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Hi!
Please can you help me understand the legislative (CFR) requirements for extractables and leachables for a US marketing application (BLA):
If I perform an extractables and leachables risk assessment that indicates no risk for any contact materials used for drug substance or drug product manufacture - must I still perform a E and/or L study?
If so, can I perform a "worst-case" leachables study or is there a mandatory requirement to perform an extractables study?
Thank you very much in advance for any expert insight!