In response to the pandemic, the World Health Organization has routinely updated their website with the latest news and information. As such, they also maintain one of the most comprehensive sets of regulations relating to the storage, handling, and transportation of time and temperature sensitive pharmaceutical products. These regulations are important to ensuring the efficacy of these pharmaceutical products and could be crucial to the distribution of a COVID-19 vaccine around the world.
The WHO’s Good Distribution Practices (GDP) Regulations
Keeping that in mind, we are going to examine the WHO’s good distribution practices (GDP) regulations and see how Cold Chain Packing & Logistics can ensure that your shipments are handled in compliance to these regulations which include the transport and delivery (monitoring systems, packaging types, labelling, etc) of today’s time and temperature sensitive pharmaceutical products to locations all over the world.
Temperature-controlled transport operations by road and by air of time and temperature sensitive pharmaceutical products must be carried out according to a very specific set of regulations. These globally recognised regulations focus in great detail on:
- Identifying and controlling risk.
- Managing refrigerated road shipments including pre-shipment actions, shipping day: actions at point of origin, actions during transit, arrival day: actions at destination point(s), and post shipment actions.
- Managing passive container road shipments including pre-shipment actions, shipping day: actions at point of origin, actions during transit, arrival day: actions at destination point(s), and post shipment actions.
- Air transport processes.
- Air transport labelling for TTSPPs.
- Managing air shipments including pre-shipment actions, shipping day: actions at point of origin, shipping day: actions at departure airport by freight forwarder, shipping day: actions at by air carrier and ground handlers, arrival day: actions at destination, and post shipment actions.
Cold Chain Packing & Logistics Custom Tailored Solutions
Cold Chain Packing & Logistics provides custom tailored solutions based on the World Health Organization’s good distribution practices (GDP) regulations as well as Saudi FDA guidelines. We base our service on the World Health Organization’s User Requirements Specification (URS), which includes:
- The temperature and humidity parameters that must be maintained for each product or product type; these parameters are determined by the product label, or when acceptable, the manufacturer’s stability data.
- The transport mode and/or vehicles to be used.
- The required level of service.
- Acceptable levels of risk to product and performance.
- The types of packaging.
- The types of temperature and humidity monitoring devices to be employed and the acceptable level of accuracy of these devices.
- Specific service actions such as go/no-go decision-making in the event of a temperature excursion event, or more complex analytical data gathering and reporting requirements.
By following the WHO regulations for transportation of time and temperature sensitive pharmaceutical products and adhering to our own industry best practices and commitment to ensuring high levels of customer satisfaction, Cold Chain Packing & Logistics has fast become the global leader in the temperature-controlled pharma logistics industry.
Contact Cold Chain Packing & Logistics
To learn more about why a temperature-controlled pharma logistics company is important to the global distribution of your life saving pharmaceutical product, contact Cold Chain Packing & Logistics today and speak with a Pharma Logistics distribution expert who can answer any questions you might have.
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