} 3. ^{{cite web|title=Design Space Considerations|url= http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM341156.pdf|publisher=FDA|accessdate=17 December 2014}} External links{{Commons category|HTML}}
3 : Quality management|Formal methods|Pharmaceutical industry |
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