ISPE指南：关键公用系统GMP合规性翻译讨论

夕玦

大佬 有下载完整版本分享么 楼主好人。

蒲公英

夕玦 发表于 2020-12-30 08:00
大佬 有下载完整版本分享么 楼主好人。

这是一个学习小组，是一个群，我只是每天分享一点儿讨论，顺便发到了论坛，所以还没有完整版本

蒲公英

2.7Process Gases 工艺气体
2.7.1General 通则

High purity gases intended for product-impact applications (except clean compressed air) include nitrogen, oxygen, carbon dioxide, and other suitable gases, or combinations of these gases. Often, compressed or liquid gases (e.g., nitrogen, oxygen) are delivered by external manufacturers. Bulk high purity gas supply systems may be equipped with backup bottles for critical uses. Care should be taken when automating these backup systems so that the manufacturer is notified (for example, an alarm is triggered) when the backup bottles have been engaged/used. In such an event, the batch production record should indicate the use of the bottles. Bottles should receive a similar level of scrutiny as other raw materials.
影响产品的高纯度气体（清洁的压缩空气除外）包括氮气、氧气，二氧化碳和其它合适的气体，或这些气体的组合。通常，压缩或液态气体（例如氮气、氧气）是由外部生产商提供的。散装的高纯度气体供应系统可能配有用于关键用途的备用瓶。自动化这些备用系统时应格外小心，以便在使用备用瓶时通知生产商（例如，触发警报）。在这种情况下，批生产记录应表明瓶子的使用情况。瓶子应受到与其它原材料相似的审查。

Common applications for these gases are:

这些气体的常见应用是：

•Blow down for drying pipes and equipment 吹干管道和设备

•Tank sparging (including fermentation and cell culture) 罐鼓泡（包括发酵和细胞培养）

•Incubation 培养

•Tank blanketing and transfer overpressure 罐填充和超压转移

Many points mentioned in Section 2.6 for clean compressed air also apply to other gases wherever there is direct product contact (including containers and closures) or contact with a product-contact surface not cleaned in a subsequent operation, and in all classified manufacturing space into which the process compressed air is exhausted. The gene and cell therapy medicines industry along with biotechnology manufacturing utilize medical gases and process air for product contact.

在第2.6节中提到的许多有关洁净压缩空气的要点，也适用于其它气体：无论它们与产品直接接触（包括容器和密封件），还是与在后续操作中未清洁的产品接触表面接触，以及在所有需要排出工艺压缩空气的洁净生产区域中。涉及产品接触时，基因和细胞疗法药物行业以及生物技术生产使用医用气体和工艺空气。

夕玦

蒲公英 发表于 2020-12-31 06:24
这是一个学习小组，是一个群，我只是每天分享一点儿讨论，顺便发到了论坛，所以还没有完整版本

好的。
十分感谢分享，楼主大度。

快活王

蒲公英 发表于 2020-12-15 13:22
2.1.4Public Water Compliance 公共用水合规

When a public drinking water source is used, the resp ...

所以有个问题，一般来说，供应商负责源水的质量情况，但是很多公司会在源水进入原水罐前或者后采取一些措施，例如过滤、加次氯酸钠等，那么这时候，我们应该是监控入厂的源水取样点还是监控原水罐的取样点？
我的个人建议是由供应商负责对进厂的源水点进行检测，控制指标参照GB，企业可以对部分参数进行检测。
原水罐的取样点由企业进行负责，根据控制措施评估对什么项目进行检测，若无法检测的话，可以委托供应商进行检测，不过这属于合同服务商的范畴了，需要对其进行管理。
个人意见，仅供参考，也欢迎多多讨论。

蒲公英

2.7.2Applicable Requirements 适用要求

Some pharmacopeias include monographs for medical gases, such as the USP [12] and Ph. Eur. [13], however, the test parameters and limits given in these monographs are intended for gases for use in patients. This is normally the application with the most stringent requirements. See Table 2.2.
一些药典包括有关医用气体的各论，例如USP [12]和欧洲药典[13]。但是，这些专论中给出的检验参数和限度是针对患者使用的气体。通常这是要求最严格的应用要求。参见表2.2.

