GMP Services for the Pharmaceutical Industry

Analytical Method Validation

The objective of the 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 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.

Bioanalytical method validation conducted under by a lab technician in a laminar flow.

Analytical Method Validation in compliance with current ICH Q2 Quality Guidelines

Laboratory analysis conducted by a scientist.

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 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
Image shows a gene therapy illustration. A defective DNA element (Gene) is cut out and corrected through insertion of a corrected gene using recombinant DNA techniques. The Goal is to treating or preventing genetic hereditary diseases by altering a person's genome. Gene Therapy illustration showing DNA damages and insertion of on scientific background.
Bioanalytical analysis performed in a 96 well plate.

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
Protein separation on gels in a Electrophoresis chambers. Electrophoresis method for proteinanalytic.
DNA amplification, Reverse transcription PCR, RNA, scientist performing PCR analysis for method validation.

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.