METHOD DECISION FOR DETERMINING SPECIFIC MICROORGANISMS IN PHARMACEUTICAL PRODUCTS: AN OVERVIEW

Abstract

In the direction of microbiological quality control analysis in pharmaceutical products, determining the microbiological load of the product at the end-use stage is very important for human health. Quality control parameters in pharmaceutical products vary according to the structure of the type of product and administration route. In this context, according to the pharmacopoeias, parenteral products and eye drops are classified as sterile products and the other group of pharmaceuticals are classified as non-sterile products. However, non-sterile pharmaceuticals also must have a certain microbiological quality. For this reason, the pharmaceuticals should have a certain microbiological load and should not contain defined microorganisms specified to its type. Since the control of the microbiological quality of the products is important for safety, it should be determined by quality control analysis. In this study, standard methods used to detect specific microorganism in pharmaceutical products were compared. Application steps in standard methods and identification tests of specific microorganisms were examined. In addition, studies that are alternative to standard methods were evaluated.

                                           

Peer Review History:

Received: 8 August 2020; Revised: 11 September; Accepted: 24 October; Available online: 15 November 2020

Academic Editor: Dr. Muhammad Zahid Iqbal, AIMST University, Malaysia, drmmziqbal@gmail.com

Reviewer(s) detail:

Dr. Mujde Eryilmaz, Ankara University,Turkey, meryilmaz@ankara.edu.tr

Dr. Rawaa Souhil Al-Kayali, Aleppo University, Syria, rawah67@hotmail.com