In drug development, pharmaceutical analysis primarily focuses on methods for identifying and quantifying potential new drug candidates, determining purity, identifying by-products and degradation products in compatibility and stability studies, and determining the drug substance's fate in the organism. Pharmaceutical manufacturing relies heavily on quality assurance. It guarantees the quality of the items produced at the production plant. Although it is commonly assumed that documentation is the primary role of quality assurance, it also regulates the manufacturing system in order to produce a high-quality product. Quality assurance (QA) is critical in the pharmaceutical sector for ensuring that pharmaceutical products are prepared to a safe and uniform standard. QA is a broad term that refers to anything that can affect the quality of a drug during its research, development, manufacturing, and distribution phases.
- Quality control and quality assurance
- Pharmaceutical quality control
- Scope of Pharmaceutical Analysis and Quality Assurance
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Title : Engineered nanomaterial-mediated systemically administered m-RNA-based gene therapy directed exclusively to cancer, present successes and future prospects
A C Matin, Stanford University, United States