BASIC ASPECTS OF PHARMACEUTICAL PROCESS VALIDATION OF SOLID DOSAGE FORMS: QUALITY ASSURANCE POINT OF VIEW
Ketaki S. Shinde*, Dr. R. C. Doijad, Dr. J. S. Mulla and Sachin S. Mali
The purpose and interest of this overview on pharmaceutical process validation of immediate release tablets, is to highlight the critical process parameters to be validate during the activity of validation of solid dosage form. It is the most common dosage form for orally administration of drug. The Process validation should confirm that the control strategy is sufficient to support the process design and the quality of the product. This validation review covers the solid dosage form of process validation. The process is developed in such a way that the required parameters are achieved and it ensures that the output of the process will consistently meet the required parameters during routine production, the process is validated. A manufacturer can assure through careful design of the device, processes, process controls and process variable that all manufactured units will meet specifications and have uniform quality. This review provides information on objectives and benefits of process validation, types of process validation, major phases in validation and regulatory aspects. Guidelines and strategy for process validation of solid dosage formvalidation and regulatory aspects. Guidelines and strategy for process validation of solid dosage form are also discussed.
Keywords: Pharmaceutical Process Validation, Process Validation Stages, Validation Acceptance Criteria.
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