The Canadian Association for Pharmacy Distribution Management (CAPDM) recently conducted a survey among its members asking for observations made by the Health Products and Food Branch (HPFB) Inspectorate of Canada related to Storage and distribution between June 2005 and April 2007. A review of those findings, as well as those made by the HPFB Inspectorate were reviewed at the Temperature Control Coalition Workshop in July.
Eleven companies responded. Three had observations, five said they were not inspected during that time period, and three admitted they had no related observations.
They were:
No procedure for product transportation conditions. Incoming inspection of shipment from fabricator did not include criteria for packaging and shipping conditions. No procedure for monitoring data for shipping within Canada. Freeze / Thaw data not available (Risk 3).
Temperature profiling of the ambient warehouse was performed in March 2006 rather than at known periods of external temperature extremes in the summer and winter (Risk 3).
Certificate of calibration was not available for 2 of the TempTale data loggers randomly selected for incoming products. Release procedure for drug products did not include confirmation of calibration of the data loggers (Risk 3).
Although Freeze / Thaw and accelerated data were available, the effects of transportation on the quality of the drug products has not been assessed (Risk 2).*
* made before Guide-0069 came into effect (10/06)
It's tough to draw any conclusions or reveal any trends from such a small sample of CAPDM's overall membership. But it is commensurate with the types of observations as reported by the HPFB Inspectorate itself who states that:
"26% of observations cited deficiencies in appropriate handling, storage and shipment of drug products with respect to temperature requirements."
"50% of observations related to Guide-0069 [Temperature Control of Drug Products during Storage and Transportation] made at wholesalers."
Examples of the 2006-2007 observations reported by the HPFB Inspectorate include:
Absence or incomplete written procedures for transportation of drug products.
Examples: No procedure to monitor storage and transportation conditions, such as temperature, humidity, stock rotation and any other precautions necessary to maintain quality and safe distribution of the drugs.
No transportation procedure to ensure products lacking freeze/thaw stability data are transported in heated carriers during winter months and verification of adequate transport conditions is conducted upon receipt of shipment.
Absence or inadequate temperature control and monitoring during storage using calibrated thermometers.
Absence or incomplete temperature mapping of storage facilities.
Examples: No temperature monitoring in storage areas. Temperature mapping not conducted in warehouse to determine appropriate location for temperature monitoring. Procedures not established for transportation conditions of drug products.
