制备过程应当严格执行《药品生产质量管理规范》的要求。
The preparing process shall strictly follow the Criterions for the Quality Control of Drug Manufacturing.
通过《药品生产质量管理规范》认证，是国家对制药企业的法规性要求。
It is a legal requirement of the state for pharmaceutical enterprises to qualify GMP authentication.
前言：目的：药品生产企业一切生产活动应以《药品生产质量管理规范》文件为根据。
Objective: All productive activities in pharmaceutical corporation should be based on documents on GMP.
第三十二条临床研究用药物，应当在符合《药品生产质量管理规范》条件的车间制备。
Article 32 Drugs for use in clinical study shall be prepared in workshops meeting the conditions provided for in the Criterions for the Quality Control of Drug Manufacturing.
食品及药物管理局宣布了针对人类血液和血液组分的采集，加工和存储的药品生产质量管理规范(GMP)。
The FDA declares Good Manufacturing Practices (GMP) for the collection, processing, and storage of human Blood and Blood components.
负责药品、医疗器械行政监督和技术监督，负责制定药品和医疗器械研制、生产、流通、使用方面的质量管理规范并监督实施。
To formulate and revise norms for the quality management of drug research, manufacturing, distribution and use, and supervise their implementation.
第二条本规范是药品生产和质量管理的基本准则。
Article 2: This Regulation is promulgated as the basic guideline for manufacturing and quality control of pharmaceutical products.
第二条本规范是药品生产和质量管理的基本准则。
Article 2: This Regulation is promulgated as the basic guideline for manufacturing and quality control of pharmaceutical products.
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