Process Validation of Metformin Hydrochloride Tablet (500 mg) according to USFDA

Abstract

Metformin hydrochloride is an oral anti-diabetic drug from the biguanide class used mainly to treat type 2 diabetes mellitus. As per ISO 17025, Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for specific intended use are fulfilled. This research aimed to study prospective process validation for Metformin Hydrochloride 500 mg tablet dosage formulation. One initial process validation with a batch size of 200 tablets was performed. Furthermore, method, equipment, and validation criteria were taken. The critical parameter involved in sifting, blending, and compression stages were identified and evaluated as per the validation master plan. The outcome indicated that this process validation data provides a high degree of assurance that the manufacturing process produces products meeting its predetermined specifications and quality attributes.

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