Assay Transfer and Validation: Key Points to Consider
Assay transfer and validation are critical steps in the drug development process. These steps ensure that the results generated in one laboratory using a specific method can be reproduced in another laboratory using the same method. The process involves transferring an analytical method from one laboratory to another and then validating the method in the recipient laboratory. Here are some key points to consider when conducting assay transfer and validation.
Validation Plan
Before transferring an assay from one laboratory to another, a validation plan should be created. The validation plan should clearly outline the validation strategy, the acceptance criteria, and the responsibilities of the involved parties. The plan should also define the scope of the validation, including the analytical method, the equipment used, and the personnel involved in the validation.
Transfer Protocol
A transfer protocol should be developed to ensure that the assay is properly transferred from the sending laboratory to the receiving laboratory. The protocol should outline the method transfer process, such as the transfer of documents, the shipment of samples, and the training of personnel on the new method. The protocol should also include the necessary acceptance criteria for the method transfer to be considered successful.
Robustness and Ruggedness
During assay development, it is essential to determine the robustness and ruggedness of the method. Robustness refers to the ability of the method to remain unaffected by small variations in the experimental conditions. Ruggedness refers to the ability of the method to remain unaffected by variations introduced by different operators, laboratory environments, and equipment. These factors should be considered during the assay transfer process to ensure that the method is robust and rugged enough to be used in different laboratory settings.
System Suitability
System suitability testing is essential for ensuring that the method is working under optimal conditions before sample analysis. System suitability parameters are established during development and must be met through the analysis of a standard sample or a control sample. The recipient laboratory should verify the system suitability parameters before starting sample analysis to ensure that the analytical method is being executed correctly.
Continued Performance Verification
Assay transfer and validation are not a one-time process. To ensure that the method remains valid and reliable, the user should conduct continued performance verification to ensure the method’s robustness and precision. The performance verification process should include testing a standard sample or a control sample at regular intervals, and documenting the results obtained.
In conclusion, assay transfer and validation are critical steps in the drug development process. It involves transferring an analytical method from one laboratory to another and then validating the method for use in the recipient laboratory. Key points to consider during assay transfer and validation include having a validation plan in place, developing a transfer protocol, considering robustness and ruggedness, verifying system suitability, and establishing continued performance verification. By following these key points, the user can ensure that the assay is reliable and reproducible across different laboratory settings.