YZ/T 0195-2024 in English
VALIDCold Chain Pharmaceutical Logistics Service
- Issued on:2024-11-15
- Implemented on:2025-02-01
- File Format:PDF
- Delivery:RFQ
| Standard No: | YZ/T 0195-2024 |
| Document status: | VALID |
| Title in English: | Cold Chain Pharmaceutical Logistics Service |
| Title in Chinese: | 医药冷链快递服务 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | RFQ |
| Issued on: | 2024-11-15 |
| Implemented on: | 2025-02-01 |
| ICS Classification: | 03.240-Postal services |
| Chinese Classification: | M83-Postal packaging |
| Professional Classification: | YZ-Post |
| Related Keywords: | cold chain express service system
cold chain pharmaceutical logistics service introduction interpretation added new cold chain management requirements cold chain interruption alarm disposal records verify chain guidelines data retention period |
Introduction
Interpretation of the core content of the standard
The YZ/T 0195-2024 standard builds a cold chain express service system covering the entire process of drugs and medical devices, focusing on standardizing the performance requirements of key equipment such as refrigerated trucks and refrigerated boxes, and establishing the industry benchmark of 5-minute temperature monitoring frequency and 5-year data retention period.
Comparison of key indicators of service conditions
| Elements | Requirements of this standard | Differences in ordinary express delivery standards | International GSP comparison |
|---|---|---|---|
| Temperature monitoring frequency | ≤5 minutes(≤2 minutes when abnormal) | No mandatory requirement | Complies with WHO cold chain guidelines |
| Data retention period | 1 year after the validity period (at least 5 years) | Usually 1 year | EU requires 3 years |
| Equipment verification cycle | Mandatory verification after new investment/renovation | No relevant regulations | Compliant with PIC/S standards |
Typical application scenarios
Biologics transportation case
A tertiary hospital commissioned SF Express to transport monoclonal antibodies (stored at 2-8℃). The service provider used verified insulated boxes for loading:
- Pre-cooled to 5℃ before packing, with built-in temperature recorder
- Twice the temperature limit alarm (7.2℃) was triggered during transportation, and the system automatically notified the dispatcher
- Scan the code to read the temperature curve during the entire process when receiving the package, and upload the acceptance data to the drug supervision platform simultaneously
Standard implementation suggestions
Enterprise Compliance Path
- Establish a two-person review mechanism to ensure the authenticity of temperature control equipment verification data
- Develop a blockchain evidence storage system to meet data tamper-proof requirements
- Design a layered packaging solution for special drugs such as insulin
Key points for regulatory attention
- Focus on checking the cold chain interruption alarm disposal records
- Verify whether the refrigerated truck door opening time meets the verification parameters
- Spot check the consistency of the accompanying document and the electronic waybill
Technology Evolution Analysis
Main breakthroughs compared to the 2017 version of the YZ/T 0162 standard:
- Added new cold chain management requirements for medical devices, covering new products such as IVD reagents
- Cleared the interface specifications of the cloud monitoring platform to promote data interconnection and interoperability
- Introduced the concept of risk grading management to distinguish the operating standards of products in different temperature zones
Loading PDF document...
Error loading PDF. Please make sure the file is valid and try again.
We also recommend
-
YZ/T 0194-2024 in English
Basic requirements for express packaging of fresh products
2024-08-08 -
YZ/T 0148-2015 in English
Express electronic-waybill
2015-12-14 -
YZ/T 0160.1-2017 in English
Postal industry encapsulation tape―Part 1:Traditional adhesive tape
2017-08-14
