ICH Q2 (R1) was recommended by the International Conference On Harmonization (ICH), and has been published in the Federal Register, FDA, US, adopted by EC, European Union and MHLW/PMDA, Japan, and implemented by Health Canada, Canada. The purpose of the ICH Q2 (R1) validation guidance is to provide recommendations on how to evaluate various validation characteristics for analytical procedures (identification tests; quantitative tests for impurities’ content; limit tests for the control of impurities; and quantitative tests of the active pharmaceutical ingredients). In addition, the document offers an indication of the data which should be presented in a registration application.
Jordi’s chemists are experienced in applying ICH and FDA guidance when performing analytical method validation and can tailor an approach suitable to your application. Below are the parameters Jordi Labs routinely considered when validating analytical methods to assist its clients in the evaluation of their drug substances and drug products under ICH Q2 (R1) validation:
- Detection Limit
- Quantitation Limit