Atul Bioscience Ltd. — Health Canada Inspection Findings

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures. The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material.

The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.

The quality control department did not undertake all of the required activities.

The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

The recorded information or details were inadequate.

The validation of equipment or the planned maintenance of equipment was inadequate.

The creation, maintenance, processing, and/or review of laboratory data was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.