Sep 1, 2026 - Cosmetics
European Pharmacopoeia (Ph. Eur.) - Planned revision of the microbiological requirements for non-sterile medicinal products
The microbiological quality of non-sterile medicinal products
is an essential component of pharmaceutical quality assurance.
Key requirements and test procedures are set out in Chapters 2.6.12, 2.6.13
and 5.1.4 of the European Pharmacopoeia (Ph. Eur.).
The European Directorate for the Quality of Medicines & HealthCare (EDQM) published on 1 July 2026 in Pharmeuropa
38.3 drafts for the revision of the following chapters:
- 2.6.12 – Microbial enumeration tests
- 2.6.13 – Tests for specified microorganisms
- 5.1.4 – Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use
Important: Until 30 September 2026 stakeholders can comment
on the drafts regarding central test and quality specifications – currently
there is no immediate need for action. We are following the further
development of the Ph. Eur. chapters and will keep you informed of any
possible upcoming changes.
Regardless of the ongoing revision, regular microbiological testing of starting materials and
finished products, as well as risk-based monitoring of water,
the production environment and manufacturing processes, remain important elements of quality assurance.
In the event of microbial growth, identification of the isolated
microorganisms is also required.
In our laboratory we perform – if required – in advance a product-specific suitability test to demonstrate the suitability of a
test method. We are also your rapid and reliable partner for the evaluation of monitoring samples
and for organism identification.
Do you have any questions? We look forward to hearing from you!
Source:
EDQM: Pharmeuropa 38.3 published