For compounding pharmacies regulated under section 503B, electronic record data integrity concerns are increasing in regulatory and customer visibility. The concepts of good data integrity practices is not new. Yet an organization can inadvertently open itself up to serious problems with their electronic record integrity if proper operating and computer system validation procedures are not […]
Read MoreThe U.S. Food and Drug Administration (FDA) recently issued a Warning Letter to a Japanese bio-chemical manufacturing company. The Warning Letter summarized significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). The letter cited non-compliance with section 501(a)(2)(B) of the 21 U.S.C. 351(a)(2)(B). The FDA inspection observed many data integrity non-compliances included retesting and manipulation […]
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