Article: Success Factors and Best Practices for Commercial Temperature Controlled Shipments
By World Courier |
1. What are some recent trends for packaging solutions for Commercial Pharmaceutical Products?
A: There is an increased use of risk assessment to determine the best-suited type of packaging solution to be used. Lane characteristics such as infrastructure, network, maturity, and capability of key stakeholders such as airlines are considered; as well as product characteristics. The product life cycle, stability data (or lack of), replacement time and cost, market demand are key factors of how much risk a company is ready to take when transporting pharmaceutical products. This process is driven by the changing environment, as we have seen in the past 6 months, where most of the factors evaluated for risk assessment have changed dramatically.
2. How was the Thermal Packaging Supply affected during the COVID-19 pandemic?
A: For the re-usable systems like the active containers and Cocoons, they are positioned around the world according to the needs of customers. Due to the pandemic, the air cargo landscape has changed severely and the customer shipping patterns have also been impacted. However, the industry adapted and air cargo still managed to keep the supply chains functioning through dedicated cargo freighter operations, utilization of cargo capacity in passenger aircraft, and charters.
The supply of the single-use packaging varies, depending on the specific type, inventory levels, location of distributor, and manufacturer.
3. How can our company be certified for Good Distribution Practice (GDP)?
A: Check with your local regulatory body to find out whether your company’s activities fall within the scope of GDP. If they do, you can apply for certification with the respective regulatory body.
4. What would be the typical process of getting a GDP Certificate and how long will the whole process take?
A: The typical process is to first develop your company’s Quality Management System (QMS) to align with Good Distribution Practices. This means having elements within the QMS that cover areas reflected in the regulations like having Standard Operating Procedures, Change Control, Risk Management, etc. Some companies will decide to develop this internally while others will work with consultants to develop the QMS and assist in the preparation of the audit from the authorities. This might take from weeks to months to develop depending on your size.
5. What are the practical benefits of using Good Distribution Practice Certified companies such as World Courier?
A: It makes it easier for GDP certified companies to qualify the vendors/And if required, provide evidence to the regulators that their vendors comply with GDP. On another level, vendors that comply with GDP also will have a process for improvement (Corrective and Preventive Actions (CAPA), Risk Management, Change Control) which are designed to mitigate risks of mishandling or prevent reoccurrence of similar mistakes.
6. What is World Courier's experience in changing risk profiles during COVID-19? Did risks increase or decrease during the pandemic?
A: World Courier’s experience is that because of disruption to the aviation industry, the difficulty in sourcing for the appropriate flights increases all other risks of handling (temperature control for example). At the same time, with Government imposing lockdown measures, World Courier implemented solutions such as working from home, contactless pick-up and deliveries, to be able to service our customers during COVID-19.
From this experience, the risks did increase, but at
the same time, our Contingency Plans (Business Continuity Plans) were tested
and our mitigation measures were effective.