Method Development, Validation and Transfer

We have a comprehensive knowledge in the development and validation of analytical proprietary and non-proprietary methods for excipients, APIs, intermediate products and finished products, according to the ICH Q2 (R1) in line with Q6A and Q6B. Our methods are ready for transfer to contract-giver, in compliance with EU-GMP chapter 6, performing a comparative test, a co-validation in two sites or a revalidation.

Analytical methods available:

• Identification
• Assay testing
• Related Substances
• Residual Solvents
• Elemental impurities
• Genotoxic impurities
• Dissolution
• Stability indicating methods
• Leachables and extractables
• Cleaning and process validation

The parameters to be included in the method validation are the following:

• Accuracy
• Precision (repeatability, intermediate precision, reproducibility)
• Specificity
• Detection limit
• Quantitation limit
• Linearity
• Range
• Robustness
• System suitability test