• What do we need to do to ensure compliance with the HPRA/EU GDP Guidelines on temperature for storage and transport of medicinal product?
• Why do we need Temperature Mapping?
• How do I choose the right Temperature Monitoring System?
• Why do we need Calibration? What are HPRA requirements for Calibration?
• How do I manage Calibrations?

What do we need to do to ensure compliance with the HPRA/EU GDP Guidelines on temperature for storage and transport of medicinal product and blood packs?

To comply with these guidelines you are required to have the relevant Quality Management System in place ; to have temperature mapping studies performed and to have a calibrated continuous temperature monitoring system installed.

Why do we need Temperature Mapping?

For many medicinal products, storage and transportation temperatures are a highly significant factor in maintaining the quality of medicinal products throughout the distribution network’’ (HPRA Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances). A temperature mapping study is performed to generate a temperature profile of your facility/equipment to ensure that it is capable of maintaining the required product storage temperatures and to determine the placement of the continuous monitoring sensors.

• ‘’Medicinal products should be transported in such a way that they are not subjected to unacceptable degrees of heat and cold’’ (Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products, John Taylor CChem, FRSC, MHRA Inspector). Regulatory Guidelines
• ‘’32% of all critical and major deficiencies recorded by MHRA’s GDP inspectors during 2005/2006 related to the control and monitoring of storage and transportation temperatures’’ (Cold Chain Distribution for Pharmaceuticals, Cheryl Blake January 2008)

What is involved in a Temperature Mapping Study?

Following initial contact Rototherm will arrange a site visit to perform a site survey and risk assessment. This provides the necessary data for the production of a quotation for the work.

On receipt of your instructions to perform the temperature mapping study the process is as follows:

• Rototherm prepare a project plan for the temperature mapping and timelines are agreed
• Rototherm prepare the Protocol for the Temperature Mapping which is agreed and signed off by both parties prior to the start of the mapping study
• Temperature Data Loggers are placed in your facility in accordance with the Protocol by Rototherm trained Technicians with height assistance, if required, provided by you. These data loggers are left in place for the duration of the mapping study
• At the end of the mapping study Rototherm Technicians retrieve the data loggers and bring back to Rototherm for data download, analysis and report creation.
• The Mapping Report, when finalised to the agreed timelines, is reviewed with the customer to ensure understanding o f the process and the report including all recommendations.

How do I choose the right Temperature Monitoring System?

Each customer’s requirements are unique. Rototherm can help you choose the best monitoring system for your business, giving due consideration to factors such as reliability, mobility, cost, accuracy, precision, 21 CFR Part 11 compliance.
We have a broad suite of monitoring system options, ranging from the fully 21 CFR Part 11 compliant IceSpy System to the robust mobile Thermadata logger. Key Products

Why do we need Calibration? What are HPRA requirements for Calibration?

Temperature Sensors [probes; data loggers] require regular calibration to ensure that they are still operating within their stated accuracy specification. The HPRA requires that all sensors are calibrated annually at three temperature points across the temperature range that they are being used at.

How do I manage Calibrations?

Rototherm will remind you when your equipment is due for calibration. Simply send your temperature/ humidity loggers and meters in to Rototherm and we will take it from there.

Alternatively, we can carry out calibrations on site Calibrations are all traceable to National Standards and carried out, as standard, on three points over their usage scale. When performing on-site calibration Rototherm now offers as standard a premium service to fully comply with recently revised HPRA guidelines. This involves  providing replacement sensors to ensure continuous monitoring of all locations during the calibration period and a full report covering all required aspects of the revised guidelines.