The Growth Of Biopharmaceutical Molecules Essay

727 Words Nov 16th, 2015 3 Pages
Regulators have presented pharmaceutical companies with a multitude of distribution challenges to navigate when supplying and transporting cold chain therapeutic medicines such as biomolecules. The growth of biopharmaceutical molecules has created a heightened awareness from regulating agencies, which have therefore created a substantial growth in the amount of regulatory and industry guidance documents. The influx of new industry documents as well as regulations, has presented pharmaceutical companies numerous obstacles to navigate while planning their supply chains in order to maintain compliance, create value and effectively manage the associated costs. There have been several organizations in the United States as well as world-wide, that have provided guidance documents and appropriate legislation related to pharmaceutical cold chain supply in order to ensure the quality of the medicines remain unaffected during the transportation process due to temperature excursion, tampering or adulteration.
The World Health Organization (WHO) has created documentation such as QAS/04.068, to describe that Good Distribution Practices (GDP) are applicable to all persons and companies involved in the distribution of pharmaceutical products including; manufacturers of intermediate and/or finished products, brokers, suppliers, distributors, wholesalers, traders, transport companies, forwarding agents and processors. The aim of the WHO document QAS/04.068 primarily attempts to…

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