GMP文件的编写人和审核人可以是同一人吗？
Can the author of a GMP document also actas its reviewer?
GMP文件的作者可以同时作为审核人吗？
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Is there a normative source for the fact that the reviewer of a documentcannot be the same person who prepared it?
文件的审核人不能是编写文件的同一个人，这一事实是否有标准出处?
Expert answer from a GMP inspector:
GMP检查员的专业回答：
The 'four-eyes principle' is an essential pillar of qualityassurance in the GMP area. The necessity of a dual control principle fordocuments should be decided on the basis of risk considerations and is appliedin particular to all documents required by regulatory authorities (e.g.manufacturing instructions/records or test instructions/records). In myopinion, all instructions and the corresponding records that serve to provideevidence of conformity with GMP requirements and the functioning of the QMS aresubject to approval.
“四眼原则”是GMP领域质量保证的重要支柱。文件双重控制原则的必要性应基于风险考虑来决定，尤其适用于监管机构要求的所有文件(例如工艺规程/记录或检验规程/记录)。在我看来，所有用以证明符合GMP要求和质量管理体系运行的规程和相应的记录都需要得到批准。
I would expect that a company-internal SOP or equivalent document wouldspecify which documents are to be authorised at least according to the'four-eyes principle' or the 'six-eyes principle' (author,reviewer, approver).
期望是：公司SOP或同等文件能够规定哪些文件应至少根据“四眼原则（双人）”或“六眼原则（三人）”(作者、审核人、批准人)进行审批。
Although the EU GMP Guide does not contain any formal procedures fordocument authorisation that I am aware of, a number of references to the'four-eyes principle' and to review can be found:
虽然据我所知，欧盟GMP指南中并没有任何文件审批的正式程序，但可以找到“四眼原则”和审核的相关要求:
EU GMP Guide, Chapter 4:
欧盟GMP指南第4章：
Principles: 'Suitable controls should be implemented toensure the accuracy, integrity, availability and legibility of documents.'
原则：“应实施适当的控制，以确保文件的准确性、完整性、可用性和易读性。”
4.2 'Documents should be designed, prepared, reviewed, anddistributed with care.'
4.2“文件的设计、准备、审核和分发应小心谨慎。”
4.21 c: 'Identification (initials) of the operator(s) whoperformed each significant step of the process and, where appropriate, the nameof any person who checked these operations;'
4.21 c：“执行工艺的每一重要步骤的操作人员的姓名(首字母)，以及在适当时，检查这些操作的任何人员的姓名;”
EU GMP Guide Annex 13, Article 33:
欧盟GMP指南附录13第33条：
'The operation should be performed in accordance with GMP principles,specific and standard operating procedures and under contract, if applicable,and should be checked by a second person.'
操作应按照GMP原则、具体的标准操作规程和合同规定进行，适当时，应由第二人复核。
211.100 (a) des CFR FDA requires theinvolvement of the Quality Control Unit in the preparation of records:
FDA CFR 211.100 (a) 要求质量控制单位参与记录的准备工作：
'These written procedures, including any changes, shall be drafted,reviewed, and approved by the appropriate organizational units and reviewed andapproved by the quality control unit.'
这些书面程序，包括任何变更，应由适当的组织单位起草、审核和批准，并由质量控制单位审查和批准。
Clause 4.2.3 of ISO 9001 regulates the control of documents and formulates clear requirements.According to DIN EN ISO 9000, a document is considered controlled if its lifecycle is defined in all sub-steps (preparation, review, approval, distribution,withdrawal of old versions) and can be traced at any time.
ISO 9001第4.2.3条规定了文件的控制，并制定了明确的要求。根据DIN EN ISO 9000，如果一个文件的生命周期被定义为所有子步骤(准备、审核、批准、分发、旧版本撤回)，并且任何时候都可追溯，那么这个文件就是受控的。
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