At JET8, we offer high-quality and reliable shipping services for pharmaceutical raw materials (intermediates and active pharmaceutical raw materials (API)) in compliance with GMP/GDP standards. We provide innovative solutions for customers who require strict temperature control and security measures in pharmaceutical development, manufacturing, and distribution.
Compliant API Shipping with Various Countries' Regulations and Guidelines
Depending on the destination country, GMP compliance certification may be required for the export of pharmaceutical raw materials. Just like with the import and export of finished pharmaceutical products, the pharmaceutical authorities of each country have stringent regulations to protect the health of their citizens. Imports, in particular, undergo scrutiny. When exporting from Japan, it is crucial to adhere to the import and sales regulations of the destination country and make adequate preparations.
| Country of Origin | Regulatory Authority | Laws and Guidelines |
| Japan | Ministry of Health, Labor, and Welfare (MHLW) | Good Distribution Practice (GDP) Guidelines for Pharmaceuticals |
| USA | U.S. Food and Drugs Administration (FDA) | Federal Food, Drug and Cosmetic Act: FDCA |
| EU | European Medicines Agency (EMA) | Good Manufacturing & Distribution Practices |
| Thailand | Food and Drug Administration of the Ministry of Health | Food and Drug Administration Thailand |
| Myanmar | Food and Drug Administration of the Ministry of Health and Sports | Food Import Recommendation |
JET8’s pharmaceutical transportation service provides support from researching the regulations and requirements of each country involved in pharmaceutical raw materials (Intermediates and API) imports and exports to the preparation of documents that comply with these regulations and requirements. We can assist with both imports and exports, so please feel free to contact us.
JET8’s Original SOP
GMP / GDP-Compliant Shipping Service
JET8 has a comprehensive set of original Standard Operating Procedures (SOP) and consistently adheres to GDP standards in international product shipping. We prioritize the quality maintenance of pharmaceutical products, maintaining the highest standards in all aspects of quality management, including temperature control during transportation, ensuring traceability, appropriate packaging, and labeling. Cargo handling is carried out in strict complains with GMP and GDP guidelines, as well as the standards set by the International Air Transport Association (IATA).
API Shipment Thorough Temperature Management
To maintain product quality, we rigorously manage temperature control during shipping. By arranging packaging and shipping vehicles following GDP guideline-compliant SOPs, we ensure that products are transported within the recommended temperature range, preventing quality degradation due to temperature fluctuations.
Monitoring and Records
We not only maintain temperature records during shipment but also manage cargo receipt, delivery, and opening records to ensure product traceability. For clients with specific requirements, we offer the option to include loggers that can measure real-time data, including temperature, humidity, light levels, and location information.
Risk Management
We evaluate all risks that may occur during transportation and implement appropriate risk management measures. In the event of any deviation from the transportation plan, we will promptly respond and safeguard your cargo with an appropriate action plan.
Product Handling
- Pharmaceuticals (general pharmaceuticals, veterinary pharmaceuticals, etc.)
- Medical devices (medical examination equipment, syringes, etc.)
We will carefully listen to the transportation details of our customers, who are experts in pharmaceutical transportation and arrange appropriate transportation following Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) guidelines, and the International Air Transport Association (IATA).
Shipping Temperature Ranges
- -60℃～-80℃
- -15℃～-25℃
- +2℃～+8℃
- +15℃～+25℃
- +1℃～+30℃
We arrange appropriate packaging materials and conduct temperature management following SOPs, adjusting cooling agents to achieve precise temperature control based on the size of your cargo and temperature requirements. Depending on cargo size, we can also arrange for airfreight active containers or reefer trucks. Temperature mapping has been performed for your assurance.