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第一条 为规范药品生产质量管理,根据《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》,制定本规范。Article 1. This regulation is enacted to regulate the standards of Pharmaceutical Manufacturing and Quality Management in accordance with the “Drug Administration Law of the People’s Republic of China” and “Regulations for Implementation of Drug Administration Law of the People’s Republic of China”.