FDAcGMP检查将实施评分系统

kslam

评分系统: 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 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.

晴朗柠檬

谁能翻译一下

胜利者

这是要向天朝学

一沙一叶

这个可以看看。  

一沙一叶

胜利者 发表于 2015-1-7 15:40
这是要向天朝学

我们有这种等级评定么？   

davidcone

故障？应当是缺陷吧。