As the leading manufacturer in the mass production of Liposomes in Asia, TTY implements strict control over API management, product storage, and cool chain logistics to secure drug quality and stability to international standard and ensure customers’ safety. Achieving the purpose of United Nations Sustainable Development of Goal 3 "Good Health and Well-being" and Goal 12 "Responsible Consumption and Production".
<| 項次 | 步驟 | 步驟陳述 |
|---|---|---|
| 1 | API Management | Despite Taiwan's API management not yet being under GDP, the Chungli factory has followed the international management system and is ready to follow potential regulations in Taiwan. API storage and management comply with the GDP of PIC/S GMP. Liposome is a product under cold chain management. Since the arrival at the factory, the API and excipient of Liposome are stored in a temperature-controlled warehouse until entering the manufacturing process. |
| 2 | Product Storage | Once the products are packaged, they are immediately stored in a warehouse at 2℃ ~8℃. To ensure 24-hour temperature control, all refrigeration warehouses are equipped with 2 air conditioners and fans, so either can cover a faulty air- conditioner should the occasion arise. All refrigeration warehouse equipment has backup power to prevent equipment malfunction or power disruption. General maintenance of refrigeration warehouses includes twice-daily inspections and continuous monitoring via data loggers and alarms. If temperatures deviate from the specified range, flashing lights and sound alarms activate, prompting security to notify relevant authorities. Access to refrigeration warehouses at the Chungli factory is restricted to authorized personnel only, minimizing temperature fluctuations caused by unnecessary entry and exit. Additionally, Temperature Mapping Qualification (TMQ) is conducted during the coldest and hottest seasons to ensure storage temperatures meet requirements. |
| 3 | Cold Chain Product Transportation |
2℃~8℃ end-to-end temperature control must be maintained during the transportation and delivery of Liposome to hospitals and clients. The warehouse and QC departments have conducted several visits and audits to find a qualified logistics company that can ensure the storage, delivery, and temperature control of LN2, gel packs, and dry ice. TTY has signed agreements with select logistics companies, which have been designated as qualified cold chain logistics suppliers. Our Liposome products are transported from the refrigerated warehouse at the Chungli factory using specially designed refrigerated delivery boxes made from qualified materials. Each shipment includes clear guidelines on the maximum number of times ice can be used, its effectiveness period, and other standard procedures. Additionally, the package is sealed using TTY-logo void tape with a 3M Monitor Mark, ensuring security and integrity during transit. TTY invests nearly a million NTD annually on WHO-certified 3M Monitor Marks to uphold quality standards. There were no reported cases of abnormal temperatures in 2024. Cold chain delivery by ground or by air to the Taiwan mainland, Kinmen, and Penghu should not exceed 24 hours from pickup to proof of delivery. 3 statistic tests and route dynamic tests are each performed for different box sizes, and the shortest delivery time should be selected and recorded as a standard for general transportation management. Validations should be run once every summer and winter to eliminate various factors affecting temperature changes during transportation. |
| 4 | Continuous Improvement | To enhance the stability of its cold chain, TTY has streamlined the design of coolers' inner boxes, standardizing the material and volume, and the new inner box outperforms the original, offering more stable temperatures to ensure the product quality, and also to simplify material and storage management. In response to inventory and shipment increased, and optimized the cancer factory production line, TTY has also completed the expansion of cold storage space and replacement or purchase additional cold storage warehouse equipment in 2022~2023. In the future, TTY will continue to improve and enhance cold chain management in response to product storage and transportation needs. |