摘要：
国家十四五规划提出，提高食品药品等关系人民健康产品和服务的安全保障水平。药品质量安全是关乎民生的大事，制剂产品的质量直接影响到用药者的人身安全和药品疗效。随着人类对药品中异物危害的认识的提高和药典的逐步发展完善，制剂产品的质量越来越受到全社会的重视。原料药API作为制剂中的有效成分，其质量好坏直接影响到制剂相关产品的质量。化学原料药的生产大多工艺比较复杂，生产线较长，大生产中用到的各类设备较多，生产过程控制复杂，而且精细操作要求高。客观上讲，黑点异物是不可能完全杜绝的，那么有效控制就成为提高产品质量的关键。目前各国药政机构或药典对成品原料药中黑点异物的明确要求是非常有限的，所以黑点异物的控制问题一直困扰着许多药品生产和质量人员。本文就化学原料药API生产过程中，洁净区黑点异物的问题进行系统分析，并给出一些切实有效的控制措施，从而为化学原料药API的生产质量安全提供保证。
Abstract
According to the 14th Five-year Plan of the People's Republic of China, the safety level of will be improved, which are food, drugs and other products and services related to people's health. Drug quality and safety is an important issue related to people's livelihood. The quality of medical preparations directly affects the safety and efficacy of drug users. With the human awareness improvement of the foreign particles harm in drugs and the gradual development and perfection of pharmacopoeia, the quality requirements of preparation products are higher and higher. As the active ingredient in the preparation, the quality of Active Pharmaceutical Ingredient (API) is directly related to the quality of the preparation product. However, the process of chemical API is mostly complicated, and the production routine is always very long, with many kinds of equipment used in scale-up production, many control points in the production process, and high requirements for fine operation control. Objectively, the black particles can not be removed totally, then effective control becomes the key to improve product quality. At present, there are very limited clear requirements for black particles in finished drug by drug administration organizations or pharmacopoeia, so many drug production and quality people has been perplexed by the control of black particles. In this paper, the problem of black particles in the production cleaning area of chemical API is systematically analyzed, and some effective control measures are shared. So as to ensure the production quality and safety of chemical API.
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