工厂药品生产与质量控制过程研究——以达鲁帕什托利德为例

M. Torkashvand, A. Hasan-Zadeh
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引用次数: 0

摘要

Tolid Mavade Avallieh Daroupakhsh公司是中东地区最大的药用活性药物成分生产商,也是全球麻醉品和非麻醉品生产领域的知名公司之一。除了生产,这个综合体也没有忽视环境问题。在这方面,多年来,环保一直被严肃地提上日程,自2007年以来,随着独立单位“生产支持单位”的成立,环保工作更加认真地走上了这条道路。药品制造商的首要任务是确保其产品的安全性和有效性。只有在持续的质量控制方法的情况下,它才是重要的。为此公司设有管理、会计、行政商务、计划经理、技术经理、洗衣房、仓库经理、控制实验室、生产控制、合成、配方、生产管理、生产经理、包装、涂料、设施、仓库技术管理、包装和原料药等部门。化学家对活性药物成分和药品质量的测试在受控实验室进行。其他任务包括质量控制和保证以及控制方法的开发,以确保生产过程与良好的GMP生产操作相匹配。在新药房,该部门的另一项任务是确保生物研究和临床试验具有良好的实验室操作GLP和良好的临床操作GCP的兼容性。例如,这些操作将由质量控制和保证部门控制,并确认其符合GCP, GMP, GLP。本文对这些案例进行了详细的讨论。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Study of Drug Production and Quality Control Process in Factories: A Case Study in Tolid Mavade Avallieh Daroupakhsh
Tolid Mavade Avallieh Daroupakhsh Company is known as the largest producer of pharmaceutical active pharmaceutical ingredients in the Middle East and as one of the reputable companies in the field of production of narcotic and non-narcotic products worldwide.In addition to production, this complex has not neglected to consider environmental issues. In this regard, for many years, environmental protection has been seriously on its agenda, and since 2007, with the formation of an independent unit called "Production Support Unit" has followed this path more seriously. The first task of pharmaceutical manufacturers is to ensure the safety and effectiveness of their products. It is important only in the case of continuous quality control methods. For this reason the company has various departments including management, accounting, administrative and commercial affairs, planning manager, technical manager, laundry, warehouse manager, control laboratory, production control, synthesis, formulation, production management, production manager, packaging, coating, Facilities, technical management of warehouse, packaging and active pharmaceutical ingredients. Tests performed by a chemist on active pharmaceutical ingredients and drug quality are performed in a controlled laboratory. Other tasks include quality control and assurance and the development of control methods to ensure and match the production process with good GMP production operations. In the new pharmacy, another task is the responsibility of this department, and that is to ensure the compatibility of biological studies and clinical tests with good laboratory operations GLP and good clinical operations GCP. For example, these operations will be controlled by the quality control and assurance department, and their compliance with GCP, GMP, GLP is confirmed. All of these cases are discussed in detail in this paper.
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