Method development and Method validation

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.

 

 

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