Method development and validation
Concept Life Sciences is a specialist CRO 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 Concept, 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.
Figure 1 (left): Validation: Assay, Impurities, Elemental Methods / Figure 2 (right): Validation: Materials Characterization, Raw Materials Methods, Verifications
Method transfers can be undertaken with Concept 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.
- One or more selected batches of material are analyzed 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
- Specific validation elements are repeated at the receiving site to show that the method can meet the requirements for the intended analytical application
- The receiving site participates in the execution of one or more elements of the validation being undertaken
Validated/verified methods can be transferred to the customer or a third party or can be utilized in-house at Concept for:
- QC Batch Release Testing
- QC Reference Substance Qualification
- ICH stability studies
- GLP 5 Batch analysis
- GLP storage stability
- Regulatory submissions
- Cleaning validation / verification
- Occupational hygiene
- Plus many others
- Method development, establishment, verification, and validation to GMP and GLP
- Method transfer to and from customer laboratories, Third party transfers
- Quantitative methods / Limit tests / Qualitative methods
- Assay, Impurities, Physical properties,
- API, Excipients, Raw materials, Formulations, Finished Products, Packaging
- Compliance with ICH Q2 (R1), SANCO 3030/99 Rev 5, other relevant Regulatory guidelines, Pharmacopoeial methods, plus internal SOPs
- Wide range of analytical techniques:
- Separation sciences
- Specialized, high-end product characterization
- Elemental analysis, Physico-chemical testing, Raw materials methods, Physical properties