Lupin's document destruction dance
Like Apotex and Hill, Lupin ran afoul of master batch record requirements. Lupin's violation was straightforward enough: Inspectors found batch records for unexpired drugs in a document destruction area during a facility inspection in Bhopal, India. The pending destruction violates rules requiring such records to be kept for a year following expiration. The result of the November 2008 visit was a May 7, 2009, warning letter WL: 320-09-05.
But here the story takes a twist: The records were found in a facility other than the one used for manufacturing the drug. To make matters worse, corporate management stated that the inspected plant had "no involvement in any way" with the plant where the drug is made. Yet inspectors observed 20 boxes containing documents and files from the manufacturing facility.
"Please explain the discrepancy in the information given by your quality management to our investigators," the letter says.
Lupin was also written up for failure to follow procedures designed to prevent microbiological contamination of drug products. Specifically, not all personnel who entered the aseptic filling area are monitored. "Personnel such as maintenance, cleaning, supervisors, and operators were not required to follow written procedures that they be microbiologically monitored," says the warning letter.
In addition, regulators found deficiencies in Lupin's controls to prevent contamination in areas used for aseptic processing. "Smoke studies were inadequate in that they were not performed under dynamic conditions and the results were not recorded for subsequent review," according to the letter. The company's failure to routinely maintain manufacturing equipment according to a written program designed to assure proper performance was also noted.