如何起草有效的 FDA 483 回复函

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如何起草有效的 FDA 483 回复函

2014-06-30 [url=]洛施德GMP咨询[/url]

FDA 483s: 3 Steps to an effective Response Letter

如何起草有效的FDA 483回复函

Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to you since you have only 15 working days from the receipt of the 483 to respond!

对FDA和其他国际法规机构监管的企业来说，任何失误都可能导致严重的后果，例如产品被没收、被召回，甚至是企业停产关闭。因此，如何在仅有的15个工作日内应对FDA483调查结果表、警告信及其他重大事件是至关重要的。

Step1. Wording Your Response Letter

步骤一：注意回复函的措辞

Never respond to 483s in a casual, conversational manner and try to explain or justify what happened; Instead, you must use a critical thinking process to ensure that your response adequately addresses all of the issues raised by the 483 (with supporting documentation as warranted) without making promises that cannot be fulfilled or committing to unrealistic deadlines.

483回复函不可以口语化，应采用正式的书面语言。另外，在回复函中不要重申发生了什么，而应该采用批判性的思考方式书写回复函，确保回复内容包括483中所有列举问题的合理解决方法。回复函不应是空口承诺，不可能实现的解决方法或是不合理的问题处理期限，都不能出现在回复函中。

If you over promise and under deliver (i.e., the 483s comes back), there is a good chance you’ll receive a second write up for the same violation, which almost guarantees that you’ll receive a warning letter.

如果不能落实回复函中的整改内容，FDA很有可能还会再度来信，且日后在所难免接到FDA的警告函。

Step2. Response Must Be Transparent and Comprehensive

步骤二：回复函必须清晰且全面

It’s not the “why” a particular non-conformance may have occurred but “what” corrective actions you intend to take to remedy the situation — and “when”

回复信中强调的不是为什么会发生不合规情况，而是要重点突出所要执行的整个措施和更改措施执行的具体时间。

No remediation plan is complete unless it includes progress milestones, which outline the steps you intend to take toward resolution, as well as hard deadlines for completing your corrective actions.

进度安排（整改措施的执行步骤大纲）、完成整改措施的截止期限应在整改计划中，否则整改计划不完整。

The key is to show investigators that you understand the consequences of the deviation (e.g., the deviation had such and such impact). Be sure to explain each aspect of the resolution carefully to demonstrate not only asuccessful resolution to the problem, but also the company’s commitment to prevent reoccurrence.

书写回复信的关键是向调查人员证明自己完全了解偏差造成的后果（例如：偏差的种种影响），并对整改措施进行完整说明，证明整改措施不仅能够解决问题，且可以确保问题不会再次发生。

Convince investigators that you are remedying the problem to satisfy not only safety and compliance issues, but also because it will make your business better.

回复函的内容应对调查人员有一定的说服了，能够向调查人员证明问题的解决方案基于企业长远的发展，其不仅适用于当前问题的解决，更有利于企业之后的发展。

Step3: The Response is Just the Beginning …

步骤三：回复函仅仅只是开始

Many recipients panic when they receive a 483, but forget about it once the response letter is out the door. Remember constant review measurements must beimplemented to assure regulators of your commitment to continuous quality improvement and compliance.

在接到483时，大多数的企业都会担忧、不知所措，可是一旦回复信寄出后，企业就会把483的警告抛到脑后。企业应该进行持续审核，向监管机构证明自己能够持续完善产品质量，并不断符合法规的要求。

In short, crafting the response letter is just the beginning: follow up is critical to successful remediation. After you’ve sent off your response, we recommend conducting a mock audit or GAP analysis in preparation for FDA’s return.  

简而言之，回复信对于企业仅仅只是个开始，持续改进才能够纠正错误。如果企业完成了回复信，建议企业进行第三方审计或差异分析，迎接FDA的下次检查。

483s are often a symptom of a much larger issue. Dig deep, uncover the rootcause of the problem, and you’ll show the FDA that you are doing more than the minimum required.

通常问题严重时可能导致483。如果能够深入研究、发现问题的本质，企业向FDA证明的就不仅仅是自己只能达到它的基本要求了

幻影

真正执行汇报，非应付。