本帖最后由 beiwei5du 于 2017-10-20 12:17 编辑
上市后变更常见问题：
COMMON ISSUES
This section briefly summarizes commonly seen issues observed during this survey and a daily review of postapproval CMC changes, and accordingly, FDA’s expectations on how to improve supplement submission quality. Commonly seen issues include:
• Section(s) of the 2004 guidance (2) not cited to justify reporting category
• Lack of risk assessment to determine proper reporting category
• Lack of scientific reasons and/or rationale to support proposed changes
• Lack of proper investigation for OOS results
• Use of OOS results to justify new specification
• Reliance on data to justify reporting category
• Introduction of future CMC changes without supporting information
• Additional changes not listed in the cover letter
• No inspection date for site changes
• Lack of conciseness/clarification
• Too much unnecessary information provided. To improve submission quality and facilitate timely review of thousands of CMC changes yearly, it is recommended that applicants do the following:
• Properly assess risks of proposed changes against published guidance (2, 3, 8-12), quality-by-design (QbD) principles, and/or internal knowledge
• Choose reporting category based solely on the risk assessment
• Clearly identify all proposed changes with brief risk assessment in the cover letter
• Provide supporting information necessary and sufficient to justify proposed changes. 选自：<A Survey of Postapproval CMC Changes to Generic Drugs> http://www.pharmtech.com/survey-postapproval-cmc-changes-generic-drugs?pageID=4 | 
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2017-10-20 10:36:32
置顶卡
变色卡
楼主
论坛好资料真不少
感谢分享，先收藏