Is there a normative source for the fact that the reviewer of a documentcannot be the same person who prepared it?
文件的審核人不能是編寫文件的同一個(gè)人，這一事實(shí)是否有標(biāo)準(zhǔn)出處?
Expert answer from a GMP inspector:
GMP檢查員的專業(yè)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.
“四眼原則”是GMP領(lǐng)域質(zhì)量保證的重要支柱。文件雙重控制原則的必要性應(yīng)基于風(fēng)險(xiǎn)考慮來決定，尤其適用于監(jiān)管機(jī)構(gòu)要求的所有文件(例如工藝規(guī)程/記錄或檢驗(yàn)規(guī)程/記錄)。在我看來，所有用以證明符合GMP要求和質(zhì)量管理體系運(yùn)行的規(guī)程和相應(yīng)的記錄都需要得到批準(zhǔn)。
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或同等文件能夠規(guī)定哪些文件應(yīng)至少根據(jù)“四眼原則（雙人）”或“六眼原則（三人）”(作者、審核人、批準(zhǔn)人)進(jìn)行審批。
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:
雖然據(jù)我所知，歐盟GMP指南中并沒有任何文件審批的正式程序，但可以找到“四眼原則”和審核的相關(guān)要求:
EU GMP Guide, Chapter 4:
歐盟GMP指南第4章：
Principles: "Suitable controls should be implemented toensure the accuracy, integrity, availability and legibility of documents."
原則：“應(yīng)實(shí)施適當(dāng)?shù)目刂疲源_保文件的準(zhǔn)確性、完整性、可用性和易讀性。”
4.2 "Documents should be designed, prepared, reviewed, anddistributed with care."
4.2“文件的設(shè)計(jì)、準(zhǔn)備、審核和分發(fā)應(yīng)小心謹(jǐn)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：“執(zhí)行工藝的每一重要步驟的操作人員的姓名(首字母)，以及在適當(dāng)時(shí)，檢查這些操作的任何人員的姓名;”
EU GMP Guide Annex 13, Article 33:
歐盟GMP指南附錄13第33條：
"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."
操作應(yīng)按照GMP原則、具體的標(biāo)準(zhǔn)操作規(guī)程和合同規(guī)定進(jìn)行，適當(dāng)時(shí)，應(yīng)由第二人復(fù)核。
211.100 (a) des CFR FDA requires theinvolvement of the Quality Control Unit in the preparation of records:
FDA CFR 211.100 (a) 要求質(zhì)量控制單位參與記錄的準(zhǔn)備工作：
"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."
這些書面程序，包括任何變更，應(yīng)由適當(dāng)?shù)慕M織單位起草、審核和批準(zhǔn)，并由質(zhì)量控制單位審查和批準(zhǔn)。
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條規(guī)定了文件的控制，并制定了明確的要求。根據(jù)DIN EN ISO 9000，如果一個(gè)文件的生命周期被定義為所有子步驟(準(zhǔn)備、審核、批準(zhǔn)、分發(fā)、舊版本撤回)，并且任何時(shí)候都可追溯，那么這個(gè)文件就是受控的。