Table 2.2: USP [12] or Ph. Eur. [13] Specifications for Oxygen, Nitrogen, and Carbon Dioxide
表2.2：USP [12]或欧洲药典[13]氧气、氮气和二氧化碳的质量标准

蒲公英

蒲公英

蒲公英

If these gases are intended to be used during a pharmaceutical process such as tank sparging, the compendial requirements may not apply completely. In specific applications (such as nitrogen in API production produced using pressure swing adsorbers) purity requirements may be relaxed based on the needs of the process. A documented rationale should be provided for the parameter limits selected.
如果打算将这些气体用于制药工艺（例如罐鼓泡）中，则药典要求可能无法完全适用。在特定的应用中（例如变压吸附API生产中使用氮气），可以根据工艺的需要放宽对纯度的要求。应为选择的参数限度提供文件化的依据。

Suppliers of gases used in processes should be governed by quality agreements, and included in the organization’s supplier qualification and supplier audit programs.

工艺中使用的气体供应商应遵守质量协议，并应包括在组织的供应商资质确认和供应商审计计划中。

Gas bottles should be traceable, with the necessary documentation and labeling[ Purchased gases should have an identification number, a material specification, vendor certificates, and should be supported by audit data and receipt testing.

购买的气体应具有识别号、材料质量标准、供应商证书，并应有审计数据和收货检验的支持。] provided by the vendor.
气瓶应是可追溯的，并具有卖方提供的必要文件和标签。

It is ultimately the responsibility of the user to determine the needs relative to their product and situation. This should be based on a risk analysis considering the requirements of the product and applicable regulatory requirements, and including respective limits and tests as necessary.

最终，用户有责任确定与其产品和使用情况相关的需求。这应基于风险分析，考虑产品要求和适用的法规要求，并在必要时包括相应的限度和检验。

鲁南冯

版主，加油，大家支持你，争取一个月内翻译完。

蒲公英

无言1 发表于 2021-1-3 16:29
版主，加油，大家支持你，争取一个月内翻译完。

翻译的动力越来越低，本来期待逐段发出来，大家一起跟着进度参与讨论，但实际看起来，关注度很低，回复的人很少，几个回复的，大多也都是谢谢、支持等没有意义和价值的留言，可能这个指南作用不大

蒲公英

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3Validation Lifecycle and Quality Systems
验证生命周期和质量体系
This chapter outlines the elements required to maintain the CU systems in a continually validated state, and the requirements of the quality systems to support this validated state. These elements are often reviewed by an auditor during regulatory inspections.
本章概述了将CU系统保持在持续验证状态所需的要素，以及支持此验证状态的质量体系的要求。通常在监管检查期间，审计师会审查这些元素。


3.1Validation验证

The topic of validation is well addressed through both the ISPE Baseline® Guide: Volume 5 – Commissioning and Qualification [2], and the ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems [25].
通过ISPE基准指南：第5卷–调试和确认[2]和ISPE良好实践指南：制药用水和蒸汽系统的调试和确认方法[25]，可以很好地解决验证问题。

Within the context of this ISPE Good Practice Guide: Critical Utilities GMP Compliance, validation documents should be presented to address the request or question specifically. They should show integration with the required elements, including risk assessment, drawings, change control, and calibration and PM programs, to demonstrate that the validated state of this system is controlled and maintained through these ongoing quality processes.
在本ISPE良好实践指南：关键公用系统GMP合规性的背景下，应出示验证文件，以应对相应的要求或问题。这些文件应显示出与所需元素的集成，包括风险评估、图纸、变更控制、校验和PM程序，以证明通过持续质量过程来控制和维护该系统的验证状态。

