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Abstract
The development of a drug product is a lengthy process that involves drug discovery, laboratory testing, animal studies, clinical trials, and regulatory registration. Many regulatory agencies, such as the FDA, require that the drug product be tested for its identity, strength, quality, purity, and stability before it can be released for use. To check the final quality of a product, a series of quality control tests have been devised. Quality control tests are tools to ensure, not guarantee, the quality of a product. Validation and quality assurance go hand in hand, ensuring thorough quality for pharmaceutical products.
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References
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- Jatto E, Okhamafe AO. An Overview of Pharmaceutical Validation and Process Controls in Drug Development. Tropical Journal of Pharmaceutical Research. 2002; 1(2):115-22.
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- Sharma H, Sapkota HP, Dangi NB. A Brief Review of Analytical Methods for the Estimation of Allopurinol in Pharmaceutical Formulation and Biological Matrices. International Journal of Analytical Chemistry. 2021 Jun 5; 2021.
- Rodrigues CD. Optimization of 3D porous structures for controlled drug delivery using quality by design method (Doctoral dissertation).
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References
بابک، گ، بدری، و. بررسی اهمیت اعتباردهی شستشوی ماشین‌های تولید ادویه، مجله‌ی علمی پوهنحی فارمسی پوهنتون کابل( درمل)، مطبعه‌ی نوری، (۱۳۹۵) صص: ۱۰- ۱۶
Jatto E, Okhamafe AO. An Overview of Pharmaceutical Validation and Process Controls in Drug Development. Tropical Journal of Pharmaceutical Research. 2002; 1(2):115-22.
Validation P. General Principles and Practices. Guidance for Industry (Jan. 2011). 2011 Jan.
Jamil F, Kumar S, Sharma S, Vishvakarma PS, Singh L. Review on stomach specific drug delivery systems: development and evaluation. Int J Res Pharm Biomed Sci. 2011 Dec; 2(4):14271433.
Bhanderi M, Shah J, Gorain B, Nair AB, Jacob S, Asdaq SM, Fattepur S, Alamri AS, Alsanie WF, Alhomrani M, Nagaraja S. Optimized Rivastigmine Nanoparticles Coated with Eudragit for Intranasal Application to Brain Delivery: Evaluation and Nasal Ciliotoxicity Studies. Materials. 2021 Jan; 14(21):6291.
McPolin O. Validation of analytical methods for pharmaceutical analysis. Lulu. Com; 2009 May 1.
Nandhakumar L, Dharmamoorthy G, Rameshkumar S, Chandrasekaran S. An overview of pharmaceutical validation: Quality assurance view point. IJRPC. 2011;1(4):1003-14.
Sharma H, Sapkota HP, Dangi NB. A Brief Review of Analytical Methods for the Estimation of Allopurinol in Pharmaceutical Formulation and Biological Matrices. International Journal of Analytical Chemistry. 2021 Jun 5; 2021.
Rodrigues CD. Optimization of 3D porous structures for controlled drug delivery using quality by design method (Doctoral dissertation).
Aleem H, Zhao Y, Lord S, McCarthy T, Sharratt P. Pharmaceutical process validation: an overview. Proceedings of the Institution of Mechanical Engineers, Part E: Journal of Process Mechanical Engineering. 2003 May 1; 217(2):141-51.
WHO Guidelines on Validation. (2016): 5- 21