FDA以后对企业分级 1. 严重故障，2. 重大故障，3. 轻微故障，4. 可接受，5. 超过 6...

清歌一曲月如霜

FDA以后对企业分级 1. 严重故障，2. 重大故障，3. 轻微故障，4. 可接受，5. 超过 6.优越。
FDA认为新的检查评分系统
该系统，这还没有最后确定，将提供制药公司六人得分：严重故障，重大故障，轻微故障，可以接受，超过和优越。制药公司将获得一个得分检查的各个方面，包括设施是否符合GMP要求，具有足够的质量体系和质量文化。
所提出的系统是检查的协议项目，旨在整顿检查过程等CDER得到一个更好的主意质量的设施的状态的一部分。
分数会除了传统的整体分类考虑：没有行动表明，志愿行动表示和官方的行动表明，CDER高级业务分析师尼尔Stiber，告诉DGR上个月会议在肠外药物协会的质量指标发布会后。
分数提供更多信息
分数旨在以比制药公司的广泛的分类提供更多的信息，而不会与工艺征收执法行动，如表483s干扰，Stiber说。分数也不会直接转化为检验分类，如NAI，OAI或奥钢联。
检查的分类取决于许多因素，包括之前的问题，药品供应和如何做好设施回应问题之前，他说。这些问题仍然会帮助确定inspectional结果。
该评分系统的目标是承认制造商超越满足机构的法规和GMP要求。该评分系统也将提供检查结果较广泛，整体的分类更加具体的反馈，Stiber说。
任何得分也将是除了一个设施将收到基于一系列的质量指标即将到来的排名。该排名将被用于制造比较行业的休息和确定检查频率。



FDA Considers New Inspection Scoring System
The system, which hasn’t been finalized, would offer drugmakers six scores: critical failure, major failure, minor failure, acceptable, exceeds and superior. Drugmakers would receive a score for each aspect of an inspection, including whether a facility meets GMPs, has an adequate quality system and quality culture.
The proposed system is part of an inspections protocol project that is intended to revamp the inspection process so CDER gets a better idea of a facility’s state of quality.
The scores would be given in addition to the traditional overall classifications: no action indicated, voluntary action indicated and official action indicated, Neil Stiber, CDER senior operations research analyst, told DGR after a session at the Parenteral Drug Association’s quality metrics conference last month.
Scores to Provide More Information
The scores are intended to provide more information to drugmakers than the broad classifications, and won’t interfere with the process for levying enforcement actions such as Form 483s, Stiber said. The scores also wouldn’t directly translate into an inspection classification such as NAI, OAI or VAI.
Inspection classifications depend on many factors, including prior issues, drug availability and how well the facility responded to problems previously, he said. Those issues will still help determine the inspectional outcome.
A goal of the scoring system would be to recognize manufacturers that go beyond meeting agency regulations and GMPs. The scoring system would also provide more specific feedback on inspection results than the broad, overall classifications, Stiber said.
Any score also would be in addition to the upcoming ranking that a facility will receive based on a series of quality metrics. The rankings will be used to compare manufacturers to the rest of industry and determine inspection frequency.

为胜利而来

前几年，天子脚下北京市药监局就搞过类似的，据说要全球推广之。
而且申报了专利，呵呵！

AZER

风险管理，一个思维

田天向上

好晦涩的翻译啊