Follow
International Journal of Current Microbiology and Applied Sciences (IJCMAS)
IJCMAS is now DOI (CrossRef) registered Research Journal. The DOIs are assigned to all published IJCMAS Articles.
Index Copernicus ICI Journals Master List 2023 - IJCMAS--ICV 2023: 95.56 For more details click here
National Academy of Agricultural Sciences (NAAS) : NAAS Score: *5.38 (2020) [Effective from January 1, 2020] For more details click here

Login as a Reviewer


See Guidelines to Authors
Current Issues
Download Publication Certificate

Original Research Articles                      Volume : 14, Issue:5, May, 2025

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

Int.J.Curr.Microbiol.App.Sci.2025.14(5): 78-96
DOI: https://doi.org/10.20546/ijcmas.2025.1405.009


A Comprehensive Review on Microbiological Testing in the Pharmaceutical, Nutraceutical and Cosmetics Industries: Safety Assurance and Regulatory Standards
ITTS Labs, 2500 Nesconset Hwy, Bldg 19, Unit 72C, Stony Brook NY, 11790
*Corresponding author
Abstract:

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.


Keywords: Microbiological Testing, Pharmaceutical, Nutraceutical & Cosmetics Industry


References:

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

Download this article as Download

How to cite this article:

Sricharan Gumudavelli, G. Srinija and Chinna Reddy Palem. 2025. A Comprehensive Review on Microbiological Testing in the Pharmaceutical, Nutraceutical and Cosmetics Industries: Safety Assurance and Regulatory StandardsInt.J.Curr.Microbiol.App.Sci. 14(5): 78-96. doi: https://doi.org/10.20546/ijcmas.2025.1405.009
Copyright: This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike license.

Citations