PDA节选-洁净室的数据完整性问题-中英文版
EUGMP-中英文对照[1]
![EUGMP-中英文对照[1]](https://img.taocdn.com/s3/m/ed974fef59eef8c75ebfb3e2.png)
EU GMP ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS （中英文对照）(a) These are average values. （一）这些都是平均值。
(b) Individual settle plates may be exposed for less than 4 hours. （二）单个沉降皿放置的时间可以少于4小时。
20. Appropriate alert and action limits should be set for the results of particulate and microbiological monitoring. If these limits are exceeded operating procedures should prescribe corrective action。
对尘埃粒子和微生物的监控结果，要设置适当的警戒限度和行动限度。
当超出这些限度时，操作规程应说明需要采取的措施。
Isolator technology 隔离技术21. The utilisation of isolator technology to minimize human interventions in processing areas may result in a significant decrease in the risk of microbiological contamination of aseptically manufactured products from the environment. There are many possible designs of isolators and transfer devices. The isolator and the background environment should be designed so that the required air quality for the respective zones can be realised. Isolators are constructed of various materials more or less prone to puncture and leakage. Transfer devices may vary from a single door to double door designs to fully sealed systems incorporating sterilization mechanisms. 在生产区采用人员方面的隔离技术，在无菌产品的生产中，会显著降低周围环境微生物污染的风险。
清洁验证可接受限度(中英文版)(PDA TR 49内容节选3)
清洁验证可接受限度（中英文版）（PDA TR 49内容节选3）4.0 Acceptance Limits Cleaningvalidation is performed to demonstrate the effectiveness and consistency of a cleaningprocedure. The rationale for selecting limits for product residues, cleaning agents and microbialcontamination, as well as any other process components, should be logically based on the materials thatimpact the manufacturing process and the safety and purity of the product. The acceptable limits forcleaning manufacturing systems and component s should be “practical, achievable and verifiable.” (8)Limits for cleaning validation generally contain some measure related to the active protein (or othermajor component of interest), some measure related to the cleaning agent, some measure related tobioburden levels, some measure related to endotoxin levels, and a requirement that the equipment bevisually clean. In addition, if there are any specific toxicity concerns related to the active protein or otherprocess components (for example, cytotoxicity, al lergenicity, or reproductive hazards), the manufacturer’stoxicology or pharmacology groups may determine if a modification of limits is required, or whether theuse of dedicated equipment is needed.In the discussion that follows, issues for limits are considered based on the nature of the residue and onthe stage of manufacturing (e.g., bulk active vs. formulation/fill). Manufacturing stages include bulk activemanufacturing (all steps resulting in the bulk active drug substance) and formulation/ fill (formulation ofthe bulk active into a finished drug product and primary packaging of that drug product). Bulkmanufacturing is further divided into upstream process steps (all process steps through harvesting) anddownstream process steps (purification and following steps).4.0 可接受限度清洁验证的目的是为了证明清洁程序的高效性与一致性。
PDA TR 80 《制药实验室数据完整性管理体系》中英文对照版
The consequences of failing to uncover data integrity problems through selfdiscovery or internal internal audit programs before they are found by regulatory agency inspectors can impact the outcome of the business. Similarly, the business impact on contract manufacturers, contract laboratories, and suppliers can be very serious if they fail to uncover and disclose data integrity problems before regulators or their customers’ auditors do. One of the responsibilities of regulatory agency investigators is to verify the accuracy, reliability, and integrity of data submitted in written form or other media prior to, during, or after an inspection, or as part of a drug submission for market authorization, annual report, mandatory quality defect report (e.g., Field Alert), or Adverse
PDATR-29清洁验证中英对照（第一章—简介）
