Quantitative determination and absence of microorganisms

The quantitative determination of the microbiological load and testing for the absence of specific microorganisms are important components in the quality assurance of non-sterile products. Compliance with applicable standards and the implementation of efficient quality controls are essential to ensure consumer safety and protect the company’s reputation.

The regulations for checking the microbiological quality of pharmaceutical products and raw materials have been harmonized between the European (Ph. Eur.), US-American (USP) and Japanese Pharmacopoeias (JP), see paragraph “Guidelines”.

The microbial testing of non-sterile products is carried out according to the procedures described in the general chapters: “Microbial Enumeration Tests” and “Tests for Specified Microorganisms”

Acceptance criteria for the microbiological quality of non-sterile dosage forms are defined in specific chapters: “Acceptance criteria for microbiological quality of non-sterile dosage forms”.

A test with validation (= method suitability test) must be carried out once for each product type / product formulation, i.e. the validity of the quantitative determination of the microorganisms and the validity of the detection method for certain microorganisms must be demonstrated once. A new inspection is only necessary if there are changes to the product or the recipe.

If the product to be tested has antimicrobial activity, this must be removed or neutralized as far as possible.

We will be happy to assist you with your questions on the quantitative determination and absence of microorganisms at
freigabe@gfps.de
.