1Deviation, CAPA, and investigation
Deviation form, “SOP Deviation 2,” describing a deviation from SOP B01.03: Temperatures were not recorded for the refrigerator used to store test article in December 2018. b. Deviation from SOP A03 (“Archival Procedures”), which requires submission of the Archive Submission Form (submission worksheet) to record physical data and documentation pertaining to the assigned GLP study submitted to the archive, was not authorized by the study director and was not documented in the…
2Laboratory and QC controls
The quality assurance unit (QAU) failed to assure that the reported results in the final study report accurately reflect the raw data of the nonclinical laboratory study [21 CFR 58.35 (b)(6)]. The QAU must review the final study report to ensure that the reported results accurately reflect the raw data of the nonclinical laboratory study. The QAU at your testing facility did not adhere to these requirements. Specifically, the following observations/data were not accurately…
3Deviation, CAPA, and investigation
The study director failed to authorize all deviations in the study from standard operating procedures and ensure the deviations were documented in the raw data [21 CFR 58.81 (a)]; The final study report did not include a description of all circumstances that may have affected the quality and integrity of the data [21 CFR 58.185 (a)(9)]. The study director must authorize all deviations from standard operating procedures in a study and document all study deviations in the raw…
4Equipment and facility
The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study [21 CFR 58.33(f)]. The study director must ensure that all raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study. The study directors at your testing facility for both Protocols (b)(4) and (b)(4) failed to adhere to this…
5Deviation, CAPA, and investigation
Deviation form, “SOP Deviation 1,” describing the following deviations from SOP B01.03 (Defining, Manually Reporting, and Correcting Raw Data) and SOP F07.01 (Dose Formation Analysis Range): (a) Eye examination for Animal 3502 was not documented at the time of the actual eye examination. (b) The batch number of the vehicle was incorrectly documented as the lot number on formulation sheets. (c) Mean concentration for the formulation analysis samples for Groups 2, 3, and 4 were all outside of the acceptable theoretical difference range.
