As large pharmaceutical companies outsource both ancillary services like analytical work, and even the full scale manufacture to specialist companies, we find ourselves working with both types of companies.
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Method verification is used to demonstrate that a standardised published method (e.g. Pharmacopoeial method) can be run effectively in a given laboratory.
Method verification is the confirmation by examination and provision of objective evidence that a fully validated standardised published method (i.e. one that has undergone reproducibility validation such as a Pharmacopoeial method) has been satisfactorily established under conditions of actual use at a given laboratory facility.
The requirements for method verification are therefore less stringent than for validation but the principle approach is the same; a formal Verification Protocol with defined acceptance criteria is produced and agreed with the client (the client always agrees and signs the protocol). The verification is then executed and reported in a Verification Report, with the method details included or referenced.
The extent of the verification will depend on the procedural and sample complexity but as a minimum the verification will require demonstration that the performance parameters (e.g. System Suitability Tests) specified in the method have been met with the matrices to which the method is being applied (typically analyte recovery assessment). For HPLC assay methods it is sometimes necessary to carry out a limited linearity assessment due to flow cell differences. Guidance on verification of Compendial Procedures is also given in USP Chapter <1226>.
Agenda1 has significant experience in the verification 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)