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 devices
• Forced 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)
• Accuracy
• Precision (repeatability, intermediate precision, reproducibility)
• Limit of detection
• Limit of quantification
• Linearity
• Range
• Robustness
• Stability of the solution