Contract Method Transfers

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

I have been asked to begin transferring the contract and USP methods my lab is currently using to test raw materials. Should I convert these contract methods to in-house documents and then write validation protocals for each? What would I use for a reference sample or a target value (the specification mean?)? Also, for USP methods is a transfer required and if so, can the test simply be run in triplcate to generate an acceptable RSD or is more nessesary?
What are the FDA requirements when using contract and USP methods? Also, when sending any testing out to a contract lab, what are the responsiblities of the originating lab? Are we required to validate their test methods or simply review them? How should their raw and final data be handled by our lab??

Thanks in advance for any comments/ advice!!

2

for any Pharmacopial method used for testing of raw material or API, it doesn’t required validation even if it transfer form doner lab to receiving lab. If your raw material or API is claming USP you have to perform testing as per USP that doesn’t required validation of analytical method.