Validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes
Monday, July 9, 2007
Tablet Coating Validation
The process validation of tablet coating processes is accomplished by testing quality attributes such as tablet weight, dissolution, physical appearance, and other attributes from coating runs. Machine operating parameters may vary between lots; most variation is observed in individual coating run batch size. Coating batch size depends on the yield of compressed tablets. The coating batch size may significantly influence coating performance in perforated pan coaters in which air flow through the tablet bed is an important operating parameter.
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