![]() |
PRINT ISSN : 2319-7692
Online ISSN : 2319-7706 Issues : 12 per year Publisher : Excellent Publishers Email : editorijcmas@gmail.com / submit@ijcmas.com Editor-in-chief: Dr.M.Prakash Index Copernicus ICV 2018: 95.39 NAAS RATING 2020: 5.38 |
Microbiological testing is a critical component of quality assurance in the pharmaceutical, nutraceutical, and cosmetic industries, where microbial contamination can compromise product safety and pose significant health risks, particularly to immunocompromised or vulnerable populations. This review systematically examines key microbiological assays, including sterility testing, bacterial endotoxin assessment, microbial limit testing, and preservative efficacy evaluation. This review further analyzes the regulatory landscape governing these practices, with particular emphasis on standards established by the United States Pharmacopeia (USP), U.S. Food and Drug Administration (FDA), and internationally harmonized guidelines. The integration of robust microbiological quality control measures and adherence to regulatory standards are underscored as essential to ensuring product integrity and protecting public health.
Antonella G, Laura M, Salvatore De B, Irene Conforti, Luigi P, Marco G, Giovanni L, Francesco A. Microbiological Stability of Cosmetics by using Challenge Test Procedure. Journal of pure and applied microbiology. (2018); 12(1) :23-28. https://doi.org/10.22207/JPAM.12.1.04
Baba-Moussa F, Adjanohoun A, Anihouvi VB, Ahouandjnou H, Sanni S, Omansen TF, Kotchoni SO. Quality-Based Microbial Contamination Analysis of Nutraceuticals. International Research Journal of Biological Sciences (2013); 2(1): 46-5.
Chinna Reddy P, Dudhipala NR, Battu SK, Goda S, Repka MA, Yamsani MR. Combined dosage form of pioglitazone and felodipine as mucoadhesive pellets via hot melt extrusion for improved buccal delivery with application of quality by design approach. Journal of Drug Delivery Science and Technology. 2015; 30(9): 209-219. http://dx.doi.org/10.1016/j.jddst.2015.10.017
Cristianne CCL, Franciele S, Gabriela N, Eduardo BL, Marivane L. Microbiological contamination in cosmetics. International Journal of Development Research. (2022); 12(9):58891-58894. https://doi.org/10.37118/ijdr.25348.09.2022
Fatimah MA. Microbiological Quality Assessment of Skin and Body Care Cosmetics by using Challenge test. Saudi Journal of Biological Sciences. (2024); 31(4): 103965. https://doi.org/10.1016/j.sjbs.2024.103965.
Gurajala S. Artificial intelligence (AI) and medical microbiology: A narrative review. Indian Journal of Microbiology Research. (2024); 11(3):156-162. https://doi.org/10.18231/j.ijmr.2024.029
Mahboob N, Aliasghar H, Solmaz MD, Vahid J, Farzaneh L. An Overview on Novel Microbial Determination Methods in Pharmaceutical and Food Quality Control. Adv Pharm Bull. (2016); 6(3):301-308. https://doi.org/10.15171/apb.2016.042
Mane SR, Bais SK, Dongre VB. Review Article on Microbiology. international Journal of Advanced Research in Science, Communication and Technology (IJARSCT). (2023); 3(2). http://dx.doi.org/10.48175/IJARSCT-8294
Mukati A, Prasad A, Indrani B, Anjali T, Dhwani U. Microbial Limit Test [MLT] of Pharmaceutical Product: A Review. Bulletin of Environment, Pharmacology and Life Sciences. Bull. Env. Pharmacol. Life Sci. (2022); (2):287-293.
Palem CR, Battu SK, Gannu R, Yamsani VV, Repka MA, Yamsani MR. Role of cyclodextrin complexation in felodipine-sustained release matrix tablets intended for oral transmucosal delivery: Invitro and exvivo characterization. Pharmaceutical Development and Technology. 2012; 17(3): 321–32. https://doi.org/10.3109/10837450.2010.535829
Palem CR, Gannu R, Yamsani SK, Yamsani VV, Yamsani MR. Development of bioadhesive buccal tablets for felodipine and pioglitazone in combined dosage form: In vitro, ex vivo, and in vivo characterization. Drug Delivery. 2011; 18(5): 344–52. https://doi.org/10.3109/10717544.2011.557786
Rehan H, Asghar M, Anjum Z, Geetha Kumari D, Zameer A. Introduction to Pharmaceutical Microbiology. Journal of Dermatology and Dermatitis. (2024); 9(7): http://dx.doi.org/10.31579/2578-8949/172
Sanchita C, Suchitra G. Methods for evaluation of microbiological safety, guidelines governing the quality and survey on microbial contamination of commercial cosmetic products -a review. World Journal of pharmaceutical and medical research. (2017); 3(8):85-94
Shikha G, Deepti P, Amit G, Viney L. Safety, Quality and Regulatory Aspects of Nutraceuticals. Applied Clinical Research, Clinical Trials and Regulatory Affairs (2017); 4(1):36-42. http://dx.doi.org/10.2174/2213476X03666160801150607
United States Pharmacopeia (USP). General Chapter ; and General Chapters on Microbial Testing (2023).
Veronika W, Rapid Bacterial Endotoxin Testing (BET). American Pharmaceutical review. (2016)
Zahraa AH, Vildan C. Pharmaceutical products microbial contamination: approaches of detection and avoidance. Microbes and Infectious Diseases. (2025); 6(1): 159-170. https://doi.org/10.21608/mid.2024.266636.1785![]() |
![]() |
![]() |
![]() |
![]() |