Drug officials in Great Britain are concerned that cold chain products are being damaged by temperature and humidity excursions during shipment and storage. The concern extends to both sea and air freight, especially between India and the UK.
Ian Holloway, manager for the UK Defective Medicines Report Centre, told an ISO9001 conference that thermal shock could cause problems at any stage of a cold chain drug's life. He lists a dozen problem areas, including improperly set alarms, inadequate segregation of acceptable and rejected stock, and missing backup power supplies.
Holloway says that trustworthy services and systems for cold chain monitoring, storage and distribution are available. "Validation qualification is a normal Good Manufacturing Practice requirement and there is increasing regulatory interest in moving the entire supply chain nearer to a normal GMP requirement," he says in a trade publication.
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