New and Revised Draft GMP Guidances FDA is planning to publish 2017

2017年FDA拟修订/增加GMP指南

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has published a Guidance Agenda with planned new and revised Draft Guidances for the calendar year 2017. Amongst these documents are a few which might be interesting for the GMP area, for example:

FDA药品评价研究中心公布了一个2017年度计划增加和修订的指南草案的指导议程。其中有些是关于GMP领域的:

Bioanalytical Method      Validation; Revised Draft

生物分析方法验证（修订草案）

Container Closure      Systems for Packaging Human Drugs and Biologics; Revised Draft

人用药和生物制品包装容器密封系统（修订草案）

Drug Master Files;      Revised Draft

药物主文件（修订草案）

Visual Inspection of      Injectable Drug Products

注射用药品目视检查

Current Good      Manufacturing Practice for Medical Gases; Revised Draft

药用气体CGMP（修订草案）

Expiration Dating of      Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft

口服固体制剂药品剂量单位重新包装有效期

Field Alert Report      Submission

FAR提交

Repackaging of Certain      Drug Products by Pharmacies and Outsourcing Facilities

药房和外包厂房药品重新包装

The items of the Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017 reflect draft and revised draft guidances under development as of the date of FDA's posting. So there might be more to come.

指导议程：CDER计划于2017年度公布的新增&修订草案指南 只包含了FDA截至发布之日为止所编制的指南草案和修订草案。因此到时候可能还会有更多出来。