International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Removed by Editorial Board

2. Emerging Concern of the Impact of Temperature Excursions on the Quality of Medicines Along the Supply Chain in Malaysia
Mathews A, Dash Gouri Kumar
Abstract
The pertinent quality assurance question to be addressed within the pharmaceutical supply chain starting from the finished product in a manufacturing facility to the time a patient receives the medicine, is how much of the potency has been lost due to the effect of temperature excursions.   The product may be shipped (by sea, land or air) to various storage distributor facilities within the country. The distributor then may supply directly or indirectly via wholesalers to clinics, pharmacies and hospitals. Most non-cold chain medicines would need a storage temperature of below 25°C but day-time temperatures in Malaysia exceed this temperature throughout the day. Although temperatures in main storage facilities are monitored and documented, concerns arise during shipments in non-air-conditioned metal containers across sea channels which can last weeks and temperatures are expected to soar.  The official pharmacopoeias note the need for caution when medicines are exposed to temperature excursions.  There is a need for research to be carried out to determine the extent of degradation of medicines along the supply chain.

 

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