For microbiological analysis of pharmaceutical products, medical devices or food supplements it is necessary to have adequate microbiological methods that allow detecting the microorganisms in the presence of the tested product.
The most common methods are those described in the European Pharmacopoeia, however, sometimes the product characteristics make needed to make changes in the method or to develop a most suitable one for that product. In any case, the suitability of the method for detecting the microorganisms in the presence of the tested product must be demonstrated because the product itself may impact the microbial growing.
What is needed for these studies?
Qualified microbiological incubators and bacterial strains conservation according to the European Pharmacopoeia are necessary for developing and validating microbiological methods. Additionally, the GMP certification is also needed.
What Netpharmalab offers to you…
At Netpharmalab we have an extensive experience to carry out verifications of European Pharmacopoeia microbiological methods as well as the development and validation of new methods adapted to the product characteristics and to the client’s requirements.