Intertek ASG Laboratory, Manchester, UK

Analytical Method Development

Analytical Method Validation:

Pharmaceuticals and Biopharmaceuticals

Intertek ASG has extensive experience in analytical method development and analytical method validation for applications in pharmaceutical and biopharmaceutical products. Methods are developed and validated according to either a specific client protocol or Intertek ASG's own Standard Operating Procedure (SOP). Robustness studies are available as an option. Methods are validated in accordance with MHRA / FDA and ICH guidelines. All validation projects can be custom designed to meet customer's specific analytical requirements.

Intertek ASG is able to offer method development and method validation for a wide range of analytical technologies, and has in-depth experience in the application of these technologies to a wide range of intermediates, API's, formulations and finished pharmaceutical and biopharmaceutical products. The regulatory status of Intertek ASG allows these to be used at all stages of the pharmaceutical development and manufacturing pipeline. For specific advanced technologies, Intertek ASG is able to apply validated methods to provide specialist QC services where this represents the most cost effective solution.

Standard parameters for inclusion in a study by Intertek ASG include:

Specificity / Selectivity
Analyte Precision
Intermediate Precision
Linearity and Range
Accuracy
LOD / LOQ
Ruggedness
Standard and Sample Solution Stability
Robustness (optional)

Staff at Intertek ASG have worked with a wide range of companies, both locally and with multinationals, and are well experienced with the definition and agreement of a robust project scope together with the subsequent technology transfer of developed methodologies back to the customer organisation.