1. Introduction介绍1.1 Background背景In recent years, cleaning has achieved a position of increasing importance in the pharmaceutical industry. The current good manufacturing practices (CGMP) regulations recognize that cleaning is a critical issue to ensure product quality. Virtually every aspect of manufacturing involves cleaning, from the initial stages of bulk production to the final dosage form.近年来清洁作业逐渐在制药界占有重要的地位。
现行的GMP法规也指出清洁作业是保证产品质量的关键性工作。
自大宗原料的生产以迄最终剂型的制造作业，几乎每一个制造工序均含有清洁作业。
The CGMPs in the United States, Europe and other parts of the world have provided the pharmaceutical industry with general guidance for cleaning requirements. For example, in the U.S., section 211.67 of part 21 of the Code of Federal Regulations (CFR) states that "Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements." Section 211.182 of part 21 of the CFR identifies that cleaning procedures must be documented appropriately, and that a cleaning and use log should be established. In addition to CGMPs, various inspectional guideline documents published by the FDA contain expectations regarding cleaning in the pharmaceutical industry. Cleaning is also addressed in the PIC recommendations on cleaning validation and in the SFSTP Commission report "Validation desprocédés de nettoyage."美国、欧洲及全球其他地区均有制药界清洁作业的通则性指南。
PDA-数据完整性行为守则要素说课讲解
PDA-数据完整性行为守则要素(中/英对照版)Parenteral Drug Association Points to Consider注射剂协会考虑要点Elements of a Code of Conduct for Data Integrity数据完整性行为守则要素Introduction简介Data Integrity has been and currently is a major global concern of Health Authorities and the pharmaceutical industry.Although not a new issue, numerous recent Health Authority enforcement actions such as Warning Letters, Import Alerts, Product Detentions, and suspension or revocation of Marketing Authorizations has focused attention on Data Integrity.Data Integrity can result from lack of awareness of regulatory requirements, employee errors, failure to check accuracy of data, software or system malfunction, or configuration problems with electronic data handling, or malfeasance by employees.To holistically address Data Integrity, the Parenteral Drug Association (PDA) is developing a set of tools in the form of PDA Technical Reports, PDA Training Program, Data Integrity Workshops, and Points to Consider documents that can be used by industry to address this serious issue.This document presents the views of the Parenteral Drug Association (PDA) on the benefits for companies to voluntarily adopt a Code of Conduct for assuring data integrity.数据完整性目前已经成为全球卫生机构与制药行业所关注的重点。
完整版PDATR80制药实验室数据完整性管理体系中英文对照版
PDA TR 80 《制药实验室数据完整性管理体系》（中英文对照版）PDA TR 80 《制药实验室数据完整性管理体系》现已全文翻译完毕，大家可以点击文末“阅读原文”链接下载中英文对照版全文。
由于微信篇幅关系，这里只放出微生物实验室数据完整性的内容：5.0 Data Integrity in the Pharmaceutical Microbiology Laboratory5.0 微生物实验室的数据完整性5.1 General Considerations and Risks一般原则及风险The approaches used to investigate the occurrence of suspected data integrity issues that h recently occurred in a pharmaceutical microbiology laboratory can be challenging and, in some cases, may be very different than those used to evaluate similar occurrences in an analytical chemistry laboratory, Many microbiological methods are performed manually;subsequently, the recorded results are often based on the visual observations by an individual scientist performing the tests.制药企业微生物实验室对可疑数据完整性问题的调查方法，越来越成为一个挑战，并且在一些情况下，与同样发生可疑数据的化学分析实验室的调查方法完全不同。
很多微生物测试方法都是手动操作，以及所有的测试结果都由微生物测试人员人工检查并记录。
清洁验证之取样方法(PDA TR 49内容节选5 中英文版)
清洁验证之取样方法（PDA TR 49内容节选5 中英文版）5.0 Sampling Methods 取样方法It is essential to a cleaning validation program that the appropriate sampling techniques are utilized.Sampling must be conducted with techniques appropriate for the equipment surfaces and for the natureof the study, including the analytical methods used. This section discusses types of sampling methods,sampling recovery validation studies, and the training and qualification of samplers.在清洁消毒验证中采用适当的取样技术是必要的。
取样过程中涉及的技术方法应与设备表面和研究本质相适应，包括使用的分析方法。
这一部分讨论了取样方法的类型，验证取样回收研究以及取样人员的培训及资质。
5.1 Sampling Method Selection取样方法选择Selection of a sampling method depends on the nature of the equipment and the nature of the residue being measured. Sampling methods discussed here are direct surface sampling, swabbing, rinse watersampling and placebo sampling. It should be noted that while regulatory documents refer to swabbing as“direct” sampling and to rinse water sampling as “indirect” sampling, it is preferable and more descriptiveto refer to those sampling methods as “swab sampling” and “rinse sampling,” and reserve the term“direct sampling” for techniques such as the use of visual inspection.取样方法的选择取决于设备性质以及检测残留物的性质。
