Quality is always an essential factor in relation to any product, and it takes on even greater importance in the case of life-saving products such as pharmaceuticals.
Validation consists of obtaining overall approval for a sequence of activities in order to demonstrate and provide documentary evidence that a specific product can be reliably manufactured via the processes in question (thus, it is closely related to substance quality).
As part of the validation process, our experts check the following:
- Specificity (including stability-indicating verification)
- Precision (repeatability, intermediate precision, reproducibility)
- Limit of detection
- Limit of quantification
- Stability of the solution
Our most common tests and services
All our Tests and Services
A medical device, or a material used in a medical device, that comes into direct contact with patients must be able to perform its intended function without inducing significant rejection.
Mérieux NutriSciences provides a comprehensive range of microbiological services relating to medical devices, to support facility and product monitoring, as well as product development and registration.
In relation to pharmaceutical products and medical devices derived from raw materials of animal origin, for which the raw material may contain viruses that are dangerous to human health...
Mérieux NutriSciences has a proven track record in carrying out studies of extractables and leachables in order to detect very low levels of contaminants from materials in contact with medicinal products and medical devices.
Mérieux NutriSciences offers method development and validation solutions for every analytical challenge, through the availability of several qualified analytical techniques in specialized GMP labs.
Forced degradation is synonymous with stress testing and plays a key role in the development of stability-indicating and analytical methods, establishing operative conditions and the design of formulations.