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药品生产质量管理规范(GMP),通常划分为硬件和软件两部分,现就实施软件的工作试论如下。一、中成药生产的主要工艺技术标准: 企业建立完整的质量标准所包括内容如下。 (一)药品标准(成品标准):药品标准是质量标准的主体,其它质量标准暂称为药品标准相配套的标准,以突出药品标准的主要地位。药品标准应包括以下三部分:法定标准:包括《中华人民共和国
The GMP standard for pharmaceutical production is usually divided into two parts: hardware and software. The following is a discussion on the implementation of software. I. The main technical standards for the production of proprietary Chinese medicines: The establishment of complete quality standards for enterprises includes the following. (I) Drug standards (finished product standards): Drug standards are the main body of quality standards, and other quality standards are tentatively called standards for pharmaceutical standards to highlight the main status of drug standards. Drug standards should include the following three parts: Statutory standards: Including the People’s Republic of China