Prachi Rajesh Patil,
Shweta Vinod Raul,
Sunila A Patil,
- Student, Department of Pharmaceutical Quality Assurance, P.S.G.V.P Mandal’s College of Pharmacy, Untavad, Maharashtra, India
- Student, Department of Pharmaceutical Quality Assurance, P.S.G.V.P Mandal’s College of Pharmacy, Untavad, Maharashtra, India
- Assistant Professor, Department of Pharmaceutical Quality Assurance, P.S.G.V.P Mandal’s College of Pharmacy, Untavad, Maharashtra, India
Abstract
This brief overview outlines the global techniques for figuring out the prevalence of geotaxis impurities (residual solvents and various inorganic and organic impurities) in medications. It is now necessary to reveal a pharmaceutical product’s purity and impurity profiles due to both national and international regulations. These elements are discussed, together with the kinds of impurities, their origins, their control, and regulatory issues, as well as the significance of pharmaceutical quality, efficacy, and safety. The availability of high-quality important pharmaceuticals is a must for the supply of any country’s healthcare system, as inferior medications have the potential to injure or even kill consumers. A medication’s safety and efficacy may be impacted by the presence of unwanted chemicals, even in very small concentrations. Unlike products in other industries, pharmaceuticals are dynamic, and both during production and after final consumption, their color, consistency, weight, and even chemical identity can change. As a result, pharmaceutical quality has long been a global concern and is currently gaining significant attention from regulatory bodies. Pharmaceutical product impurities are a major concern because of the potential harm they may do to medicine stability and shelf life in addition to the intrinsic toxicity of some contaminants. In pharmaceutical and drug products, impurities are harmful chemicals (natural, inorganic, and residual solvents) that can be introduced or created during formulation, aging, or retention with the active pharmaceutical ingredients (APIs). The most prevalent impurities in all APIs are organic ones, which, even with appropriate handling, are naturally incorporated during the multi-step synthesis process.
Keywords: Practical consideration in developing QA/QC system, Element of QA & QC, Inventory Agency, QA/QC Plans, QA procedure, Q. Assurance, Review process, Methodology.
[This article belongs to Research & Reviews: A Journal of Drug Formulation, Development and Production ]
Prachi Rajesh Patil, Shweta Vinod Raul, Sunila A Patil. Quality Control and Assurance Practices in Modern Pharmaceutical Industry. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2025; 12(03):07-13.
Prachi Rajesh Patil, Shweta Vinod Raul, Sunila A Patil. Quality Control and Assurance Practices in Modern Pharmaceutical Industry. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2025; 12(03):07-13. Available from: https://journals.stmjournals.com/rrjodfdp/article=2025/view=225991
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| Volume | 12 |
| Issue | 03 |
| Received | 27/06/2025 |
| Accepted | 31/07/2025 |
| Published | 09/09/2025 |
| Publication Time | 74 Days |
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