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In spring 2018, the United States Pharmacopeia (USP) announced plans to revise general chapters <795> and <797>, which set standards for compounding nonsterile and sterile preparations. The goal was to better align these 2 chapters with USP <800> (“Hazardous Drugs — Handling in Healthc...
4月USP-NF简讯 重要修订新修订各论/通则2020年5月1日生效<795>Pharmaceutical Compounding- Nonsterile Preparations<795>药物配制-非无菌制剂关键词: 内容修订<797>Pharmaceutical Compounding-Sterile Preparations<797>药物配制-无菌制剂关键词: 内容修订Diphenhydramine Hydrochloride and Ibupro...
Simplifi 797 is a customizable, expert-developed solution that takes the effort out of Chapters USP 795, USP 797, and USP 800 compliance Optimize operations and pass inspections with the only automated, closed-loop compliance support. Improperly compounded medications can have tragic effects. USP ...
USP recently announced that it will delay the implementation of chapters on pharmaceutical compounding for nonsterile preparations (<795>) and sterile preparations (<797>), pending appeals of some sections in those chapters. As initially planned, USP <800> was deemed official as of December 1, ...
USP 800 合规性指南：评估风险说明书
＜161＞TRANSFUSION AND INFUSION ASSEMBLIES AND SIMILAR MEDICAL DEVICES (2547) 输血输液用具以及相类似的医疗器械 ＜171＞VITAMIN B12 ACTIVITY ASSAY……2548 维生素B12活性测定法 Chemical Tests and assays 化学实验与测定法 ＜181＞IDENTIFICATION—ORGANIC NITROGENOUS BASES (2549)鉴别－有机氮碱？＜191＞...
<795>PHARMACEUTICALCOMPOUNDING—NONSTERILEPREPARATIONS……2731 药物混合-非无菌制剂 <797>PHARMACEUTICALCOMPOUNDING—STERILEPREPARATIONS……2735 药物混合-无菌制剂 <801>POLAROGRAPHY……2752极谱法 <811>POWDERFINENESS……2754粉剂细度 <821>RADIOACTIVITY……2755放射性 ...
this chapter and those for nonsterile compounding in Pharmaceutical Compounding—Nonsterile Preparations 〈795〉 include, but are not limited to, ISO-classified air environments (see Table 1); personnel garbing and gloving; personnel training and testing in principles and practices of aseptic ...
The enclosures outlined below allow, with additional measures, a facility to become compliant to USP 800 requirements. These products are considered to be either Class I, Class II BSCs and LAFW's for use in compliance to USP 800 or relevant sections of USP 795 and USP 797. ...