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https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/778086/Guidance_on_responding_to_a_post_inspection_letter_February_2019.pdf
Guidanceon responding to a GMP / GDP post inspection letter
GMP/GDP检查后回复函指南
This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
本指南用于减少准备检查后回复函的工作负担。
This format is not mandatory, but is the inspectorate’s preferred method for providing responses and should help to reduce the time taken to reach a compliance decision after the inspection.
本格式并非强制，但检查员倾向于采用此格式提交回复，有助于缩短检查后做出合规决定的时间。
The guidance is presented in the same format as the deficiency annex to a GMP/GDP post inspection letter.
本指南与GMP/GDP检查后信函缺陷附录格式相同。
1 CRITICAL 关键
(Critical deficiencies will be more complex in nature and responses may take different formats depending on the issues cited. Specific guidance is therefore not provided, but the general principles below apply).
关键缺陷性质更为复杂，根据所发现问题，其回复可能会需要有不同格式。因此不提供具体的指南，但以下的通则亦适用。
2 MAJOR 主要
2.1 This is a Major deficiency.在此写下主要缺陷原文
2.1.1 There may be a number of examples provided on a deficiency. 在一个缺陷中可能会有数个缺陷举例。
EU GMP CX, CX.1, CX.2 etc
Initial Site Response 工厂首次回复
• Choose a new colour for your first set of responses.
• 为首次回复选择一个新的颜色
• Answer the deficiencies raised directly underneath, preferably on the same document provided.
• 直接在下面回答所提出的缺陷，******是在同一文件中提供
• Verbose responses with information not directly relevant to the remediation actions may be returned without review with a request to rewriteand simplify (these type of responses are not an efficient use of the inspectors’ or the company’s time).
• 如果回复冗长，其中信息与补救措施并非直接相关，则可能会不加审核直接退回，要求重写并简化（此类回复浪费检查员和公司的时间）
• State clearly what you are going to do and when you are going todo it (DDMMYYY). If your response is a commitment to ‘review a system’, then state when the review will be complete and what will happen with the output of the review, the inspector may request that the output be provided.
• 清楚声明你们要做什么，将在何时去做（DDMMYYY）。如果你的回复是承诺“审核一个系统”，则应声称何时完成审核，审核结果出来后会做什么，检查员可能会要求提交审核结果。
• Think about the wider (systemic) issue, including other sites in the organisation and do not just respond with a correction to the single identified point.
• 想一想更广泛的（系统性的）问题，包括组织机构的其它场所，而不仅回复单个发现点的纠正措施。
• If you have reviewed all similar areas to find other examples of the deficiency, but no others were found, clearly state this and include a description of how the system review was performed.
• 如果你们已审核了所有类似部分，试图找到该缺陷的其它例子却并未发现，则应清楚写明，并在其中包括如何审核系统的描述。
• Choose appropriate timelines that are realistic (do not give extended times for simple actions).
• 选择实际可靠的恰当的时间表（不要为简单的行动给出超长的时间限）。
• Where timelines are long due to the complexity of the solution,but operations are continued, consider interim actions. These should be designed to protect the patient until the longer term action is complete.
• 如果因为解决方案很复杂导致时间表很长，但仍需继续该操作，则应考虑制订临时措施。临时措施应设计用以保护患者直到长期措施完成。
• Do not provide evidence of what you have done, unless specifically asked to.
• 不要提交你已经做了什么的证据，有具体提出此要求时除外。
• Provide your response in an editable Word document to allow the inspector to respond (if required).
• 采用可编辑的WORD文件提交回复，使得检查员可以回应（必要时）。
• Hard copies are not required and will not be reviewed.
• 不需要纸质副本，即使提交亦不会审核。
MHRA first request for further information 官方首次要求更多信息
• If the inspector requires further information, they will choosea different colour and put the request directly below the point that they require information for.
• 如果检查员需要更多信息，他们会选择不同颜色并在他们需要的信息点下面直接提出索取要求。
• The use of different colours for each set of responses allows each party to clearly identify which points require further response.
• 每套回复需使用不同颜色，让双方可清楚找到需要进一步回复的各点。
Site Second Response 工厂第二次回复
• The site should choose a new colour for all sets of responses and reply underneath the further request.
• 工厂应选择一个新的颜色用于全套回复，在进一步要求下面作答。
• The whole record of all responses will therefore be in a single document.
• 所有回复的整个记录会在同一个文件中
• Do not change previous responsetext when you are providing additional information or further responses.
• 在提交其它信息或进一步回复时，不要改变之前的回复文本内容
3 OTHERS 其它
3.1 This is a deficiency that is classed as an ‘Other’. 此处写下分级为其它的缺陷原文
EU GMP CY, CY.1, CY.2 etc
Initial Site Response 工厂首次回复
• Follow the same format for responses as outlined above.
• 按上述所列回复相同格式书写
4 COMMENTS 建议
4.1 This is a comment, not a deficiency. 在此写下不是缺陷的建议
Initial Site Response 工厂首次回复
• The site should respond to comments, even if it is just to acknowledge them.
• 工厂应对建议给出回复，即使只是知会当局
Please be aware that you are required to communicate with the inspector(s) if you are going to miss a timeline commitment. This communication should take place before you go beyond the due date. The post-inspection compliance decisions are based on the acceptance of the remediation actions and their associated timescales for completion. The interim compliance report can be used to notify of delays to commitments completion.
记住，如果你们赶不上时间限承诺，那你们要与检查员沟通。沟通要在超出时间限之前进行。检查后的合规决定是基于接受补救措施及相关完成时间表的基础上的。可能会使用临时合规报告通知承诺完成延迟情形。
February 2019
