FDA inspected the Drug Testing Establishment of DRL (Dr.Reddy’s Laboratories) at Bachupally, Telengana India (FEI:3009483004) in Dec 2023; USFDA Investigator Saleem A Akhtar. The Form 483 issued cites discrepancies in sameness study conducted in 2016 between DRL drug product and RLD (Reference Listed Drug) samples for Evaluation of Sameness for Secondary Structure by CD Spectropolarimeter. In the sameness studies by measuring Circular Dichroism under different conditions of temperature and pH, all Laboratory data generated was not reported, data were invalidated, samples repeated. Review of metadata in the system showed creation of additional spectra. The discrepancies / Incidents were not reported to the agency in the sameness study report, until the incidents were discovered during inspection. It was also observed that in the Logbook of a pH meter used for pH adjustments during the Circular Dichroism test, page 100 was voided with a note that Page 99 is missing and there was no reasonable justifications. The CD spectra in the studies (original electronic data) were named in such a way they were not attributable to specific DRL batch / RLD samples. It was also observed that laboratory data was not recorded contemporaneously, sample preparation details were recorded in the analyst notebook on the next day of the test.
The laboratory do not have detailed control procedures in place to review technical data generated utilizing complex analytical techniques like NMR, ICPMS, Cryo-TEM, Ion Chromatograph, GCMS, LCMS and so on; there is no technique specific control procedures in place to review raw data generated by these equipment.
It was also observed during the inspection that several trainings of employee were overdue and SOP for Employee Training do not specify minimum number of days within which the employees have to complete the assigned training.
Developmental data (ARD Data) submitted to agencies as part of regulatory dossier or in query responses are primary basis of the product approval and shall be fully GMP compliant. FDA (as well as other agencies) can inspect the data during audits and observations of major GMP non compliances, data integrity observed during any inspections could be critical.
Leave a Comment
You must be logged in to post a comment.