By Carla Reed, president, New Creed LLC
Over the past few decades, many companies have spent time and capital investment in assessing and mitigating risk factors across the extended supply chain. However, even for those companies that have designed and implemented state-of-the-art operational supply and logistics networks, there is always risk that products may be impacted by variations in temperature, humidity, or other deviations from ideal conditions at any stage across the chain of custody.
Rules and Regulations
Regulatory authorities require that the manufacturer ensures product quality not only during storage and transportation but until it is used by the patient. The new EU regulations on good distribution practices (GDPs) are becoming the standard for the global movement of pharmaceutical materials and products. These regulations enforce the same level of care that is required for current good manufacturing practice (cGMP) compliance into the storage and distribution environment. cGDP, with appropriate guidelines and best practices, has been widely adopted by many health authorities around the world. (For a list of relevant international cGDP regulations, see the References and Resources section below.)
Environmental monitoring during storage and transportation is a requirement of cGDP and should include evaluating and protecting the shipment from the impact of humidity, light, oxygen, shocks, pressure, vibrations and X-rays — in addition to time, temperature monitoring, and control.
From the time the shipment departs the point of origin until it arrives at the final destination, it could be exposed to many situations that could compromise the quality and integrity of the materials/product contained therein. These could include transportation delays, extended periods where the shipment is exposed to the elements (e.g., tarmac holding time for air shipments), misrouting and/or trans-shipment, misplacement in a transit storage location, customs inspections, and/or detentions. And in even the most well-planned shipment routes there is the probability of unexpected weather variations, which can impact shipment time and exposing shipments to less-than-ideal conditions. Irrespective of the detailed risk review and shipment planning process, a shipment may experience one or more temperature excursions.
An excursion (negative or positive temperature deviation) can cause a change in the state of the product, which will then have to be quarantined until a CAPA (corrective and preventive action) has been initiated, a root cause analysis completed, a risk assessment performed, and the CAPA closed. In a best-case scenario, the shipment can be released but could have experienced delays of several weeks or even longer.