Microbiological Testing of Pharmaceuticals: Legal Requirements

Quality Control in Pharmaceuticals

Pharmaceutical production is not limited to formulation and packaging. In particular, antimicrobial drugs and pharmaceutical products containing preservatives must be rigorously tested to ensure that they are indeed effective against microorganisms. This is where microbiological drug testing comes in to assess how effective the drug is against the targeted microorganisms.

What are Microbiological Drug Tests?

Microbiological drug tests are scientific analyses to measure the antibacterial, antifungal or antiviral activity of a drug against specific microorganisms. These tests determine whether a product is truly therapeutic or whether the preservatives it contains adequately inhibit microbial growth.

Why is Antimicrobial Efficacy Important?

Patient Safety: Drugs with low efficacy may be ineffective in treating the disease. This situation both jeopardizes patient health and paves the way for the development of drug resistance.
Product Stability: It is vital that preservatives prevent microbial growth, especially in products with a long shelf life.
Regulatory Compliance: According to the standards specified in pharmacopoeias, certain products must undergo antimicrobial efficacy testing.

Major Microbiological Activity Tests

Preservative Efficacy Test (PET):Tests the effectiveness of preservative agents, usually found in topical and liquid products, against bacteria, fungi and yeasts. This test is performed by intentionally contaminating the drug with specific microorganisms and observing the change in the number of microorganisms over time.
Minimum Inhibitory Concentration (MIC) Test: Determines the lowest concentration of drug required to stop the growth of a particular microorganism.
Agar Diffusion Method:The drug is applied to an agar surface containing microorganisms. The “growth inhibition ring” that forms around the drug indicates its antimicrobial potency.
Time-Concentration Curve Analyses:Observe how the number of microorganisms changes over time after drug administration.

Clinical and Industrial Importance

These tests are particularly applied to products such as antibiotics, antiseptics, topical creams, eye drops and solutions for injection. On an industrial scale, these tests play a major role in both the licensing of drugs and the process of keeping them on the market.

Nanolab Laboratories Group continues to provide services within the scope of Drug Analysis. You can also consult us about Nitrosamine Analysis.

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