首页 > 资讯 > FDA支持在检查过程中分享对于检查员的反馈

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2016-07-23 Lachman CONSULTANTS

企业每次接受检查都有机会与了解企业合规状态前沿的检查员建立良好的工作关系。如果与检查员出现问题你会怎么办？在第120届食品和药品官员协会（AFDO）年度教育会议上，FDA监管事务办公室（ORA）高级官员被问到了这一问题。业界成员提出针对检查员行为的担忧。首要主题是对于报告检查员在检查期间的行为担心FDA的报复。

所有FDA与会代表一致认为检查员不专业的行为是领导希望并且需要了解的。此外，如果公司管理层认为行为是极其过分的，他们还鼓励管理层在检查期间联系地区办公室，而不需要等到检查结束。根据情况，可能会也可能不会立刻采取澄清行动，但会对所有的不当行为指控开展调查。至于报复，ORA官员提醒与会人有多层审查。每个级别，都会根据书面证据核实官员报告内容和FDA 483表（如果已发布的话）。

关于在检查方面的延迟，FDA官员指出，需要有正当合理的理由为什么推迟或延长检查，包括：观察到显著偏差、之前的承诺、紧急情况或员工生病。不应该成为典型理由的是，检查员每天工作时间很短，每天3-4小时，或没有合理解释的“休假”。

给企业的具体建议包括：对检查行为做笔记，实施检查和/或缺席所花费的时间，将这些证据呈现给FDA；及时报告检查行为；了解在检查期间发生的分歧；虽然行为应当保持专业并遵守法规政策，但提醒大家检查员也是人，也可能有糟糕的时候或犯错误的时候。

值得注意的是FDA检查员指导文件 — 调查操作手册（IOM）解决了这一问题。 “公众希望政府工作人员具有模范的行为和举止。” “你可能在日常现场工作中收到来自被监管企业的投诉或其它问题……请向企业提供“FDA监管企业信息”网页“www.fda.gov/oc/industry”。解释网页上在联系FDA标题下有小企业链接和FDA监察员链接，他们也可以致电地区办公室。” “希望你能审慎行事，从而有效完成FDA的工作。你的工作是收集并呈现事实。准确和客观的观察是绝对必要的。”

关键是当这种情形出现时打通与地区管理层的沟通渠道。

Lachman CONSULTANTS - Ricki Chase 先生
编译：识林-椒
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FDA SUPPORTS SHARING FEEDBACK ON INVESTIGATOR CONDUCT DURING INSPECTIONS
By Ricki Chase | July 13, 2016 原文地址

If you work in regulated industry, you will eventually be inspected by the Food and Drug Administration (FDA). With each inspection comes an opportunity to forge good working relationships with the individuals on the forefront of your compliance status. With so much riding on any given inspection, what do you do if problems arise with the investigator or analyst?

This question was asked of FDA's Office of Regulatory Affairs (ORA) senior leaders at the 120th Association of Food and Drug Officials (AFDO) Annual Educational Conference in Pittsburgh, PA. Industry members raised concerns specific to investigator behavior. The overarching theme was the fear of Agency retaliation for reporting an investigator’s conduct during the course of an inspection.

All FDA representatives present agreed that unprofessional behavior on the part of an investigator is something the leadership wants and needs to know about. Additionally, they encouraged the firm’s management to contact the District during the course of an inspection if they feel the behavior is egregious enough to warrant such, but indicated that management may wait until the close of the inspection. Officials’ clarified actions may or may not be taken immediately depending on circumstances, but all allegations of misconduct would be investigated.

As for retaliation, ORA officials reminded the audience that there are multiple layers of review. At each level, the content of the official report and FDA Form 483, if issued, are verified against the documented evidence.

Regarding delays in inspections, officials stated that there are legitimate reasons why an inspection may be delayed or prolonged, including: observation of significant deviations, prior commitments, emergency situations, or employee illness. What should not be typical is an investigator working very short days, 3-4 hours, or taking “days off” without reasonable explanation.

Specific advice for industry consisted of: keeping notes of behavior, time spent conducting the inspection and/or absences and presenting that evidence to the Agency; reporting the behavior in a timely manner; understanding that disagreements do occur during the course of an inspection; however, behavior should remain professional and policies should be followed, and, reminding everyone that investigators are only human as well, may have a bad day, or may make mistakes.

It is notable that the guiding document for FDA investigators, the Investigations Operations Manual (IOM) addresses this issue.

“The public expects exemplary behavior and conduct from the government employee.”

“You may receive complaints or other questions from the regulated industry during routine field operations…provide the firm the “Information for FDA-Regulated Industry” Website “www.fda.gov/oc/industry”. Explain there are Small Business links on the webpage and the FDA Ombudsman link is located under the Contact FDA heading, and they may also call the District Office.”

“You are expected to conduct yourself in a prudent manner, so that the work of the Agency is effectively accomplished. Your job is to gather and present the facts. Accuracy and objective observation are absolutely essential.”

The key is to open lines of communication with the District management should this situation arise.