Buildings used in the manufacture, processing, packing, or holding of drug products must be maintained in a clean and sanitary condition, including pest control. According to 21 CFR 211.56(a), buildings should be free of infestation by rodents, birds, insects, and other vermin. There should also be written procedures that assign responsibility and describe in detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities. The written procedures should be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products.
A company recently received the following observation:
…. Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
Specifically, you have not established a quality system and written procedures assigning responsibility, providing a schedule, and describing in sufficient detail the methods equipment and materials to be used for pest control. Furthermore, you do not have devices designed to control and exclude flying and crawling insects from your receiving area, warehouse, and production areas. The following objectionable conditions were observed in your facility:
a. Dead flying insects were observed adhered to an oily film below the door actuator on the inside of the personnel door in the receiving area.
b. Dead flying insects were observed in the windowsills adjacent to the … said to be used to package some of the … lots.
c. Dead beetle like insects were observed on the floor near the exterior wall adjacent to the … said to be used to package some of the … lots.
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