I need to confirm the specificity of the peaks in my HPLC. This validation is for the commercial analytical test for a protein-based pharmaceutical. One of our researchers working out of the USDA has an previously performed an SDS Page process on fractions. We'd like her to repeat it for the validation. However, her lab is non-GMP. Have others done this? Will it open the lab up to an audit for the FDA?
Thanks!
No. Since specificity is a part of analytical method validation per ICH Q2(r1) it must be performed in a cGMP lab. Pick a commercial lab that has been FDA audited, not USDA.
cGMP in a lab, means the chemist's work is reviewed by a 2nd chemist before the result is signed and approved by the manager. There is a reason why commercial labs are FDA/EU audited, its costs more. And no, it will not subject you to an FDA audit unless you are the lab of record in a drug approval or recall process.
You can have a 'ton' of PhD's (like on stem cells) but be totally incompetent on process!
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