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Tel: +82-2-3010-1418, Fax: +82-2-3010-6962, [email protected] Copyright 2016 Korean Endocrine Society This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited

The overarching theme is summed up in FDAs longstanding guidance: QUALITY SYSTEMS should be applied to every element of the manufacturing process ( [26] )