Jul 30, 2028 - Cosmetics
New document from EMA on avoiding microbial contamination in the manufacture of non-sterile medicinal products
In the manufacture of non-sterile medicinal products, contamination control measures are becoming increasingly important, even though the regulatory requirements for these are less detailed than for sterile products.
However, current guidelines, particularly Annex 1, recommend applying principles such as Quality Risk Management (QRM) and the Contamination Control Strategy (CCS) to critical non-sterile medicinal products as well.
On July 13, the EMA (European Medicines Agency) published a Q&A document that explains key questions regarding the prevention of microbial contamination of non-sterile medicinal products and summarizes the most important background information.
The document primarily provides answers to the question of which organizational and other measures should be taken to prevent microbial contamination of non-sterile medicinal products. These include, among others:
- Identification of microorganisms when growth occurs for deviation assessment
- Monitoring used cleaning products for expiration date and possible contamination
- Use of validated microbiological test methods
- Demonstrating the suitability of water for use
- Control of cleaning and disinfection processes
- Regular hygiene training for staff
- Establishment and implementation of a monitoring program
We support you in all matters related to the microbiology of non-sterile medicinal products. This includes testing finished products, raw materials, and water, as well as comprehensive advice on setting up a monitoring program.
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