Hi everybody! I was wondering if there's a specific answer (I mean cited reference from FDA, or probably other drug administration agency - MHRA?) I've been looking for an answer all over the internet, the FDA website and in the books but all that I've found are some non specific answers like: "from my experience the retention time difference can be up to 2.5 %..." or something like that.
Thanks for all your answers in advance!
@Milan
Here is an earlier ResearchGate thread on a question similar to yours. Official references were included:
https://www.researchgate.net/post/FDA_Guidelines_for_HPLC_method_development_and_validation
Here is official guidance from the United States Pharmacopoeia (USP). See the answer to question 3. (Relevant documents include 621 and 1224).
http://www.usp.org/frequently-asked-questions/chromatography
Here is an older webpage on System Suitability Testing, with references to older guidelines from FDA-CDER (see footnotes in article):
http://pubs.acs.org/subscribe/archive/tcaw/10/i09/html/09dong.html
Statistical analyses of data acquired on your specific HPLCs are likely to be critical considerations during an audit. Aside from absolute values, you may be asked to demonstrate reproducibility and account for any biases. Here are some official training documents from the US FDA and USP:
http://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM173317.pdf
https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c621.pdf
https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c1224.pdf
http://www.fda.gov/downloads/Drugs/.../Guidances/UCM134409.pdf
http://www.fda.gov/downloads/Drugs/.../Guidances/UCM134409.pdf
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm386366.pdf
Here is a presentation from a biotechnology/pharma consulting firm in the USA:
http://www.ncbiotech.org/sites/default/files/BPD%20Method%20Transfer%2012-8-11.pdf
Hope these references help.
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