Development & validation are time-consuming and a diversion of valuable resource. Some customers have the expertise to develop and validate test methods in-house but this would mean diverting headcount away from valuable QC testing. Other customers lack internal expertise to develop, validate or improve test methods.
Validation of an analytical procedure is performed in order to demonstrate that the procedure is suitable for its intended use. Validation is performed in order to show that the result(s) generated by a particular analytical procedure are reliable and accurate.
The principles and practices of validation of analytical procedures are covered by the International Conference on Harmonisation (ICH), are published as guideline Q2(R1), “Validation of Analytical Procedures: Text and Methodology” and are available from https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf. A full discussion of the terms and methodology applicable to validation of analytical procedures are provided in ICH documents.
We can provide a full development service including protocol development, validation in accordance with ICH guidelines or in-house requirements and Analytical Method Transfer (AMT)
- Related Substances & Impurities
- Potency / Assay
- Cleaning Validation