We are familiar with working with teams carrying out method validation work to meet regulatory requirements, and for internal cGMP needs.
Method validation is the confirmation by examination and provision of objective evidence that the requirements for a specific intended use or application have been fulfilled. Validation is a process; usually starting with an in-house single validation exercise which can then progress to validation at multiple sites and then to standardised publication.
We are happy to produce our own Validation Protocols, or work to those formats provided by the client (the client always agrees and signs the protocol).
After execution of the protocol results are provided as a final method validation report in line with the protocol, with the method details included or referenced. Typical test method validation parameters are based on ICH guidelines (e.g. robustness, linearity, limit of detection, limit of quantitation, accuracy, precision, and specificity), or as otherwise agreed with the client.
Agenda1 has significant experience in the validation of the following types of methods:
- HPLC (assay and impurities methods, cleaning verification methods)
- Liquid injection Gas Chromatography (solvent identification and release test methods)
- Headspace Gas Chromatography (residual solvent analysis)
- Physical methods such as Malvern and Sympatec particle sizing, Specific Surface Area by BET and XRPD
- Trace and major elemental determination by ICP-OES and X-Ray Fluorescence and Total Organic Carbon analysis
- API raw material and chemical intermediate methods (Karl Fischer, Titration, Loss on Drying, Residue on Evaporation etc)