Strategies for microbiological contamination control in Api (Active Pharmaceutical Ingredients) and finished product Manufacturing: Compliance with USFDA guidelines
DOI:
https://doi.org/10.29070/9nyy5z35Keywords:
Microbial contamination, source of contamination, control of microbial contamination, USFDA concern, USP (United States Pharmacopeia) concern, microbial limit testAbstract
In many cases, the quality of the finished product depends on the microbiological properties of the medicinal components. Manufacturers are expected by the USFDA to quantify and describe the bioburden of their goods. This page describes the USFDA's and compendia's concerns over microbiological contamination. Also covered in this article are ways to identify microbial contamination, how to get rid of it, and where it comes from.
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References
1. Ahmed, Md & Sultana, (2022). Good Manufacturing Practice (GMP) Guideline in Pharmaceutical Industries: Implementation and Its Significance from the view of Pharmacists. International Journal of Modern Pharmaceutical Research, ISSN: 2319-5878, 6(1), 46-60,
2. Ratajczak, Magdalena & Jaworska, Marcelina Maria & Kamińska, D. & Pecyna, Paulina & Dlugaszewska, Jolanta. (2014). Microbiological quality of non – sterile pharmaceutical products. Saudi Pharmaceutical Journal. 47. 10.1016/j.jsps.2014.11.015.
3. Walsh, A., “Microbial Aspects in Cleaning Validation,” in Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices, Madhu Raju Saghee, Tim Sandle, and Edward C. Tidswell, eds., Business Horizons, 2011, ISBN: 978-8-190646-74-1.
4. Gupta, Rajesh. (2014). Validation of Microbiological Methods – Expectations for Regulatory Compliance. Webinar - BioPharma Asia. 3. 24.
5. Roesti, David & Goverde, Marcel. (2019). Microbiological Control Strategy. In book: Pharmaceutical Microbiological Quality Assurance and Control, WILEY, ISBN: 978-1-119-35607-3. (pp.1-21).
6. Halls, N. A. (2002). Microbial control of pharmaceuticals. In J. Swarbrick (Ed.), Encyclopedia of Pharmaceutical Technology (Vol. 1, pp. 1753–1764). Taylor & Francis/CRC Press
7. Fowler, J. (2005). Monitoring your production environment. In Troubleshooting Microbial Contamination in an Industrial Environment (Mould & Bacteria Reviews, Issue 11). Retrieved from https://www.researchgate.net/publication/40999115_Microbial_Contamination_A_Regulatory_Perspective
8. Baird, R. M., Hodges, N. A., & Denyer, S. P. (2000). Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices. CRC Press. ISBN: 978-0203305195.
9. Nighat Razvi, R. A.(2014). Estimation of microbial contamination in various API and Excipients. World journal of Pharmacy and Pharmaceutical sciences,1771-1777.
10. Chatwal, G. R., and M. Arora. Pharmaceutical Chemistry – Inorganic (Vol. I): Impurities and Pharmaceutical Substances and Their Limit Tests. Himalaya Publishing House, 2010, pp. 28–71.
11. Saba Sultana and Shahid Mohammed (2018). A Review on Stability Studies of Pharmaceutical Products. International Journal for Pharmaceutical Research Scholars (IJPRS), ISSN: 2277 – 7873, V-7, I-1, 2018
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