Guidelines and strategy of the International Conference of Harmonization (ICH) and its member states to overcome existing impurity control problems for antibiotics in China.

Abstract:

:In the present report, we review the technical guidelines and principles on impurity research and control for antibiotics established by various agencies, including the International Conference of Harmonization (ICH), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the China Food and Drug Administration (CFDA). Progresses with the US Pharmacopoeia (USP), the European Pharmacopoeia (EP) and the Chinese Pharmacopoeia (ChP) to control impurities in antibiotics are also presented. Next, our discussion is focused on analyzing the CFDA's requirements on impurity research and control for antibiotics, and the implementation of ICH, FDA and other technical guidelines for generic drugs impurity control in China. Existing problems are further reviewed, in order to improve the overall process for the control of antibiotic purity.

journal_name

Chin J Nat Med

authors

Jiang Y,Xia JP,Yang JH,Zhang ZF,Hu CQ,Zhang ZR

doi

10.1016/S1875-5364(15)30044-3

subject

Has Abstract

pub_date

2015-07-01 00:00:00

pages

498-506

issue

7

eissn

2095-6975

issn

1875-5364

pii

S1875-5364(15)30044-3

journal_volume

13

pub_type

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