Abstract

Sunidhi Mahant*, Raveena Devi, Chetna Jhagta, Shivali Singla, Sachin Goyal

ABSTRACT

Introduction: Validation is most important Part of cGMP, which require that manufacturing processes be designed and controlled to assure that in-process materials and the finished product meet predetermined quality requirements and do so consistently and reliably. The validation study provides the accuracy, sensitivity, specificity, and reproducibility of the test methods. Method: Process validation of pantoprazole 40mg tablets is conducted, which included the validation of critical steps of manufacturing such as blending, compression and coating. Result & Conclusion: Validation of Pantoprazole-40 Tablet is subjected to physicochemical studies using parameter such as Thickness, Diameter, Hardness, Weight variation, Content uniformity, Disintegration, Dissolution. For all these parameter, average Values and variation are within the limits at each stage of testing.