OBJECTIVE
To have a Standard Operating Procedure for transfer of analytical and micro test methods and verification
SCOPE
This procedure is applied as the Standard Operating Procedure for transfer of analytical test methods.
RESPONSIBILTY
QC Executives
QC Manager
PROCEDURE FOR TRANSFER OF ANALYTICAL TEST METHODS
The test methods will be received (along with validation details), verified for suitability and used for regular analyses
A method transfer protocol will be prepared which will include the following
The analytical method
Method validation details
Training and evaluation of analysts
Verification of method performance
Performance of analysis at recipient lab
Evaluation of results between laboratories
Conclusion of method transfer
The responsibilities of transferring lab are briefly as follows
Provide method specific training, if required
Assist in analysis of quality control test results
Propose acceptance criteria for method transfer
Provide method validation details
Provide details of equipment used and any secondary reference samples
Provide approved test method
Execute the transfer protocol
Compile and approve transfer reports
The responsibilities of recipient lab are briefly as follows
Ensure that adequately trained and experienced personnel are in place
Review analytical methods provided by the transferring lab
Formally agree on acceptance criteria before executing the protocol
Ensure that necessary equipment for transfer is available and are qualified
Execute transfer protocol
Review and approve transfer reports
The recipient lab would perform verification of the method by performing the following
Linearity and range of the test method
Accuracy
Specificity
Repeatability
Reproducibility
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