写在前面的话：
在GMP概念已经逐渐成熟被深入人心，GMP检查已经可以轻松面对的年代，制药行业开始看到恐怖的一幕拉开：非GMP行为、记录和证据开始被牵涉被检查，甚至被作为缺陷写入483！GMP检查这是要上天么？只有你想不到，没有人家查不到！让我们一起学习学习知名组织的良心说法（能不能派上用场就看你有没有胆量了）！
——本文来自PDA 7月15日电子杂志，翻译帮助：Julia朱玉娇／原文官网链接：http://journal.pda.org/content/72/3/332.full.pdf+html
——
Background and Purpose
背景和目的
Basedon its own experience and through a broad industry survey conducted withsupport from the Association for Accessible Medicines (AAM) and the Pharma& Biopharma Outsourcing Association (PBOA), PDA has identified current questionsrelated to data management and control that have been frequently cited in FDAinspections or have led to FDA regulatory actions. The PDA Data Integrity Task Forcehas selected eleven questions to address at this time and included recommendedbest practices for each situation. The purpose of this document is to help toclarify these issues for industry and to help facilitate better compliance bysharing PDA members’ expertise in and understanding of current best practices.
根据其自身经验，通过广泛的企业调查，在AAM和PBOA支持下，PDA识别出了当前与数据管理和控制有关的一些问题。这些问题曾被FDA检查频繁指出或导致FDA法规措施。PDA数据完整性工作组此次选择了11个问题来进行说明，其中包括有在各种情形下的最佳规范建议。此文件的目的是通过分享PDA成员的专业知识与对当前最佳规范的理解帮助企业澄清这些问题，帮助工厂更好地实现合规。
Dataintegrity inspectional observations by health authorities can have a severeimpact on a firm from a regulatory and public perception perspective and shouldnot result from a lack of clarity by industry about what is required. Inaddition, firms are concerned that the inability to produce a requested recordor document during an inspection, even if not a standard report or existingquality system document, could be construed as delaying, denying, limiting, orrefusing inspection, which also has significant consequences.
药监机构的数据完整性检查缺陷在法规和公众观念方面可能会有很严重的影响，不应该是由于企业缺乏对所需工作的了解而造成。另外，在检查期间，企业没有能力生成所需记录或文件会受到关切，即使不是标准报告或现存质量体系文件，这可能会构成拖延、否决、限制或拒绝检查，这也会产生严重后果。
Question 1: Copies of GMP Records
问1：GMP记录副本
Context: 背景
Ona daily basis, there are many valid reasons why a firm may wish to make copiesof GMP records, including records that contain a lot number, batch-specificdata, test results, or other data. For example, firms may make a copy of abatch record to provide to a Technical Services group to conduct aninvestigation. Especially in light of recent 483 observations that highlightdocuments with batch information found in a shredder, it is unclear under whatconditions it is permissible to treat copies of GMP records as uncontrolled,non-GMP records. Requiring that the issuance, management, and destruction ofall of these documents be controlled by the Quality Unit imposes an unnecessaryburden on industry. The key is for firms to be able to show how they assurethat an original record is the original record and that the data in the recordsatisfy ALCOA principles.
在日常工作中，公司有许多合理理由想要复制GMP记录，包括含有批号、批特定数据、检验结果或其它数据的记录。例如，公司可能会复印一份批记录，提供给技术服务组执行一个调查。尤其是在最近的483缺陷中，重点强调了在一个碎纸机中发现有批信息的文件，然后并不清楚是在何种情况下允许将GMP记录的副本作为非受控、非GMP记录对待。要求将所有这些文件的签发、管理和销毁都受质量部门控制会给企业带来不必要的负担。关键的是公司要能显示出他们是如何确保原始记录是原始记录，并且记录中的数据满足ALCOA原则。
Issue: Is a copy of a GMPrecord (e.g. printout of the raw data or photocopy/scan of a paper originalrecord) itself considered a GMP document?
