Evaluation of Non-Sterile Products in Pharmaceutical Industry in Terms of Microbial Load for Quality Control Purposes

Abstract

According to the Good Manufacturing Practices (GMP) guideline, it is mandatory to test for compliance in terms of quality control of every material that are either contained in, or has direct contact with the products manufactured and used in Pharmaceutical Industry. Especially, the materials must be tested microbiologically by using multiple methods according to the guidelines of European Pharmacopeia (EP). For this purpose, it is aimed to determine the compliance of the chosen test and the validation methods related to the structure of the product and their microbiological limits.