A drug safety safety expert has warned nearly 70 medical experts at an educational study day of regulators’ increasing concern that cold chain pharmaceutical products are being damaged by unacceptable temperatures and humidity during shipment or storage.
Ian Holloway, Medicines & Healthcare Product Regulatory Agency manager of the UK Defective Medicines Report Centre, expressed concern that thermal shock could influence degradation of kinetics and cause problems at any stage of their shelf life, and said people needed to be aware that specialised blue chip services and systems for monitoring, storage, and distribution, were becoming increasingly available. The speaker, who manages the Defect Centre that advises companies on defective products and handles product recalls, was speaking at an educational study day staged by building energy management system supplier, Next Control Systems, which has developed its Tutela monitoring service for the medical sector. Fully compliant with NHS N3 network access, it automatically records temperature, humidity, and other data, and stores it electronically for up to 30 years. A fully manned, 24/7 alarm monitoring service notifies customers when equipment malfunctions. Ian Holloway listed twelve major problem areas with cold rooms, ranging from alarms set to wrong values after maintenance, and mould on walls, to inadequate segregation of acceptable and rejected stock, and dirty fan units and blades.
