service  Développement Validation Transfert Cebiphar

Development Validation Transfer

Analytical development:
A sustainable method development for a better analytical method life cycle management

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 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.

Customized support

CEBIPHAR can fit your needs

  • Clear definition of the intended use of the method, the profile of future users and the expected performance (ATP = Analytical Target Profile)
  • Development strategy offering methods suitable for routine use in a quality control laboratory
  • Forced degradation studies on API, placebo and finished product
  • Application of the AqbD approach according to your target analytical profile
  • Assessment of the robustness and critical parameters of the method
  • In-depth review of method performance (USP <1210>, total error approach, method capability) in order to ensure the reliability of the data generated (method full understanding)

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:

  • Method capability
  • Analytical risk assessment (risk of false positive OOS)

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:

  • Direct contact with the receiving site
  • Pictures and movies
  • Assistance on manufacturing site
Business process

Discover the 4 phases of the life cycle of the analytical method

Interactions process

Our approach



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


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