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 pre-determined specifications and quality attributes
Monday, July 9, 2007
Tablet compression Validation
The process validation of tablet compression processes is accomplished by testing quality attributes such as content uniformity, dissolution, moisture, and other attributes from stratified sampling conducted throughout the process. Machine operating parameters may vary between lots; example parameters include pre-compressing force, main compressing force, and turret speed. After appropriate set-up of operating parameters, in-process testing or machine control of tablet weight, thickness, and hardness maintains compressing at target attributes by adjusting machine parameters.
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1 comment:
very good material where people r waiting eagerly for this material if it made available i will be happy
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