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GMP规范对药物制剂生产过程中的产品质量一致程度提出了一定的要求,希望可以保障产品质量具有一致性。在生产药物制剂的过程当中,包含了原料、辅料和包装材料等一系列的物料。这些物料是组成产品的生产工艺的最基本内容,同时也发挥着形成产品质量的基本要素的角色。本文旨在对原材料的选择、验收、存储,包装材料管理以及各个环节过程物料的选择等方面的要求进行阐述,使药物制剂生产中的物料管理能够做到有章可循,并提高供应商在法律、责任、质量等方面的意识,以严格执行药品GMP规范,对药物制剂生产中的物料生产、购买和管理进行严格的规范。
The GMP standard puts forward certain requirements on the consistency of product quality in the process of pharmaceutical preparation production, hoping to ensure the consistency of product quality. In the process of producing pharmaceutical preparations, including raw materials, accessories and packaging materials and a series of materials. These materials constitute the most basic part of the production process of the product and at the same time play the role of the basic element that forms the product quality. The purpose of this paper is to explain the requirements of raw material selection, acceptance, storage, packaging material management and the selection of process materials in all aspects so that material management in pharmaceutical preparation production can be followed, Law, responsibility, quality and other aspects of awareness, to strictly enforce the GMP standard drugs, drug production in the production, purchase and management of materials to strictly regulate.