Paper Title
Process Validation of Pantoprazole
Article Identifiers
Authors
Keywords
consistency, documentation, GMP ,process verification, , specification,
Abstract
The USFDA defines process verification as the production of documented evidence that provides a high level of assurance that a particular process consistently produces products that meet prescribed specifications and quality attributes. †was defined. Verification confirms that the process equipment can operate within the required parameters. Verification itself not only improves the process, but also confirms that the process is well designed and controlled. According to Indian Pharmacopoeia, pharmaceutical tablets are solid, flattened or biconvex shells and are unit dosage forms made by compressing a drug or mixture of drugs with or without diluents. Validation studies should provide, establish and document the accuracy, sensitivity, specificity and reproducibility of the test methods used by the company. Validation is therefore an integral part of quality assurance.
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How To Cite (APA)
Kajol Verma, Ms. Gulbahar, & Mr. Saurabh Pant (January-2023). Process Validation of Pantoprazole. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 8(1), a897-a902. https://ijnrd.org/papers/IJNRD2301100.pdf
Issue
Volume 8 Issue 1, January-2023
Pages : a897-a902
Other Publication Details
Paper Reg. ID: IJNRD_185892
Published Paper Id: IJNRD2301100
Downloads: 000122253
Research Area: Pharmacy
Author Type: Indian Author
Country: Dehradun, uttarakhand, India
Published Paper PDF: https://ijnrd.org/papers/IJNRD2301100.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2301100
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