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Using Technological Advances to Simplify Cold Chain Monitoring Procedures

Using Technological Advances to Simplify Cold Chain Monitoring ProceduresWith pharmaceutical manufacturers and distributors having to meet the challenges and expense of cold chain distribution under increasingly stringent and far reaching regulations, it's not surprising that there's so much attention being given to the topic within the industry. And yet the Medicines and Healthcare Products Regulatory Agency (MHRA) continues to report worrying figures - 52 per cent of all critical and major deficiencies recorded by the MHRA's good distributions practice (GDP) inspectors during 2002/2003 related to the control and monitoring of storage and transportation temperatures. This represents an increase of 18 per cent over 2001/2002 figures. So where is the industry going wrong? Part of the problem seems to be industry guidance, or rather the lack thereof. While the pharmaceutical industry is well regulated and legislated, in this area at least there is a lack of accepted methodology; we know we need to comply with certain regulations, but how do we go about doing it?

The Case for Routine Temperature Monitoring

Already a sea-change can be seen with the widespread adoption of routine shipment monitoring. To date, many manufacturers or distributors have validated their distribution chain but stopped short of measuring the temperature of each shipment. Why bother? While validation of the cold chain is required, it does not in itself guarantee compliant shipments, as there is no verification that parameters remain within the validated limits.

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By Natalie Roy, Product Manager, and James Wilson, Technical Director at Gemini Data Loggers (UK) Ltd

Natalie Roy is a Product Manager at Gemini Data Loggers (UK) Ltd. With over eight years' experience in temperature monitoring and data acquisition systems, she has spent many years with Eurotherm in both the Europe and the US, becoming Data Acquisition Product Manager and principle in-house trainer on 21 CFR Part 11 and GAMP for the Americas. Natalie has an MEng in Chemical Engineering from Imperial College and has also studied at the Ecole Nationale Supérieure d'Ingénieurs de Génie Chimique in France.

James Wilson holds an MEng in Electronic Engineering and had been working as an Electronic Design Consultant for a number of years when he first came into contact with Gemini. Specialising in temperature measurement and data acquisition, James joined forces with Gemini's research and development team 10 years ago and is now Technical Director for the Gemini group.

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Natalie Roy
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James Wilson
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