Analytical Method Validation
The objective of analytical method validation studies is to demonstrate that the test procedure performs according to its intended use and purpose. Essential method quality attributes to be investigated are specifity, accuracy and precision.
The validation process is performed in compliance with current ICH Q2 (R2) quality guidelines. Critical factors are to be determined that may have an impact on its sensitivity, robustness and reproducibility. A validated test characterizes the performance of an analytical method and its limitations and provides confidence in data quality.
Analytical Method Validation in compliance with current ICH Q2 (R2) Quality Guidelines
About analytical methods
Analytical methods are necessary to support GMP compliance of the quality control program (e.g. to support characterization studies, stability studies), to test final products for release (release testing), to support process validation studies, to support formulation studies, or to support the drug development program. Protein characterization uses methods such as gel electrophoresis and chromatographic analysis. Peptide mapping has become a powerful tool for examining primary structure modifications as advances in analytics have been made.
“Regulatory Requirements” (FDA)
The cGMP regulations require that the test methods, which are used for assessing compliance of pharmaceutical articles with established specifications, “…must meet proper standards of accuracy and reliability.”(Source FDA)
FDA 21 CFR Part § 211.165 Testing and release for distribution.
e) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with § 211.194(a)(2).
FDA 21 CFR Part § 211.194(a)(2) Laboratory records.
…”that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested.“
Your Benefits
Providing Expertise
- Monoclonal antibodies
- Recombinant proteins
- Bispecifi antibodies
- Cell-based assays
- Viral-based assays
On-site Services
- Release Testing
- Stability Testing
- In-Process Testing
- Laboratory assistance
Laboratory Technology
- Flow Cytometry
- Molecular Biology Techniques
- Cell Biology Analysis
- Immunoassays
- Cell Culture Techniques
- Cell Line Engineering
Instrumental Analysis
- FACS
- HPLC
- Electrophoresis
- DNA/RNA Analysis
- ELISA
- UV/Vis
We assist your laboratory activities, to support your quality control program, process validation studies or your drug development program.