Ministry of Food and Drug Safety: Guidance on Manufacturing and Quality Control Standards for Active Pharmaceutical Ingredients (2020)

The process of making and managing raw materials is designed to determine the basis for the manufacture of medicine and quality management standards for the production of them under proper systems to manage them. It also uses a guarantee that raw drugs will be suitable for the needs of quality and purity that should be set or equipped. In this library the 'producing' includes all the work of wearing, manufacturing, packaging, repackaging, marking, remarking, quality management, release, storage, distribution and related management of raw materials. The gas does not set up a prescription for medical and pre-suppression of raw medicines or use an impartially required correction. The information on the drug policy (reported) and the source’s registration card must be observed.

Korean title: 원료의약품 제조 및 품질관리기준 가이던스(2020)

Korean author: 식품의약품안전처

Korean publisher: 진한엠앤비

ISBN-13: 9791129015440