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Abstract

PROCESS VALIDATION OF PANTOPRAZOLE GASTRO-RESISTANT AND DOMPERIDONE PROLONGED-RELEASE CAPSULES IP

Shiba S. Morris*, Ishita Sharma and Deepika

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Abstract

Validating a process is gathering and analyzing data from a method's ability to consistently produce a high-quality medicinal component from the process design stage to production in order to create scientific evidence. The purpose of the validation is to ensure that quality is integrated throughout the system rather than just assessed for at the conclusion. It comprises the collection and evaluation of data, beginning with the process design stage and continuing through production, that establishes scientific confirmation that a method is capable of reliably producing a high-quality pharmacological ingredient. A study demonstrates the efficacy of the pantoprazole gastro-resistant and the delayed release capsule for domperidone. Sifting, dry mixing, granulation, extrusion of wet mass, semi-drying, size reduction/milling, drying, final sifting, reprocessing, capsule filling, inspection, and packing were among the process variables that were observed for the process validation batch at the granulation stage. In accordance with the protocol for approved process validation, the sample was removed at various points. All of the analytical findings were deemed to be satisfactory and to be well within the specification parameters.

Keywords: cGMPValidation of the process, capsule filling, and packing.


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