A REVIEW OF PHARMACEUTICAL PROCESS VALIDATION

Registration ID: IJNRD_186217

Published ID: IJNRD2301187

DOI: Click Here to Get

ASHNA ARYAL , Ms. Gulbahar , Mr. Saurabh Pant

Process validation, Protocol, Quality, Quality Management

The most well-known and crucial GMP parameter is validation. According to the U.S. Food and Drug Administration, this article provides an overview of process validation of pharmaceutical manufacturing processes and discusses its significance (FDA). An introduction and general overview of the process validation of the pharmaceutical manufacturing process are included in this study. Quality must be built into the product at every stage and not merely tested for at the end using quality assurance tools. The production of a drug with reproducible quality will be ensured via process validation. Process Validation is used in the pharmaceutical industry to accomplish this task as, in accordance with ISO 9000:2000, it has demonstrated to be a key instrument for quality management of pharmaceuticals. Process validation is typically carried out prior to the release of a new product, if a change is made to an existing product, and on an ongoing basis to ensure the process is working as intended. A protocol should be established at the outset that details the parameters that will be tracked, the samples that will be collected, and the results that will be accepted.

Published Paper   E-Certificate

ASHNA ARYAL, Ms. Gulbahar, & Mr. Saurabh Pant (January-2023). A REVIEW OF PHARMACEUTICAL PROCESS VALIDATION. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 8(1), b720-b729. https://ijnrd.org/papers/IJNRD2301187.pdf

Volume 8 Issue 1, January-2023

Pages : b720-b729

Paper Reg. ID: IJNRD_186217

Published Paper Id: IJNRD2301187

Downloads: 000121988

Research Area: Pharmacy

Country: Dehradun, , Uttarakhand, , India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2301187.pdf

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2301187

Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

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