Section 6.6 of Q7A indicates that the review of laboratory records should include “the date and
signature of a second person showing that the original records have been reviewed for accuracy,
completeness, and compliance with established standards.” Typically, second-signature on
weighing in the laboratory is not done for GMP reasons; if you’re handling narcotics or controlled
substances, that’s a totally different issue. In order to review accuracy, there typically has to be a
check on the calculations. Review for completeness would be to confirm that all of the work has
been done, and everything has been filled out fully. Compliance with established standards would
be accomplished through comparison of the result against the expected result.
Having a second person always watching over your shoulder to witness everything you do is an
unreasonable expectation. This could create havoc in the laboratory and probably impede the
proper and efficient analysis of materials and drug products in the lab.