PDA TR29(1998)中英文对照版[1]
清洁剂 4.3 Microbiological Contaminants
微生物污染 4.4 Other Contaminants to be Removed
蒲公英论坛首发。Eleven 制作，未经许可请勿在其他网站和论坛发布。
次要设备——主要设备 Materials of Construction 构造材质 2.4 Product Attributes 产品属性 Low Risk——High Risk Drugs 低风险——高风险药物 Highly Characterized——Poorly Characterized 高度特性化——缺乏特性化 Non-Sterile——Sterile 非无菌——无菌 2.5 Formulation Attributes 配方属性 Solids——Liquids 固体——液体 Soluble (Active or Excipient)——Insoluble (Active or Excipient) 可溶活性成分或赋形剂——难溶活性成分或赋形剂 2.6 Operational Issues 操作上的问题 Single Product Facility——Multiple Product Facility 单品种设施——多品种设施 Campaign Production——Batch Production 连续生产——批次生产 Simple Equipment Train——Complex Equipment Train 简单设备组合——复杂设备组合
完整版PDATR80制药实验室数据完整性管理体系中英文对照版
PDA TR 80 《制药实验室数据完整性管理体系》（中英文对照版）PDA TR 80 《制药实验室数据完整性管理体系》现已全文翻译完毕，大家可以点击文末“阅读原文”链接下载中英文对照版全文。
由于微信篇幅关系，这里只放出微生物实验室数据完整性的内容：5.0 Data Integrity in the Pharmaceutical Microbiology Laboratory5.0 微生物实验室的数据完整性5.1 General Considerations and Risks一般原则及风险The approaches used to investigate the occurrence of suspected data integrity issues that h recently occurred in a pharmaceutical microbiology laboratory can be challenging and, in some cases, may be very different than those used to evaluate similar occurrences in an analytical chemistry laboratory, Many microbiological methods are performed manually;subsequently, the recorded results are often based on the visual observations by an individual scientist performing the tests.制药企业微生物实验室对可疑数据完整性问题的调查方法，越来越成为一个挑战，并且在一些情况下，与同样发生可疑数据的化学分析实验室的调查方法完全不同。
很多微生物测试方法都是手动操作，以及所有的测试结果都由微生物测试人员人工检查并记录。
PDA-数据完整性行为守则要素
PDA-数据完整性行为守则要素PDA-数据完整性行为守则要素(中/英对照版)Parenteral Drug Association Points to Consider注射剂协会考虑要点Elements of a Code of Conduct for Data Integrity数据完整性行为守则要素Introduction简介Data Integrity has been and currently is a major global concern of Health Authorities and the pharmaceutical industry.Although not a new issue, numerous recent Health Authority enforcement actions such as Warning Letters, Import Alerts, Product Detentions, and suspension or revocation of Marketing Authorizations has focused attention on Data Integrity.Data Integrity can result from lack of awareness of regulatory requirements, employee errors, failure to check accuracy of data, software or system malfunction, or configuration problems with electronic data handling, or malfeasance by employees.To holistically address Data Integrity, the Parenteral Drug Association (PDA) is developing a set of tools in the form of PDA Technical Reports, PDA Training Program, Data Integrity Workshops, and Points to Consider documents that can be used by industry to address this serious issue.This document presents the views of the Parenteral Drug Association (PDA) on the benefits for companies to voluntarily adopt a Code of Conduct for assuring data integrity.数据完整性目前已经成为全球卫生机构与制药行业所关注的重点。
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洁净室的数据完整性问题----本文摘自PDA电子期刊，适用于在线粒子系统和便携式粒子计数器：When carrying out reviews of particlecounters five general and important data integrity questions are:在进行粒子计数器的审查时，有5个常见且重要的数据完整性问题：∙Is electronic data available?∙是否有电子数据？∙Is electronic data reviewed?∙是否对电子数据进行审核？∙Is meta data (audit trails) reviewedregularly?∙元数据(审计追踪)是否定期审核？∙Are there clear segregation ofduties?∙是否有明确的职责分工？∙Has the system been validated for itsintended use?∙系统的预期用途是否经过验证？To add to theabove, ensuring that the counter has been calibrated bya competent person andits optical sensors are free fromcontamination, enable the data collected tobe reliable andrepresentative of the cleanroom environment.此外，亦须确保计数器已由合适的人员校正，其光学传感器亦没有受到污染，以确保所采集的数据可靠并能代表洁净室环境。
In addition tothese broader questions, individual particle counters should be assessedagainst regulatory data integrity expectations. The types of data integrityissues which can impact upon a particle counter, and thus which need anassessment, include:除了这些广泛的问题，粒子计数器应根据监管数据完整性的期望进行评估。
