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).
Thanks to our highly qualified experts and state-of-the-art instruments, Mérieux NutriSciences is able to offer services such as:
- Method development and validation for pharmaceutical products and medical devicesForced degradation studies
- Identification of unknown impurities
- Identification of foreign particles
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