问：GMP记录的副本（例如，原始数据的打印件或纸质原始记录的影印件/扫描件）自身就被认为一份GMP文件吗？
Clarification:As long as firms have full control over original GMP documents and the originalGMP document is retained as required by the firm’s procedure, copies can becreated and destroyed as needed. A copy of a GMP record need only be retainedif additional GMP information (e.g., raw data) is recorded on the document copy. As a partof maintaining control over GMP records, it is advisable to make sure thatcopies can be readily distinguished from originals (e.g., copies are stamped as“copy” and/or originals are stamped as “original”).
澄清：只要公司对原始GMP文件有全面控制，并且原始GMP文件按公司程序保存，在需要时可以创建和销毁副本。一份GMP记录的副本只有当在其上记录了其它GMP信息（例如，原始数据）时才需要保存。作为对GMP记录保存控制的一部分，建议确保副本可以易于与原始件区分（例如，副本加盖“复印件”章和/或原件加盖“原件”章）。
Question 2: Documents not traditionally considered GMPrecords
问题2：文件并非传统意义的GMP记录
Context: 背景
In recent483s, we have observed that documents not traditionally considered GMP records(e.g., e-mails and other communications) become the object of scrutiny andobservations. A working definition of what the agency currently views as a GMPrecord for such things as e-mail, supervisor schedule, etc. would be helpfulfor industry. Firms communicate informally about production and quality-relatedactivities on a continuing basis in order to facilitate operations. An e-mailregarding batch release may be essentially the written equivalent of a phonecall from one colleague to another stating that a batch has been released.Requiring formal controls around all of these documents, or requiring that suchdocuments cannot be printed and discarded/destroyed/shredded at will, creates alarge burden on firms and their quality units.
背景：在最近的483中，我们发现传统上并不认为是GMP记录的文件（例如，电子邮件和其它通讯信息）成为了监督和缺陷的对象。官方目前将何种文件视为GMP记录（如电子邮件、主管日程等）如果有一个工作定义，将对会企业大有帮助。为了便于运营，公司会持续沟通关于生产和质量活动的讯息。一份关于批放行的电子邮件可能基本上等同于一位同事向另一位同事说明一个批次已放行的书面形式。要求正式控制所有这些文件，或要求此类文件不能任意打印出来和丢弃/销毁/碎掉，会对公司及其质量部门造成很大负担。
Issue: Are e-mails or other papersthat contain batch-related information such as product name, lot number, ortest results considered GMP records if local procedures are clear on what isthe system of record?
问：如果公司的程序非常清楚规定了记录系统是什么，电子邮件或其它含有批相关信息如品名、批号或检测结果的纸张会被认为是GMP记录吗？
Clarification:Whether a document is considered a GMP record depends on whether it is generatedto satisfy a GMP requirement (see Data Integrity and Compliance with CGMP,Guidance for Industry, April 2016 draft, “When generated to satisfy a CGMPrequirement, all data become a CGMP record.”) For example, if e-mail is used asa record of batch release, it is a GMP document. If e-mail is used tocommunicate that a batch has been released, but the system of record for batchrelease is not e-mail, then the e-mail is not a GMP record. Similarly, draftsof risk assessments, investigation reports, etc. are not cGMP records untilthey have been reviewed and finalized. If companies use e-mails for GMPpurposes, it is advisable to have a controlled process, governed by an SOP.
澄清：一份文件是否被认为是GMP记录取决于其生成是否为了满足一个GMP需求（参见行业指南：数据完整性和CGMP合规性，2016年4月草案，“所有为了满足CGMP要求而生成的数据均为CGMP记录”）。例如，如果一封电子邮件被用来作为批放行的记录，则其就是一份GMP文件。如果电子邮件用于沟通一批已被放行，但批放行记录系统并不是电子邮件，则电子邮件并不是一份GMP记录。类似地，风险评估的草案、调查报告草案等在其被审核并定稿之前均不是CGMP记录。如果公司使将电子邮件用作GMP目的，则建议制订一个受控程序，由一份SOP来管理。
Question 3: Personal Diaries
问题3：个人日记
Context: 背景
It is commonfor employees to use personal diaries or paper to record notes for themselvesfor non-GMP purposes e.g. to-do list, training notes, personnel information.These notes are not considered to be GMP records by industry in general.Turning these notes into GMP records may in fact deter individuals from writingdown information that is useful for effective time management or reinforcingone’s own learning.
