Korea Food and Drug Administration, Food and Drug Safety Evaluation Institute: Q&A on Guidelines for Managing Changes in Manufacturing Methods After Drug Approval
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From South Korea
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Description
This standard is aimed at ‘unspecifying the demands of the quality management system which the medical manufacturers must apply to all manufacturing and quality management processes, from the wear of raw materials to the release of finished products.’.
Korean title: 의약품 허가 후 제조방법 변경관리 가이드라인 질의응답집
Korean author: 식품의약품안전처 식품의약품안전평가원
Korean publisher: 진한엠앤비
ISBN-13: 9791129051615
식품의약품안전처 식품의약품안전평가원: 의약품 허가 후 제조방법 변경관리 가이드라인 질의응답집
식품의약품안전처 식품의약품안전평가원: 의약품 허가 후 제조방법 변경관리 가이드라인 질의응답집
