GXP Analytical Method Development, Validation and Transfer

Cormica provides an unrivalled breadth of analytical solutions, techniques and applications to the pharmaceuticals, medical device, healthcare, agrochemicals, biocides, food and feed sectors, including pesticides.

Method Development and Validation

Cormica is focused on problem solving and delivering high quality analytical and laboratory support. Using our extensive range of equipment, we develop and validate bespoke analytical methods to meet customer needs – encompassing the testing of everything from raw materials and pure active ingredients through unusual sample types, challenging formulations, and finished products of all types. 

Similarly, client, regulatory, monograph or literature methods can be readily established in-house at Cormica, via a documented method transfer or technology transfer. Following the method development / establishment phase, a pre-validation assessment determines the precision and robustness of the methodology, and allows for maximum confidence before proceeding to formal validation.

Method validation / verification is undertaken against a defined protocol / study plan, pre-approved by the customer and quality assurance, the scope of which can be tailored to be stage appropriate for the development status of the product and for the source of the analytical method.

All standard validation parameters are included, as appropriate for the technique and the sample type, as per ICH Q2 (R1), SANCO 3030/99 Rev 5, relevant technique specific guidance, e.g. USP <232> / <233>, and in-house validation SOPs.

For impurities methods, forced degradation studies (acid, base, oxidation, light, heat) are included as part of the validation process. A detailed validation / study report is shared with the customer for review.

Method Transfer

Method transfers can be undertaken with Cormica acting as the originating or receiving laboratory, as required. Transfer is against a defined protocol / study plan, pre-approved by the customer and quality assurance.

The approach undertaken can be tailored depending on the complexity of the method, the development status of the product, and the extent of the validation previously undertaken by the originating laboratory.

• Comparative Testing
  • One or more selected batches of material are analysed by the receiving laboratory in accordance with the test method, and the results are compared with the results obtained by the originating site for the same batches
• Method Revalidation
  • Specific validation elements are repeated at the receiving site to show that the method can meet the requirements for the intended analytical application
• Co-Validation
  • The receiving site participates in the execution of one or more elements of the validation being undertaken