11.120.99 有关制药学的其他标准 标准查询与下载

T/XZYC 0003-2021 山银花采收与产地初加工技术规范

1  范围 2  规范性引用文件 3  术语和定义 3.1 山银花 Lonicerae Flos 3.2  产地初加工 Primary processing 3.3  二白期 Cyan and white period 3.4  大白期 White period 4　技术要求 4.1　采收时间 4.2　采收方法 4.3　杀青 4.4　除杂 4.5　干燥 4.6　质量要求 5　包装、标识和仓储 5.1　包装 5.2　标识 5.3　仓储 6　档案管理 6.1　资料记录 6.2　资料管理

Technical specifications for harvesting and primary processing of Lonicerae Flos

T/XZYC 0002-2021 黄精采收与产地初加工技术规范

1  范围 2  规范性引用文件 3  术语和定义 3.1 黄精Polygonati Rhizoma 3.2 产地初加工 Primary processing 4 技术要求 4.1　采收时间 4.2　采收方法 4.3　鲜品存放 4.4　挑选、除杂 4.5　洗净 4.6　预处理 4.7　干燥 4.8　质量要求 5　分级、包装、标识和仓储 5.1　分级 5.2　包装 5.3　标识 5.4　仓储 6　档案管理 6.1　资料记录 6.2　资料管理

Technical specifications for harvesting and primary processing of Polygonati Rhizoma

T/XZYC 0005-2021 枳壳枳实采收与产地初加工技术规范

1  范围 2  规范性引用文件 3  术语和定义 3.1 枳壳 Aurantii Fructus 3.2  枳实 Aurantii Fructus Immaturus 3.3  产地初加工 Primary processing 3.4  切瓣 Cutting 4　技术要求 4.1　采收时间 4.2　采收方法 4.3　鲜果保存 4.4　产地初加工 4.5　质量要求 5　分级、包装、标识和仓储 5.1　分级 5.2　包装 5.3　标识 5.4　仓储 6　档案管理 6.1　资料记录 6.2　资料管理

Technical specifications for harvesting and primary processing of Aurantii Fructus and Aurantii Fructus Immaturus

T/XZYC 0001-2021 博落回果叶采收与产地初加工技术规范

1  范围 2  规范性引用文件 3  术语和定义 3.1 博落回果 Fructus of Macleaya cordata (Willd.) R.Br. 3.2  博落回叶Folium of Macleaya cordata (Willd.) R.Br. 3.3  产地初加工 Primary processing 4 技术要求 4.1　采收时间 4.2　采收方法 4.3　干燥 4.3.1　晒干 4.3.2　烘干 4.4　后处理 4.4.1　除杂 4.4.2　粉碎 5　包装、标识、仓储 5.1.1　包装 5.1.2　标识 5.1.3　仓储 6　档案管理 6.1　资料记录 6.2　资料管理

Technical specifications for harvesting and primary processing of Macleayae Cordatae Fructus and Macleeayae Cordatae Folium

T/XZYC 0004-2021 吴茱萸采收与产地初加工技术规范

1  范围 2  规范性引用文件 3  术语和定义 3.1 吴茱萸Euodiae Fructus 3.2  产地初加工 Primary processing 4　技术要求 4.1　采收时间 4.2　采收方法 4.3　鲜果保存 4.4　干燥 4.4.1　烘干 4.4.2　晒干 4.5　脱粒除杂 4.6　质量要求 5　包装、标识和仓储 5.1　包装 5.2　标识 5.3　仓储 6　档案管理 6.1　资料记录 6.2　资料管理

Technical specifications for harvesting and primary processing of Euodiae Fructus

DB34/T 3809-2021 中药材加工技术规程 虎杖

Chinese herbal medicine processing technical regulations Polygonum cuspidatum

T/ZAPA 0001-2021 《医药洁净厂房运行维护技术规范》

医药洁净厂房运行维护技术规范 本标准规定了医药洁净厂房运行维护的一般要求、术语和定义、生产区域的日常维护、设备的运行与维护及检测技术要求。 本标准适用于医药洁净厂房及相关企业的生产运行维护。