员工经常会使用个人日记 或纸张自己记录一些非GMP的事情，如任务清单、培训笔记 和个人信息。一般来说企业不会认为这些笔记是GMP记录。将这些笔记转为GMP记录可能实际上会让员工不敢把一些进行有效时间管理或强化个人学习的有用信息写下来。
Issue: What types ofentries/information can be recorded in a personal diary without it being consideredGMP record?
问题：什么类型的输入/信息可以记录在个人日记中而不会被认为是GMP记录呢？
Clarification:If notes and diaries are used as personal and informal means of recording and arenot the system of record for execution or documentation of GMP activities, thenthey are not considered to be GMP records. These informal recordings inpersonal notebooks might include to-do lists, training notes, coaching ideas,personnel information, etc.). Firms may want to consider controlling and spotchecking personal notebooks to ensure that they are being used only for non-GMPinformation. Firms may also want to train employees on what is and is notproper for recording in personal notebooks.
澄清：如果笔记和日记用作个人记录参考信息的方法，并不是GMP活动执行或文件化的记录系统，则并不会认为它们是GMP记录。这些写在个人笔记本上的非正式记录可能包括任务清单、培训笔记、教导想法以及个人信息等。公司可能想进行控制，并抽查个人笔记 以确保员工只会将其用于非GMP信息记录。公司亦可能想要培训员工，告知其在个人笔记中记录什么是恰当的，以及记录什么是不恰当的。
Question 4: Drafts of GMP documents
问4：GMP文件的草稿
Context: 背景
Firms generatemany drafts of CGMP documents. It would be onerous and confusing to requirethat all of those documents be retained.
公司会产生很多CGMP文件的草案。如果要求保留所有这些文件，可能会很麻烦并造成混淆。
Issue: Are firms required to retaindrafts of CGMP documents, such as reports of risk assessments, investigations,and validation?
问：公司需要保存CGMP文件的草案吗？如风险评估报告、调查报告和验证报告草案
Clarification:Once a final GMP document of record is created, drafts and documents used in thecreation of the document of record no longer need to be retained. This includesdocuments and drafts used or created in the course of conducting aninvestigation. The final document is the document of record. GMP Change Controlprocesses come into effect once a GMP document is formally approved. As a partof maintaining control over GMP documents, it is advisable to make sure thatdrafts can be readily distinguished from final documents (e.g., they arestamped as “draft”).
澄清：一旦GMP文件最终成稿，就不需要保留用于记录文件创建的文件和草案了。其中包括有在执行调查过程中使用或创建的文件和草案。最终文件是记录文件。一旦正式批准了一份GMP文件，则GMP变更控制流程生效。作为保持GMP文件控制的一部分，建议确保草案可以明显区别于最终文件（例如，盖有“草案”印章）。
Question 5: Emails as GMP records
问题5：电子邮件作为GMP记录
Context: 背景
Firms usee-mail for a variety of GMP and non-GMP purposes. It is unclear to many firmswhich uses constitute GMP uses and whether a firm’s entire e-mail systembecomes a GMP system due to its use.
公司使用电子邮件有不同的GMP和非GMP目的。许多公司不太清楚哪种使用方法算是GMP用途，公司的整个电子邮件系统是否要因为此类用途而成为一个GMP系统。
Issue: Are e-mails considered to beGMP records?
问：电子邮件会被认为是GMP记录吗？
Clarification:Whether e-mails are GMP records depends on whether they are being used to communicateGMP actions or content or capture GMP decision-making.
澄清：电子邮件是否GMP记录取决于他们是否被用于交流GMP行动或内容或获取GMP决策。
For example,if e-mail is used as the system of record for batch release, then those e-mailsare GMP records, and local procedures should be clear on what is the system ofrecord. If e-mail is used to communicate that a batch has been dispositioned,but that decision is formally captured elsewhere in accordance with the firm’sSOPs, then the e-mail is not a GMP record. Similarly, if e-mail is used as the officialsystem for escalation of quality issues per a firm’s SOPs, then those e-mailsare GMP records. If e-mail is used for informational purposes to note thatthere has been an escalation, and there is a separate system of record forescalations, then the e-mail is not a GMP record. The use of e-mail in GMPprocess(es) should be well-described in the relevant SOP(s).
