Aug 5, 2026 - Cosmetics
Testing the microbiological quality of non-sterile pharmaceutical products – Ph. Eur.
The microbiological quality of non-sterile medicinal products is an essential component of pharmaceutical quality assurance. It is regulated by the Medicines Act (AMG), EU GMP guidelines, and the European Pharmacopoeia (Ph. Eur.).
The latter sets out microbiological limits and testing procedures for non-sterile medicinal products, particularly in chapters 2.6.12, 2.6.13, and 5.1.4.
Regular microbiological testing and risk-based monitoring of raw materials, water, production environment, manufacturing processes, and end products ensure compliance with these requirements. In case of microbial growth, identification of the isolated microorganisms is necessary.
The investigation results feed into a Root Cause Analysis and form the basis for appropriate Corrective and Preventive Actions (CAPA).
Although EU GMP Annex 1 primarily relates to the manufacture of sterile medicinal products, its core principles—especially the Contamination Control Strategy (CCS), risk-based microbiological monitoring, trend analysis, and systematic identification of microorganisms—are also of great importance for the manufacture of non-sterile medicinal products and are applied there as well.
We conduct microbiological testing of end products and raw materials for you. If necessary, we conduct a suitability test in advance to demonstrate the method's suitability. We are also your quick and reliable partner for the evaluation of monitoring samples and microorganism identification.
A phone call is enough! We look forward to hearing from you!
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