SPLine, as a member of the MEDIPAL group, will leverage our group's advanced distribution management function, such as strict quality control, response to various temperature zone logistics and infallible and high level traceability functions.
Business Category : Logistics / Transportation / Warehouse、Regenerative medicine treatment、Wholesale
Main Service Region : Japan
Product & Service
GMP/GDP compatible temperature mapping service
Service Category :Logistics&Warehouse、Development、Regulation、Modality
SPLine provides Temperature Mapping Services that comply with GMP/GDPAs to support for auditing of pharmaceutical storage facilities
What is Temperature Mapping?
Temperature Mapping is the process of installing temperature loggers at multiple points in a space such as a warehouse or shipping container and analyzing the measured data over a certain period of time. When storing pharmaceuticals, Temperature Mapping is required to measure the temperature distribution within the space in order to comply with GMP/GDP quality control standards and warehouse validation (OQ/PQ).
Temperature has a distribution within a space, but this distribution also increases depending on seasonal changes in temperature, the location of air conditioning equipment, and the opening/closing status of entrance/exit doors. Therefore, it is necessary to understand the temperature distribution characteristics within the space and confirm its suitability.
When analyzing distribution characteristics, it is especially important to understand the worst points (highest and lowest values) from the measured data. The worst point can be used as a reference for determining and evaluating the control values of each warehouse, and for considering the appropriate installation location when installing sensor equipment for constant monitoring.
●GMP (Good Manufacturing Practice)
International standards for manufacturing and quality control of pharmaceutical
products. GMP aims to : (1) minimize human error, (2) prevent contamination and quality changes to pharmaceutical products, (3) guarantee a high level of quality.
●GDP (Good Distribution Practice)
The main points of GDP are : (1) ensuring quality and temperature control, (2) proper management of distribution process,
(3) countermeasures against counterfeit medicines.
Flow of temperature mapping implementation
The temperature logger used for temperature mapping requires NIST (National Institute of Standards and Technology), or a reference device that is the national standard of each country and a three-point calibration that can be traced.
Temperature calibration traceable to AIST is possible.
(1) In the case of Japan, AIST (National Institute of Advanced Industrial Science and Technology)