ICH Method Development and Validation

Tepnel performs analytical method development and validation in accordance with the ICH Q2 (R1) guidance and cGMP for both small and large molecules.

Each regulatory submission must include the appropriate analytical procedures necessary to ensure the identity, strength, quality, purity and potency of the drug substance and drug product, including bioavailability. Tepnel has extensive experience in method development and validation that works to deliver data which establishes that any analytical procedures used in testing meet proper standards of accuracy and reliability and are suitable for their intended purpose.

The principles of methods development and validation apply to all types of procedures, however; pharmaceuticals that are derived from biotechnological/biological processes may have distinguishing characteristics which necessitate more complex analytical methodologies.

Our method development and validation service offers the development and validation of regulatory compliant procedures ranging from conventional HPLC through to complex monoclonal and polyclonal bioassays that can be routinely used to support either stability testing or lot release testing in the discovery, development and manufacture of pharmaceuticals.

Our method development and
validation services include:

We provide analytical chemistry and quality control support for method development and validation in accordance with ICH Q2 (R1) guidance documents and current Good Manufacturing Practices. Although not all of the validation characteristics are applicable for all types of tests, typical minimal validation characteristics at Tepnel include:

  • API and drug product methods
  • Stability indicating methods
  • Conventional HPLC and ELISA-based assays
  • Extensive range of detection technologies; including: UV, PDA, FLU, ELSD, MALS, RI, TUV, PDA, SQD-MS, GC-FID and the Waters H-Class HPLC method development platform
  • Potency and purity methods
  • Specificity
  • Linearity
  • Accuracy
  • Precision (repeatability, intermediate precision, and reproducibility)
  • Range
  • Limit of quantitation
  • Limit of detection
  • Stability of samples in matrix
  • Stability of standard stock solutions

You may also be interested in:

API and Finished Products

Large Molecule Formulations

Potency, Purity,
Stability Indicating