METHOD VALIDATION

Method validation in compliance with current ICH Q2 and ICH Q14 quality guidelines

Use of analytical procedures

Analytical procedures are necessary to support 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 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

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.”

Example of FDA's regulations

§ 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).

§ 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.

Our Method Validation Services

The objective of the validation studies is to demonstrate that the test procedure performs according for 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 and ICH Q14 quality guidelines. Critical factors are to be determined that may have an impact on its sensitivity, robustness and reproducibility.

A validated test procedures characterizes the performance of an analytical method and their constraints.

Our Expertise

We provide sound knowledge and 20+ years hands-on experience with analytical procedures and method validation. Our engineers will assist your laboratory activities, to support your quality control program, process validation studies or your drug development program.

Our Services

  • Supporting UV-Vis, PCR, qPCR, HPLC, Sequencing, ELISA, Dot Blot, endotoxin and residual testing
  • In-process control testing
  • Release and stability testing of samples
  • Statistical analysis of data
  • Technical transfer of test methods
  • Supporting general QC operations,
  • Supporting scientific and laboratory assistance

Your Benefits:

  • Contributing to validated test methods
  • Contributing to quality control operations
  • Contributing to GMP release of samples