MFDS 소식

「실험동물에 관한 법률 시행령」일부개정령(안) 입법예고 알림

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「의약품 등의 안전에 관한 규칙」 일부개정령(안) 입법예고 알림

식품의약품안전처 공고 제2018-028호

「의약품 등의 안전에 관한 규칙」을 개정하는 데에 있어, 그 개정이유와 주요내용을 국민에게 미리 알려 이에 대한 의견을 듣기 위하여 ｢행정절차법｣ 제41조에 따라 다음과 같이 공고합니다.

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GMP 가이드라인

Possible Dioxin/PCB Contamination of Drug and Biological Products

This guidance is intended for manufacturers using materials derived from animal sources
in the manufacture of human or animal drugs or biological products. During the period
from January through June 1999, some poultry, swine, and ruminants (cattle, sheep, and
goats) in several EU (European Union) countries were fed feed contaminated with
dioxins and PCBs (polychlorinated biphenyls).

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In the manufacture of the sterile bulk powders, it is important to recognize that there is no further processing of the finished sterile bulk powder to remove contaminants or impurities such as particulates, endotoxins and degradants.

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