A company recently received this 483 observation:
… Drug products are not stored under appropriate conditions of so that their identity, strength, quality, and purity are not affected.
a. The temperature mapping studies for the Finished Goods Warehouse and the Raw Materials Warehouse (protocol # …. ) were conducted in the fall over a limited period of 24 hours. The outside temperature during these studies were not documented to show that these studies were conducted during the representative worst case outside temperatures.
b. We observed packaged finished drug products that were stored in the Components Warehouse that is not temperature monitored. Multiple finished drug products were found stored in the non-temperature controlled Components Warehouse.
c. We observed excipient … lot # … with a stated storage condition of … stored in the raw materials warehouse that has temperature specification limit of …
d. Reserve samples are stored in a room that also stores various materials in boxes from the last 10 years. Several of these boxes were found to be leaking materials, soiling the storage racks adjacent to the reserve sample racks, and the floor of the room.
For more observations pertaining to manufacturing controls, see Issue 1051 available today. It also has observations pertaining to laboratory controls, API manufacturers and medical device manufacturers.