Cold Chain Integrity of Drugs

Ms K Thanaletchimi asked the Minister for Health (a) whether the Health Sciences Authority will mandate manufacturers, suppliers and pharmacies to monitor the temperature of pharmaceutical drugs from their source to the patient so as to preserve the cold chain integrity of the drugs; and (b) whether the Ministry provides strict guidelines for suppliers and distributors to observe and include the provision of temperature loggers as evidence of cold chain storage compliance to ensure the potency of their drugs.

The Health Sciences Authority (HSA) requires all drug manufacturers, importers, wholesalers and retail pharmacies to keep their drugs in proper storage conditions, including cold chain storage, under appropriate temperature where necessary. The drugs are also required to be distributed using validated processes to ensure cold chain storage is maintained.

The companies can use different ways to measure and monitor the temperature, such as temperature loggers, or more sophisticated electronic facility management systems.

HSA conducts regular onsite inspections of the premises of the drug manufacturers, importers, wholesalers and retail pharmacies to assure that the regulatory requirements are complied with. During the inspections, HSA checks the raw data captured by the temperature monitoring devices or facility management systems to verify good temperature controls.