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Abstract

PROCESS VALIDATION OF ORAL SOLID DOSAGE FORM: TABLET – AN OVERVIEW

Mohammad Zameeruddin, Kale Shweta S.*, Jadhav Suryakant B., Kadam Vaishali S., Chaware Swapna S.

ABSTRACT

Establishing documented evidence which provides a high degree of assurance that a specific process for manufacturing of tablets will consistently produce a product meeting its pre-determined specifications and quality attributes. It mainly involves the steps to be followed to evaluate and qualify the acceptability of the manufacturing process of Tablets. The process is limited to the three batches manufactured of specific batch size with specified equipments and control parameters for Tablets. The results suggest providing documentary evidence that all the manufactured Tablets were evaluated as per specifications. The steps involved such as Blend uniformity results between 90% - 110%, compression assay results between 95%-105% were found within acceptable limits. Other tests related to compression such as hardness, thickness, disintegration, dissolution and for coatings such as weight gain, dissolution were found within acceptable limit.

Keywords: Solid dosage form; Validation; Process validation; Tablet.


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