We have wide experience in analytical method development, validation and verification for the pharmaceutical, medical device and healthcare industry sectors including working with clients carrying out method validation work to meet regulatory requirements, and for internal cGMP needs.
We agree an approach with the client, usually in discrete costed sections to control the overall programme cost. The work can include analytical method development from scratch, or changing/improving existing methods. Our experience includes, small and large molecules, also polymers, plastics, nicotine-based products, bone substitute and similar medical device products.
We are happy to produce our own Validation Protocols, or work to formats provided by our client. 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 agreed with the client.
Method verification is used to demonstrate that a standardised published method can be run effectively in each laboratory.
The requirements for method verification are 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 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 (for example 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.