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Pharmaceutical Storage


The domestic pharmaceutical industry has faced daunting international challenges in the wake of Taiwan's accession to the WTO. In order to enhance the quality of Taiwan-made pharmaceuticals, the Food and Drug Administration, Department of Health has required all domestic pharmaceutical companies to pass the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme GMP (PIC/S GMP) standards by the end of 2014. Any companies that fail to do so will be barred from manufacturing and selling drugs, and will no longer be issued (or re-issued) pharmaceutical certificates.

 

Because pharmaceuticals have special attributes (such as temperature requirements and drug controls) that constitute an extension of medicine in general, they have stricter quality control requirements than most cargo in ordinary logistics. In order to meet the requirements of PIC/S GMP, and ensure stable quality throughout the storage and distribution process, it is necessary to faithfully record and manage information such as drugs' validity periods, lot numbers, sales recipients, dates, and quantities in order to facilitate tracking. With regard to sales requirements, both "first in first out" and "first expiration first out" schemes have strict rules.

 

Pharmaceutical firms have had to make great investments in order to comply with PIC/S GMP standards. In view of the fact steadily rising pharmaceutical production costs and continuously dropping health insurance drug reimbursements, the upstream domestic pharmaceutical industry, which includes pharmaceutical firms and agents, has mostly had to outsource pharmaceutical logistics (distribution and storage), and let third-party pharmaceutical logistics firms handle the "last mile" of their pharmaceutical supply chains. Pharmaceutical firms have been able to comply with the PIC/S GMP by ensuring product quality at reasonable cost in this way.