Introduction to Annex 9.
The WHO created a guideline to help companies develop better Good Distribution Practices (GDP). This article summarises Supplement 15: “Temperature and Humidity Monitoring Systems for Transport Operations”, but other supplements include:
WHO Annex 9 Supplement 15: Temperature and Humidity Monitoring Systems for Transport Operations
This article summaries WHO’s Supplement 15 regarding temperature and humidity monitoring for transport operations.
Every product has a different temperature or humidity requirement in which the product must be maintained within. Exposing a product to temperatures or humidity outside the specification can affect the products strength, efficacy and potency.
For quality assurance purposes, documented evidence must be available to prove the product has not been exposed to temperatures out of specification during transport. Effective temperature and humidity monitoring are an important component of Good Distribution Practice (GDP).
Other Technical Supplements to consult are:
- Qualification of temperature-controlled road vehicles
- Qualification of shipping containers
- Transport route profiling qualification
- Temperature-controlled transport operations
- Temperature and humidity monitoring systems for fixed storage areas.
It is ultimately the responsibility of the sender (shipper) of the product to maintain product compliance during shipping. In order to assist in this, formal service level agreements (SLA) should be in place with the transport company (freight forwarders, 3PL, 4PL etc). The SLA should stipulate the required transport temperature and/or humidity specification. The SLA should also stipulate how and what temperature monitoring devices will be used, how the data will be collected, reported and stored. Standard operating procedures can be of assistance (SOP).
The purpose of this Supplement 15 is to;
- Identify devices used to record temperature and humidity
- Identify the required documented evidence that should be supplied to regulatory authorities, Quality assurance and interested parties.
Active or passive shipping systems can be used to maintain temperature. There are a number of factors to consider when choosing a suitable temperature monitoring device.
Temperature and Humidity Monitoring Devices:
The purpose of a temperature and humidity monitoring device is to determine whether or not the pharmaceutical product has been compromised as a result of exposure to unfavored conditions. The customers URS will specify the type of device that should be used during shipments. Any device used in shipment, must meet regulatory requirements. A single use device must be within the manufactures calibration and multi-use devices must be calibrated against a traceable reference standard once a year.
Consideration must be given to how the device will be integrated across the supply chain. It must be accurate, stable, reliable and validated. All locations must be able to download and provide data if required.
There are numerous temperature and humidity devices that are commonly used as temperature monitoring devices.
- Chemical indicators (CI) including threshold and progressive and time. (CTTI)
- Electronic Temperature Indicators (ETI)
- Electronic Data Logger Monitors (EDLM)
- Electronic Data Integrators (EDI)
- Electronic temperature monitoring and event logger for refrigerated vehicles (TMEL)
Each device has different specifications and accuracy and therefore should be carefully considered to meet the required URS.
Data Collection, Storage and Retrieval
Each device reports data information differently. Devices such as Chemical Indicators do not provide electronic files therefore the information must be captured on the product arrival documentation. Electronic data logger monitors can be downloaded and provide information electronically and therefore should be stored in a suitable format such as hard copies, electronic medium such as flash drive, web-based data repository etc. Typically, electronic information should be retained for a minimum of 3 years.
If this article is of interest you can read the full Supplement here: World Health Organization, 2014, “Temperature and Humidity monitoring systems for transport operations Annex 9, Supplement 15. Switzerland.
CoolPac supplies temperature data loggers, humidity data loggers and wireless monitoring systems to the pharmaceutical and Life Science Industries.