대한약학회:학술대회논문집 (Proceedings of the PSK Conference)
- 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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- Pages.28-28
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- 2003
International Harmonization of Regulatory Quality Control and Quality Assurance of Drug
초록
After approval, the drug should be manufactured and maintained with uniform quality. To assure the quality of drugs, the drug companies should comply with GMP guidelines and regulatory authorities should assess their compliance. In this article, I want to review the definition of drugs as well as the quality surveillance system. To be controlled as drugs, they ought to have their own specifications and test methods. (omitted)
키워드