TTSPP is an acronym for Time and Temperature Sensitive Pharmaceutical Products, a category of particularly sensitive Pharmaceutical Products, when it comes to transport and delivery. This category includes, among other products, vaccines, which are critical for the worldwide public health efforts. Because of that, they are highly regulated, but you can learn more on how to optimize their transport and delivery in the RC REDOL article below.
General guides to good manufacturing practice (GMP), good storage practice (GSP), and good distribution practice (GDP) describe in detail how to handle these products. To apply these standards well, there are a number of essential systems that need consideration, which include:
• Product stability profiles
• Transport route profiling and qualification
• Temperature-controlled transport
• Temperature and humidity control and monitoring during transit
• Qualification of temperature-controlled road vehicles
• Calibration and verification of transport monitoring devices
• Shipping containers
• Shipping container packing
• Product handling during packing and transport
• Cleaning road vehicles and transport containers
• Transport of returned and recalled TTSPPs
Nevertheless, in less-developed countries, it can be harder to comply with the standards, which is why the World Health Organization produced a document aimed at ensuring readers in these countries are aware of the relevant GMP, GSP, and GDP implications. This document, Annex 9: “Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products”, approaches storage, transport and delivery from a specialized perspective over TTSPP management, and shows how the requirements can practically be achieved in countries where there are resource constrains.
But, what has this got to do with your production? Well, regarding the Transport and Delivery of Pharmaceutical Products, you too can have your operations run smoothly and efficiently. With an elaborate and concrete SOP (Standard Operation Procedure) that addresses all possible scenarios, it is possible to ensure you operate correctly, which will help avoid sanctions by the authorities.
RC REDOL can be your partner in this journey, as we provide the required know-how and experience for your organization to keep up-to-date with regulations and work under a correct quality management system. Contact us today and discover how we can transform your pharmaceutical products operations!
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