数据完整性问题的类型可能影响粒子计数器，因此需要进行评估，包括:1. Lack of definitions of data, leadingto incorrect record storage. This can arise if personnel are unaware of whatthe raw data and the original record are (such as a print-out or a pdf ofparticle data), what comprises a complete record. The definition of data shouldbe captured in a procedure.缺乏数据的界定，导致不正确的记录存储。
如果人员不知道哪些是原始数据和原始记录(如打印输出或粒子数据的pdf)？一份完整记录由什么组成？那么就会出现这种情况。
应在规程中描述数据的界定。
2. System access. Particle countersshould require password access, with each user having a unique password. Thisensures that each particle counting event is tied to a specific user, with dateand time information additionally captured.系统访问。
粒子计数器应要求密码访问，每个用户都应有一个唯一的密码。
这可以确保每个粒子计数事件都追溯到具体的用户，取样日期和时间。
3. Hierarchy of control. The particlecounter should come equipped with different levels of access. This wouldinclude, as a minimum, a basic user, who can turn the counter on and off; asupervisor level, who can change location settings and review audit trails; andan administrator who can change limits or delete data or clear buffers. Theadministrator is typically someone independent of the users, as required indata integrity guidance, and ideally independent of the departments who use theparticle counter.控制等级。
粒子计数器应该配备不同级别的访问权限。
这至少包括，一个基础用户，可以开启和关闭计数器；一个主管级别用户，可以改变采样点设置和审查审计追踪；以及一个管理员账户，可以改变限度或删除数据或清除缓存。
管理员通常由独立于用户的人员担任，正如数据完整性指南要求的那样，理想情况下是独立于粒子计数器的使用部门。
With control oflocation settings, technology is available for remote particle counters wherethe location identification is embedded in a location mounting bracket ratherthan the particle counter, which is more reliable for trending a given locationof the level of airborne particles at a specified position in the cleanroom.对于采样点设置的控制，可以利用技术将位置标识嵌入位置安装支架而不是远端的粒子计数器中，这种技术对于在洁净室指定位置确定空气中粒子水平的给定位置更为可靠。
4. In relation to passwords and accesslevels, each instrument is expected to have an approved list of users alongwith their job titles. As people leave an organization, their user name andpassword need to be removed from the counter and the user list updated by theadministrator.关于密码和访问级别，每台仪器都应有一份经核准的用户清单及其职务名称。
当人员离职时，他们的用户名和密码需要从计数器中删除，并由管理员更新用户列表。
5. Data capture, where data is capturedin temporary files. Unless particle counters are connected to a facilitiesmanagement system, the long-term storage of the raw data is not possible sincea typical portable particle counter will only hold a buffer ofa set number of data points and once the buffer is full the data isoverwritten. This means data must be printed-out or transferred at regularintervals in order to prevent data loss.数据采集，如数据被采集到临时文件中。
除非粒子计数器连接到设备管理系统，否则不可能长期保存原始数据，因为一个典型的便携式粒子计数器只能容纳一定数量数据点的缓存，一旦缓存满了，数据就会被覆盖。
这意味着数据必须定期打印或传输，以防止数据丢失。
6. Data retrieval, which follows on fromdata capture. This concerns the ability to retrospectively retrieve data aftera particle counting session and this is again linked to the ability to retrievestored data, which will be limited by the buffer overwriting and the inabilityto store data in an electronic format for long periods of time without removingthat data to a secondary source or turning that data into a record (print-outor pdf).数据检索。
这涉及到在粒子计数之后回顾性检索数据的能力，这又关系到已存储数据的检索能力，数据检索将受到缓存覆盖以及无法长时间以电子格式存储数据的限制，如不将数据转移到辅助来源或将数据转换为记录(打印输出或pdf)。
Where data canbe produced as a portable document file rather than as a print-out, this addsgreater security. The pdf cannot be adjusted, and the paper is less likely tofade. With the print-out, this is often on thermal paper, which is prone tofading. Where a facilities monitoring system is used this will bring with itsimilar data integrity concerns as with a particle counter. However, the data iscaptured electronically leading to fewer ‘touch points’compared with thestandalone counter where data typically has to be transcribed or entered into adatabase. Each data entry is a step where error can occur. Toovercome this, some particle counters have the functionality for datatransmission where data is transmitted via wired or wirelessethernet to asecure server where the user keeps the final records. This form of datatransfer can prove to be robust provided the process of data transfer has beenqualified.如数据可以生成PDF文件而不是打印文件，将增加更大的安全性。