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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Pharmaceutical Validation Documentation Requirements
Pharmaceutical validation is a critical process that ensures that pharmaceutical products meet the desired quality standards and are safe fo...
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Validation of the Autoclave is classified into the following 1.0 OQ – Operational Qualification 2.0 PQ – Performance Qualification The valid...
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K. Dashora, D. Singh, Swarnlata Saraf and S. Saraf *. Institute of Pharmacy, Pt.RavishankarShuklaUniversity, Raipur 492 010. *Author for ...
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2.0 Scope: Final visual inspection is performed manually by human operators. Prior to being qualified as an inspector, each in...
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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