Method Development and Validation

Method Development and Validation Services

Galbraith Laboratories provides method development and method validation services to clients that have a regulatory need to use a validated procedure or to clients that just want the additional assurance the method is working as intended.  These projects begin with a needs assessment followed by a formal proposal from Galbraith. Galbraith prepares the proposal based on a discussion of the client’s needs, applicable regulations, product specifications, technical requirements and historical analysis of the sample (if any).

Method Development

Galbraith begins by performing all validation experiments in a pre-validation, non-regulated mode. The initial methodology used in these experiments can be a general Galbraith procedure or a client procedure. This step gives Galbraith the opportunity to refine the method for the sample and to establish attainable acceptance criteria for the validation protocol.

Validation Protocol and Procedure

Once the development work is completed, Galbraith will prepare the procedure and protocol. Procedures are written to include a description of all instruments, reagents/standards and steps required to perform the method for the client’s sample. Protocols are typically designed to meet the ICH and USP <1225> requirements, though protocols may be designed to meet other guidance as well. Experiments are usually conducted to measure Accuracy, Repeatability, Intermediate Precision, Specificity, Linearity, Range, Limit of Detection and Limit of Quantitation. Once the protocol and procedure have been approved by Galbraith Management, Galbraith Quality Assurance and the client, the validation experiments will be conducted.

Validation Report

Once the validation experiments are completed, the data will be analyzed and a validation report will be prepared. The report will contain all of the validation results, a statistical analysis of the data and overall conclusions regarding the validation of the method. Once completed, the report and all associated data are inspected by Galbraith’s Quality Assurance before it is sent to the client for approval. When all approvals have been obtained for the validation report, the method is considered validated and may be used for routine analysis of samples.

For More Information

Please contact us to request a detailed discussion of your project needs and for a free quotation.