例如，如果电子邮件被用作批放行记录系统，则这些电子邮件就是GMP记录，并且内部需要有程序写清楚记录系统是什么。如果电子邮件被用于交流一个批次是否已经被处置，但该决策是依据公司的SOP从其它地方获取的，则该电子邮件就不是GMP记录。类似地，如果电子邮件依据公司SOP被用作质量问题升级处理的正式系统，则这些邮件就是GMP记录。如果电子邮件被用作通知提醒该升级处理事件，并且还有另一个单独的系统用作升级记录，则该电子邮件就不是GMP记录。在GMP流程中使用电子邮件应在相关SOP中清楚描述。
To create aGMP record that is separate from the e-mail system, and to avoid an e-mailsystem being used as a GMP system of record, a firm may wish to considerprinting, signing/initialing, and dating all of the relevant e-mails thatconstitute a GMP record. All of this should be done in accordance with a writtenSOP.
为了创建一份独立于电子邮件系统以外的GMP记录，也为了避免使用电子邮件系统作为GMP记录系统，公司可能会希望考虑将所有含有GMP记录的相关邮件打印出来并签名加日期。所有这些操作均应依据书面SOP完成。
Question 6: Business records that are not GMP records
问题6：不是GMP记录的商务记录
Context: 背景
Recent inspectionshave delved into business records that are not GMP records, such as footagefrom security cameras, drafts of GMP documents such as investigations,uncontrolled document copies, and security key card access systems. FDA maychoose to inspect these items and may even use them as a means of finding GMPviolations. However, the fact that records may be inspected should not meanthat these items are GMP records. Otherwise, it would create an enormous burdenon the Quality Unit to review and control new kinds of records.
最近的官方检查开始查阅非GMP记录的商务记录，如安保录像、GMP文件如调查文件的草案、非受控文件副本，以及安全钥匙卡出入系统。FDA可能会选择检查这些项目，甚至可能利用其作为发现GMP违规行为的方法。但是，这些记录可能会被检查的事实并不表示这些事物都是GMP记录。否则，将会对质量部门造成巨大的负担，方可对新类型的记录进行审核和控制。
Issue: If non-GMP records, such asfootage from security cameras, drafts of GMP documents such as investigations,uncontrolled document copies, and security key card access systems are inspected,does that mean that they are considered to be GMP records?
问：如果要检查非GMP记录，如安保录像、GMP文件如调查的草案、非受控文件副本，以及安全钥匙卡出入系统，是否表示这些都被认为是GMP记录？
Clarification:No. When generated to satisfy a CGMP requirement, all data become a CGMP record.But the fact that a non-GMP record may be subject to inspection or may be thesource of an inspectional observation pertaining to a GMP issue does not turn itinto a GMP record. However, if a system is intended to provide documentedevidence of a GMP function or GMP result then it is a GMP system. For example,if a key card entry system is used beyond employee exit and entry and is usedas a log to monitor time spent in an aseptic core for purposes of media fillcompliance, then it is being used for GMP purposes and should be clearlydefined as such by local procedure. However, if such a system is evaluated onan occasional retrospective basis as part of a GMP investigation to ensure thatan employee did not over-stay in the aseptic core, then that does not mean itshould be considered a GMP system. Of course, any documentation from thatsystem that is part of an investigation should be kept (in paper or electronicform) as a part of the investigation.
澄清：不是。所有为了满足CGMP要求而生成的数据是CGMP记录。但非GMP记录可能会被检查，或可能成为与GMP问题有关的检查缺陷的来源的事实，并不会将受检查的非GMP记录转化为GMP记录。但是，如果一个系统的目的是为一项GMP功能或GMP结果提供文件化证据，则其就是GMP系统。例如，如果一个钥匙卡门禁系统被用于员工进出以外的控制，并且被用作培养基灌装合规的无菌中心里停留时间监测的日志，则其就是被用于了GMP用途，应该在内部程序里清楚定义。但是，如果此系统只是偶尔回顾性地作为GMP调查一部分进行评估，以确保员工并未在无菌中心超时停留，则该系统并不一定被认为是GMP系统。当然，该系统中作为调查部分的文件记录应该保留作为调查的资料。
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