T/CNPPA 3008-2020 in English

本标准规定了空心胶囊的性状、规格和品种、技术要求、检测方法、检验规则、判定规则、包装、标识、运输和贮存。
本标准适用于空心胶囊规格尺寸和外观质量的相关要求。

Scope

The quality assurance of hollow capsules comes from the quality control of the entire process, including the raw materials used, production technology, production environment, batch division, packaging, storage, transportation and other factors and links that affect product quality, all of which should comply with the corresponding technical specifications. This standard applies to the relevant requirements for the specifications, dimensions and appearance quality of hollow capsules. In addition to complying with the relevant technical requirements of this standard, the quality of hollow capsules should also comply with relevant national and association regulations such as the "Good Manufacturing Practice for Pharmaceutical Excipients", "Pharmacopoeia of the People's Republic of China", "General Requirements for Hollow Capsules", etc. to ensure the quality of hollow capsules. and safety.