To date, ALS Scandinavia has performed more than 100 client specific method validations for the pharmaceutical industry. Our instrument park includes 12 ICP-SFMS instruments of which one completely dedicated to services for the pharmaceutical industry. We offer our clients rapid and cost effective method developments and validations according to:
- US Pharmacopeia (USP)
- European Pharmacopeia (Ph.Eur.)
- ICH Guidelines
The method validation process
All the steps included in a method validation are performed in close collaboration with our customers, typically as follows:
- The analytical method is either proposed by our customer or developed by ALS Scandinavia.
- A validation plan is elaborated by ALS Scandinavia. This includes all the steps for ensuring compliance with the requested pharmacopoeia/guideline, e.g. specificity, detection- and quantification limits, accuracy, range, precision and linearity. This is reviewed and approved by the customer before any tests are initiated.
- The method validation is then performed as agreed upon between ALS Scandinavia and the customer.
- Finally, the validation report is prepared and sent to the customer for review and approval.
For more information, please contact us.