Analytical development:
A sustainable method development for a better analytical method life cycle management
Validation:
Protocol adapted to the intended use, as defined in the ICH Q2 (R1) Guidelines, study design adapted to statistical interpretation and anticipation of the analytical method life cycle
Transfer:
Transfer design compliant with USP <1224> and according to the risk analysis performed for each analytical method.
Communication of the method to the site before validation for better familiarization. Evaluation of method changes and additional validation performed if needed.
Protocol discussed and approved with you to include all your requirements
Descriptive statistics (mean, SD, RSD, confidence interval, linear regression)
Total error approach with tolerance interval (SFSTP works referenced in USP <1210>)
Prediction interval approach defined in USP <1210>
In-depth review of validation data shared with you:
Robustness study of the method before validation of the method
Highlight the strengths and weaknesses of the method (if applicable)
System suitability test (SST) adapted to each method in order to keep the method under control
Limitation to documentary transfer
Familiarization with a simple method
Collaborative test or (partial) revalidation for critical tests
Definition of acceptance criteria, in line with product specifications and method performance
Technical support to ensure a successful implementation on your site or your CDMO site:
Develop methods with the aim of using them routinely in a quality control laboratory
Evaluate the robustness of the methods and define the critical parameters of the method from the development stage with the AQbD methodology (ICHQ14)
Pre-validate to refine knowledge of the validation method and acceptance criteria Write a full analytical procedure to avoid any risk of error or omission for future users
Ensure the management and sharing of knowledge acquired in development and support our customers in defining a control monitoring strategy (SST, control charts)
CEBIPHAR frequently adapts its organization to ensure the shortest possible timelines to start a new project or to manage project change of scope
