Paper Title
Quality Control and Quality Assurance in Pharmaceuticals
Article Identifiers
Authors
Pritee Rajendra Supe , Prajakta Nilkanth Patane , Dr.Mrs.Rupali R.Bendgude.
Keywords
Quality Control, Quality Assurance
Abstract
A component of quality management, quality assurance is the process of giving assurance that the requirements for quality will be met. One way to characterize quality control is as a component of quality management that is concerned with meeting quality standards. Quality assurance (QA), quality control (QC), and good manufacturing practice (GMP) are critical considerations in the production, distribution, and marketing of pharmaceutical products. These processes ensure the products' identity, potency, purity, pharmacological safety, efficacy, and effectiveness. The phrases quality assurance, quality control, and good manufacturing practices are defined in most international regulatory regulations, including those from the USFDA, WHO, MHRA, TGA, and others. As low-quality medications can cause harm or even death to patients, it has been determined that having an adequate supply of vital medicines is essential to any nation's ability to provide a health care system. Even trace amounts of undesirable substances can affect a medication's safety and effectiveness. In addition to the inherent toxicity of some contaminants, impurities in pharmaceutical products can have detrimental effects on the stability and shelf-life of drugs, which gives rise to significant Concerns. Impurities are undesirable substances (organic, inorganic, and residual Solvents) that are added to or emerge during the manufacture of pharmaceutical and drug Products, or that persists with the active pharmaceutical ingredients (APIs) after they have aged. The most prevalent contaminants in all APIs are organic ones, which, even with appropriate handling, naturally integrate during the multi-step synthesis process. For project managers, quality assurance (QA) and internal control (QC) are becoming more and more crucial. Large expenses could arise from construction site malfunctions or defects. Large expenses could arise from construction site malfunctions or defects. Reconstruction is also necessary and facility operations are hampered, even with little flaws. The end effect is more expenses and longer delays. Internal control and quality assurance are crucial components of any building process that raise the project's standard and consistency. Due to recent significant changes and technological advancements, the need for QA and QC in building projects has expanded significantly technological breakthroughs and high user expectations.
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"Quality Control and Quality Assurance in Pharmaceuticals", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.9, Issue 2, page no.c507-c512, February-2024, Available :https://ijnrd.org/papers/IJNRD2402257.pdf
Issue
Volume 9 Issue 2, February-2024
Pages : c507-c512
Other Publication Details
Paper Reg. ID: IJNRD_214161
Published Paper Id: IJNRD2402257
Downloads: 000121251
Research Area: Pharmacy
Country: A/P-sade, Tal-Karmala, Dist-Solapur, Maharashtra, India
Published Paper PDF: https://ijnrd.org/papers/IJNRD2402257.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2402257
About Publisher
Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)
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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This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition


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