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Ensure the quality of your thermolabile drugs

Updated: Nov 4, 2021

Address regulatory demands, avoid losses and ensure customer satisfaction

With the release of RDC 430, published by Anvisa in March of this year, drug distributors have a deadline to implement temperature and humidity monitoring throughout the distribution chain: in storage, transport and retail (pharmacies and clinics).

In the future, electronic monitoring will likely be mandatory for pharmacy, hospital and clinic chains.

Best practices recommended by Anvisa

Anvisa recommends some good practices in its RDCs (304/2019 and 430/2020):

  • Storage and transportation locations for thermolabiles must have equipment and instruments for continuous monitoring of temperature and humidity in their facilities;

  • Adoption of refrigerated areas next to the spaces where products are received and shipped, reducing the exposure of thermolabile drugs at room temperature;

  • Thermolabile drugs must be stored as recommended by the registration holder in a thermally qualifying medium;

  • Ensure alternative energy sources for the equipment that will store thermolabile drugs;

  • Preferential use of computerized temperature monitoring systems;

  • Enable the tracking of drugs, batch number, date and time of start and end of monitoring in devices used to monitor temperature and humidity, in addition to having alarms that signal variations outside the valid ranges.

Care in the storage of drugs is essential to ensure their integrity and effectiveness, as well as the safety of the patient who will use the substance. In the case of thermolabile drugs, this care must be redoubled, requiring constant temperature monitoring throughout the cold chain.

In the future, electronic monitoring will likely be mandatory for pharmacy, hospital and clinic chains.

Are your pharmacies prepared for this new stage? Its process ensures that there will be no temperature fluctuations in storage by exposing the thermolabiles to room temperature for long periods?

Ayga launched on the market in 2021 the Ayga Pharma solution, a complete solution that ensures temperature and humidity monitoring at all stages of the thermolabile drug distribution process, ensuring data recording and storage and generating alarms in case of failures in the refrigeration systems.

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