TECHNICAL SPECIFICATION FOR OPERATION AND MAINTENANCE OF PHARMACEUTICAL CLEAN WORKSHOP

LST EN ISO 21976:2020 包装 医药产品包装的篡改验证功能（ISO 21976:2018）

Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018)

DB41/T 2022-2020 地理标志产品 汤阴北艾

Geographical indication product Tangyin Beiai

KS P ISO 11418-4:2020 药物制剂的容器和附件 - 第4部分:平板玻璃瓶

Containers and accessories for pharmaceutical preparations —Part 4: Tablet glass bottles

KS P 2080-2020 煎煮草药制剂标识指南

Guidelines for labelling to identify decocted herbal medicinal preparations

KS P ISO 11418-4-2020 药物制剂的容器和附件 - 第4部分:平板玻璃瓶

Containers and accessories for pharmaceutical preparations —Part 4: Tablet glass bottles

DB1308/T 281-2020 热河黄芩道地药材加工技术规程

本文件适用于热河黄芩道地药材的产地初加工

Rehe Scutellaria baicalensis Authentic Medicinal Materials Processing Technical Regulations

DIN EN ISO 21976:2020 包装. 医药产品包装的篡改验证功能(ISO 21976-2018); 德文版本EN ISO 21976-2020

This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products. The principles in this document can be applied in other sectors, as appropriate.

Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018); German version EN ISO 21976:2020

T/JNPIA 001-2020 九蒸九晒酒黄精炮制规范

本文件规定了九蒸九晒酒黄精炮制的一般规定和炮制工艺。

Nine-steamed and nine-dried wine Polygonatum

T/GDPA 1-2020 医疗机构3D打印药品分剂量片技术规程

3D打印医院药品分剂量是通过计算机设计数字模型，对市售药品粉末再成型，精准控制每一片分剂量的药物含量。具体的步骤是根据需要药品分剂量的医嘱将市售药品、药用辅料置于粉碎设备中充分研细，制成适宜3D打印粘稠度的药浆。将装有药浆的料筒安装至3D打印机上，启动3D打印机，进入电脑操作软件界面，根据需求设置模型形状及相关参数，调节3D打印机的挤出气压，开始打印分剂量药片。经过外观，片重检查等质量检查后，合格的3D打印分剂量片贮存于贴有标签的棕色瓶中，标签内容包含：药品名称、调剂日期、规格等，供药师根据医嘱发给患者使用。

Technical Specification of 3D Printing Subdivided Tablets in Medical Institutions

ASTM D8334/D8334M-20 实验室分析用大麻/大麻收获后批次取样的标准实施规程

1.1 Cannabis harvested materials require sampling strategies throughout their life cycle, from cultivation to the end consumer. For purposes of this standard, the term cannabis is inclusive of all cannabis inflorescence, including hemp varieties. The qualitative and quantitative characteristics of cannabis/ hemp for human or animal consumption has safety implications throughout the life cycle from cultivation to end consumer. This standard provides best practice procedures and protocols for sampling batches of harvested cannabis inflorescence. Cannabis/hemp materials often exhibit variability across different parts within the same plant or across different plants within the same cultivar, or both, (1, 2).2 Thus, sampling strategies are required which yield a representative a sample across a harvest batch. Representative sampling is required to ensure that the qualitative and quantitative test results accurately reflect cannabinoid identification, potency, identification and concentration of terpenes, concentration of trace metals, microbiological activity, mycotoxins, and concentration of pesticides across the batch. 1.2 Where procedural aspects of this practice differ from local regulatory or jurisdictional requirements, the local regulatory or jurisdictional authority’s directives shall take precedence. 1.3 Units—The values stated in either SI units or inchpound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Practice for Sampling of Cannabis/Hemp Post-Harvest Batches for Laboratory Analyses

DS/ISO 21976:2020 包装 医药产品包装的篡改验证功能

Packaging – Tamper verification features for medicinal product packaging

DS/EN ISO 21976:2020 包装 医药产品包装的篡改验证功能（ISO 21976:2018）

Packaging – Tamper verification features for medicinal product packaging (ISO 21976:2018)

EN ISO 21976:2020 包装 - 医药产品包装的篡改验证功能

This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018)