La gestion des feuilles de calcul et des enregistrements papiers sont au cœur des observations de l'injonction de l'administration américaine à cette société italienne.
1.Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
For multiple sterile drug product lots, your original data showed failing results, but data you reported showed passing results. This discrepancy was not adequately explained.
You stored original data in an “unofficial” and uncontrolled electronic spreadsheet on a shared computer network drive. Your analyst stated that original data was first recorded in this “unofficial” spreadsheet and transcribed later to an “official” form. This spreadsheet showed failing results above the limits you established in your procedure, PCH 035 Visible Particle Determination in use prior to September 1, 2014...
According to your analyst, a second reviewer may have determined that the number and type of particles originally recorded for glass, metal, fibers, and other particles were incorrect. However, no documentation showed that a second reviewer evaluated the results.
2.Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
Our investigator observed many copies of uncontrolled blank and partially-completed CGMP forms (e.g., environmental monitoring recordings, OOS forms, water testing sheets, and clean room entry and exit logs) without any accountability or oversight of your quality unit.
Our investigator documented that your employees used paper shredders to destroy critical laboratory and production records without the appropriate controls and procedures. Shredded documents included High Performance Liquid Chromatography (HPLC) chromatograms and a partially-completed OOS form.
These findings raise questions about the effectiveness of your quality unit and the integrity and accuracy of your CGMP records.