Ministry of Food and Drug Safety: Guidance on Risk Assessment of Pharmaceutical Additives

The “dangeral evaluation of drug additives” (idance for drug additiveing) has been published with risk measures and systematic management of risk factors, such as the origin, manufacturing process and quality conditions used by drug manufacturers. This library is designed to help improve product quality by raising awareness of the management level of ‘ additives ’ used in medicine and the operation of the drug quality system. In particular, the ICK Commission on Drug Control and Responsibility has reflected foreign - based guidelines for quality management of risk factors (Q9), the European Union’s risk assessment guideline, and the production and quality standards of drug additives (USP). The main points are the risk assessment tool and method additive category and the specific risk management of the additives and the production and quality management criteria. With the aid of anti-Mustical tax offerings (15 different types) and a pre-programming category list, manufacturing and quality evaluation checks against foreign regulations, we have been asked to use them in terms of drug manufacturing and maintenance. The risk assessment of additives used in medicine and the understanding of manufacturing and quality management will help drug manufacturers to produce safe medicine.

Korean title: 의약품 첨가제 위험평가 가이던스

Korean author: 식품의약품안전처

Korean publisher: 진한엠앤비

ISBN-13: 9791129001917