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In today’s fast-paced environment, everything needs to be done right the first time. This is especially important when releasing pharmaceutical and biological products to the market. To accomplish this, firms employ a special group of quality professionals, called the batch review/release group, to review executed batch records and be that all-important final sign-off for release to market. This is no easy task. Much of the time, these executed batch records are many pages long with complex information and data to review for accuracy. Effective and efficient management of this review process is the key to a successful process. 在当今快节奏的环境下，所有事情都需要在第一时间做好。将药品和生物制品推向市场时，这一点更是尤为重要。为了实现这一目标，企业聘请一批特殊的高素质专业人员，称为批审查/放行（release）团队，审查已执行（executed）的批记录，并承担产品上市前的最终审查工作，这并非一件易事。很多时候，这些需要被准确审查的已执行批记录包含很多复杂的信息和数据，因此对审查过程进行高效管理是建立成功的审查过程的关键。 According to the many global regulations on the topic, production and control records should be reviewed and any failure of a batch to meet specifications should be thoroughly investigated. The investigation should, if necessary, extend to other batches of the same product and other products that may have been associated with the specific failure. Most importantly, a written record of the investigation should include the conclusion and follow-up action. This is what usually slows down the batch record review process. Waiting for the investigation to be completed, reviewed, and approved and a product impact statement developed can take many days. During this time, the batch record sits in limbo awaiting its fate. Prior to these activities, however, reviewers can use the time to make sure the record is in compliance with good documentation practices (GDPs) and local and government regulations. 根据许多有关该主题的全球性法规，批审查/放行团队的审查员应对产品生产和控制记录进行审查，并对任何不合规的批产品进行彻底调查。如有必要，调查应该延伸到同一产品的其他批以及可能与特定问题相关的其他产品。最重要的是，调查的书面记录应包含调查结论和后续行动，这通常会减慢批记录审查过程。从等待审查、审查、调查、完成审查到最后制定产品影响声明（product impact statement）可能需要很多天。在这段时间里，接受审查的批产品处于等待状态，审查员可以利用这段时间来确保审查记录符合良好的文件规范（Good Document Practice，GDP）以及当地政府的规定。 1 Batch Record Review — What To Look For 批记录审查—要审查或调查什么？ Along with reviewing the records for compliance to GDPs, there are certain critical process parameters (CPPs) and critical quality attributes (CQAs) each product is assigned when being manufactured. CPPs and CQAs need to meet the expected results. If at any time they do not, an investigation is necessary. Downtime logs, clearance logs, and cleaning logs all need to be reviewed for any discrepancies or mistakes. Samples are usually taken during the manufacturing process. The number of samples, the correct aliquot, and which test it is being taken for should be confirmed by the reviewer. In addition, all environmental monitoring (EM) should be documented and reviewed for compliance to the EM program. Being that these samples are incubated over a number of days, results will be confirmed/reviewed upon batch release of the product. 除为了符合GDP规定而审查产品的生产和控制记录外，在产品的生产过程中还存在一些关键工艺参数（critical process parameters，CPPs）和关键质量属性（critical quality attributes，CQAs），CPPs和CQAs都需要达到预期结果，批审查/放行团队的审查员应对任何未达到预期结果的CPPs和CQAs进行调查。对于停工时期日志（Downtime logs）、清除日志（clearance logs）和清洁日志（cleaning logs），审查员也需要检查其是否存在任何问题或错误。批审查/放行团队的审查员通常在生产过程中对样品进行取样，并应确认样品的数量、正确的等分试样（correct aliquot）以及正在进行的试验。此外，审查员应将所有的环境监测（environmental monitoring，EM）记录形成文件并审查其是否符合EM计划。 Along with reviewing all of the scientific and technical data of the record, the reviewer must also ensure anyone who has executed a task has not reviewed their own work or reviewed that section of the batch record; all rooms used in the production of the batch should be clearly listed and their status documented, e.g., “room cleared, cleaned, and ready for use.” Any equipment calibrations need to be listed and dated. Review all comments listed by the operators in the record. If any require further investigation, notify QA or operations management. 在审查记录中所有科学技术资料的同时，审查员还必须确保执行审查的任何人没有审查自己的工作或审查批记录中的自己负责的那一部分；且审查员应清楚地列出所有在批生产过程中使用的场地，并记录下它们的状态，例如“场地已经清理干净，准备好下一次使用”。审查员应列出并注明任何设备的校准日期，也应审查操作员在记录中列出的所有注释。 All of these parameters are required to be reviewed, but not only by the quality group. Operations and quality should look for the same parameters and ensure the record adheres to the same level of compliance. When reviewing a batch record, it is imperative that the production reviewers and quality reviewers review to the same standard. In many firms, one general “batch record review” SOP is created where both groups get trained on the same procedure to ensure consistency. Also, it is helpful to have the QA group assist with the training of any production reviewers. 所有这些参数都需要进行审查，而且不仅仅是对产品质量的审查，还包括对产品生产的审查。在审查批记录时，生产审查人员和质量审查人员必须按照相同的标准对产品质量和生产进行审查，并应该参考相同的参数，确保记录遵守相同水平的标准。许多企业创建了一个通用的“批记录审查”标准操作程序（Standard Operation Procedure，SOP），以便于这两个小组的审查员接受相同程序的培训，从而确保审查标准和审查参数的一致性。 2 How To Handle Corrections To The Batch Record 如何纠正批记录？ The ultimate goal of batch record review is not merely to identify exceptions (e.g., mistakes, oversights, illegible entries), but to have the record corrected in a timely manner so it provides accurate documentation of the steps that comprise the manufacturing or packaging of the cited batch. Batch records may be reviewed for information again in weeks, months, or years after a subject batch has been manufactured or packaged or may be identified for review as part of a regulatory inspection. They need to be corrected before being stored. Ideally, all entry mistakes should be identified in the departmental review before the record is returned to QA for the quality review. If such a review is conducted, the instructions must clearly state the review is to identify any missing information and that entries are correct and within established parameters. 批记录审查的最终目的不仅仅是要识别记录中的问题（例如错误、疏忽、难以辨认的条目等），而且要及时纠正问题，以便提供准确的记录文件，包括该批产品的生产或包装记录。批记录可能在批生产或包装后的几周，几个月或几年接受再次审查，或者可能作为监管检查的一部分接受确认审查。在储存这些批记录之前需要纠正其中存在的错误。理想情况下，所有已输入的批记录错误都应在运营部门的审查中被识别，然后将其返回给质量评估（quality assessment，QA）部门进行质量审查。如果进行这样的审查，指令必须清楚地说明审查是为了识别批记录缺少的所有信息，并且确保条目正确，同时确保参数在规定的范围内。 Assuming, however, there is a question or required correction at the QA review level, the person who made the original entry (or failed to make the entry) on the batch record meets with the reviewer who identified the exception. This question or required correction is noted on the “corrections sheet” in sufficient detail to allow any subsequent person to understand the concern. After discussion, if needed for clarification, the batch record corrections are made by the operations person and verified by the reviewer. When an immediate correction is not possible due to shifts, someone on vacation, etc., the reviewer must inform the person who needs to review the batch record to specify a time this will be done. Corrections to records compete for the time of operating personnel, so it is helpful to be very specific on what the question or needed correction is. Partially completed records pose a logistical and document control challenge. A procedure is needed to describe how and where such records are to be stored and who is responsible for completion if the reviewer who started the review is not available for completion in a timely manner. 但是，如果QA部门的审查员审查出记录中的问题或需要更正部分记录，那么在批记录中进行记录原始输入（或未输入）的人员会与识别出该问题的审查员会面。被审查出的问题或需要进行的记录更正应在“更正表”上注明细节，以便其他人员了解这个问题。经过讨论后，如需更正记录，原始操作人员（即原始输入人员）则应进行批记录的更正并由审查员核实。当由于轮班、休假等原因而无法立即纠正问题时，审查员必须通知原始操作人员，并指定纠正时间。对错误的纠正或记录的更正会影响操作人员的工作时间，因此，审查员对需要纠正的问题或记录更正进行具体分析是有必要的。这种情况给记录的审查造成了一定的挑战，如果开始审查的审查员无法及时完成审查，则需要一个程序来描述如何存储这些记录，在何处存储这些记录以及由谁负责完成这些工作。 3 Why Training Is So Important 为什么培训十分重要？ One key to a successful batch record review is proper training. In many firms, the reviewers are just given a record to review with a trainer and then given authority to review a record independently. For a firm to be successful, all reviewers need to be aware of what they are reviewing. A new reviewer should first be given a tour of all operations areas and a chance to observe all parts of the manufacturing process. This allows the reviewer to become very familiar with the processes they will read about later upon batch record review. Once the reviewer has observed these operations, she should be given a blank batch record for that process to review. Upon becoming familiar with the record, she should sit and observe a trained reviewer review the batch record. Once a few observations of the trained reviewer are completed, she is now ready for a review. In many firms, a “mock” batch record is made, complete with purposeful mistakes, for the trainee to review. A certain number of mistakes cannot be missed, and the trainee receives a grade on her performance. If a passing score is achieved, the trainee is considered trained to review that batch record. These training plans can be applied to both the operations and QA departments. 成功进行批记录审查的关键之一是适当的培训。在许多企业中，学员（即通过培训且达到合格水平后便可成为审查员的人员）只是与某富有经验的审查员一同审查某一批记录后，便被授予独立审查权。要使企业取得成功，所有审查员都应该了解他们正在审查的内容。首先应使学员参观所有的操作区域，并使其有机会观察产品生产的全过程，这可以使其熟悉即将审查的批记录生产过程。在观察完这些操作后，应该给予学员未经审查的批记录以供参考。在熟悉记录后，学员应坐下来观察富有经验的审查员审查批记录。一旦这些富有经验的审查员做出了观察结果，则表示其也已经准备好对批记录进行审查。在许多企业中，存在一个“模拟”的批记录，其中包括故意制造的错误，供学员进行审查。学员避免不了在审查中犯错，企业会根据他们的表现对其进行评分。如果达到及格分数，则认为该学员已通过培训，可以对批记录进行审查。这些培训计划既适用于运营部门也适用于QA部门。 Reviewing a record is one of the most important jobs in a pharmaceutical firm. These reviewers are responsible for making sure the batch was made properly, according to procedure and regulatory requirements. Reviewers should have great attention to detail, be able to work independently, and have a thorough knowledge of the manufacturing process they are reviewing. Reviewers should be aware of the criticality of their review as well. 审查记录是制药企业最重要的工作之一。这些审查员负责根据程序和监管要求确保批生产的产品合规。审查员应高度重视细节，且能够独立工作，并对他们正在审查的生产过程有全面的了解。审查员也应该意识到审查的重要性。 By reviewing the batch record, QA and operations have the opportunity to catch errors before the product is released to the public. These reviews can save the company thousands of dollars in fines and ensure they are maintaining compliance with regulatory regulations. 通过审查批记录，使QA和运营部门有机会在产品放行给公众之前发现错误。这些审查可以为企业节省数千美元的罚款，并且确保他们遵守监管法规。 来源：OurGMP |
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