INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016
Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI)
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.
Keywords:
Process validation, Protocol, Quality, Quality Management
Cite Article:
"A REVIEW OF PHARMACEUTICAL PROCESS VALIDATION", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 1, page no.b720-b729, January-2023, Available :http://www.ijnrd.org/papers/IJNRD2301187.pdf
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ISSN:
2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
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