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CONTAINMENT & CLEANROOMS
THE VITAL ROLE OF TEMPERATURE MONITORING IN THE PHARMA COLD CHAIN
T
he rollout of COVID-19 vaccines has highlighted the importance of temperature monitoring and control in the pharmaceutical supply chain, whilst also raising awareness and understanding of the different temperature requirements of products. This article from global measurement technology provider Vaisala will discuss the challenges and describe solutions for both static and dynamic temperature monitoring. BACKGROUND Pharmaceutical manufacturers must qualify temperaturecontrolled storage areas and provide evidence of continuous temperature monitoring in storage areas to regulatory agencies and clients. Temperature mapping, refrigeration equipment maintenance, and the calibration of sensors are also necessary. Following manufacture, pharmaceutical products generally reach end users through a complex cold chain with multiple stages. It is therefore vital that each stage is monitored accurately and reliably. All parties within the cold chain seek the successful delivery of the product, without harming its quality or integrity. A continuous temperature monitoring system should therefore provide all parties with the information they need. Regulations are generally created by national regulatory agencies, other regulatory bodies such as IATA and the ICH, while international
organisations such as the WHO create guidelines. Regulatory pressures are strongest at the manufacturer’s end of the supply chain, with comprehensive temperature monitoring being undertaken by drug manufacturers and documented in quality agreements with their downstream supply chain partners. Examples of national regulatory agencies include the USFDA, the European Medicines Agency and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. These organisations issue guidelines such as the MHRA publication ‘Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017’ which provides detailed requirements for the calibrated accuracy of temperature monitoring.
The cost of highquality sensors is negligible in comparison with the value of the assets and goods that they protect.
TEMPERATURE CONTROL REGULATIONS The USFDA’s Federal Food, Drug, and Cosmetic Act states that a drug is adulterated if the facilities or controls used for its ‘manufacture, processing, packing or holding’ do not conform with Current Good Manufacturing Practice (cGMP). The term ‘holding’ refers to any way in which a drug is ‘distributed, transported, or warehoused for distribution or transfer.’ Maintaining temperature control is a GMP requirement; if goods are not maintained in specified conditions throughout all stages, they are considered adulterated. The ICH Q9 ‘Guideline on Good Manufacturing Practices (GMP)’ also requires that manufacturers ensure the transporters of products follow appropriate transport and storage conditions.
