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KM-USA wrote:
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This is the critical bit:
"5. Your firm has failed to maintain complete records of all testing and standardization of laboratory reference standards and standard
solutions [21 CFR 211.194(c)].
A laboratory reference standard is one that has been made up in the testing laboratory - the finding simply asks the lab to check its own work. A certified reference material has been prepared and certified (with uncertainty and traceability) in a laboratory which is certified and/or accredited by a national body, which is itself part of a huge international network in which everyone checks everyone else and agrees on the basis of audited performance that results (e.g. the certified concentration of a certified reference material) can be accepted as "correct". So for a routine QC lab for example, it makes sense to check standards prepared in house, it does not make sense to check certified reference materials - for reasons that have already been discussed earlier in the thread.
Peter