Fundamentally, the presentation of CU validations in an inspection should demonstrate the assessment of risk to establish the validation scope and sampling plans, qualification of the equipment included within the scope, and documented verification of system performance to predetermined acceptance criteria when operated using approved procedures and materials within normal operating conditions. Variables and sampling plans to consider during the validation are derived from the risk analysis and documented in the validation protocol and report. Verification of calibration, PM, document and drawing change control, and equipment change control should be in place prior to the closure of validation to maintain the validated state going forward.
从根本上讲，在检查中展示CU验证时，应证明对风险的评估，以建立验证范围和取样计划，对范围内的设备进行确认，并在使用批准的程序和物料，在正常操作条件下进行操作时，记录系统性能确认是否达到预定的可接受标准。验证期间要考虑的变量和取样计划是从风险分析中得出的，并记录在验证草案和报告中。在关闭验证之前，应该对校验、PM、文件和图纸变更控制以及设备变更控制进行确认，以保持持续的验证状态。

Validation efforts should always be presented with the linkages to these systems in mind so that as an inspector moves through a validation, the anticipated supporting systems described above are also available for review.
在进行验证工作时，应始终牢记与这些系统的链接，以便在检查员进行验证时，上述预期的支持系统也可用于审查。

While most regulators have not codified what constitutes the requirements for commissioning, qualification, and performance/process validation, enough best practice documents and regulatory guidances exist to establish basic rules for the validation process of CU. Typically in CU, some aspects of the design are commissioned through Factory Acceptance Testing (FAT) and/or Site Acceptance Testing (SAT), or drawing walk downs of installed piping. All other testing is done using Installation and/or Operational Qualification Protocols (IQP, OQP, and/or IOQP), and where required, Performance Qualification Protocols (PQP).
尽管大多数监管机构尚未对调试、确认和性能/工艺验证的要求进行编纂，但仍存在足够的最佳实践文件和监管指南来建立CU验证流程的基本规则。通常在CU中，设计的某些方面是通过工厂验收测试（FAT）和/或现场验收测试（SAT）进行调试的，或者是对已安装管道的施工图进行调试。所有其它测试均使用安装和/或运行确认草案（IQP，OQP和/或IOQP），以及必要时使用性能确认草案（PQP）完成。

Any new CU installation or significant modification should begin with a validation plan and end with a detailed validation summary report accompanied by a requirements traceability matrix.

任何新的CU安装或重大修改时，都应以验证计划为开始点，并以详细的验证摘要报告以及需求可追溯性矩阵结束。

nikon0001

学习，关注了。

鲁南冯

蒲公英 发表于 2021-1-3 19:03
翻译的动力越来越低，本来期待逐段发出来，大家一起跟着进度参与讨论，但实际看起来，关注度很低，回复的 ...

并不是这个作用不大，更多的是想坐享其成。说实话，我是做公用水系统、洁净气体系统、调节水系统运行管理的。你翻译的这些，真的不敢提意见或建议。如果在现场使用方面有疑问的话，可以@我。
还是非常感谢您的，继续加油努力。

鲁南冯

版主加油啊。。。。
催更了

filthy

快活王 发表于 2020-12-4 14:57
说说我的观点吧。
如果在线的检测经过了校验，且不存在污染的风险的话，在线的检测结果完全可以代替离线 ...

同意，离线检测具有较多的不可控性。

快活王

蒲公英 发表于 2021-1-3 19:03
翻译的动力越来越低，本来期待逐段发出来，大家一起跟着进度参与讨论，但实际看起来，关注度很低，回复的 ...

楼主，有一个人回复也是回复啊，我在努力发言啊，还请不要放弃

蒲公英

快活王 发表于 2021-1-8 16:58
楼主，有一个人回复也是回复啊，我在努力发言啊，还请不要放弃

独家：ISPE关键公用系统GMP合规性指南（中英文翻译）
https://www.ouryao.com/forum.php ... 653&fromuid=541
完整的已经出来了，欢迎来这里关注

蒲公英

无言1 发表于 2021-1-8 11:56
版主加油啊。。。。
催更了

独家：ISPE关键公用系统GMP合规性指南（中英文翻译）
https://www.ouryao.com/forum.php ... 653&fromuid=541
(出处: 蒲公英 - 制药技术的传播者 GMP理论的实践者)

快活王

蒲公英 发表于 2021-2-1 12:08
独家：ISPE关键公用系统GMP合规性指南（中英文翻译）
https://www.ouryao.com/forum.php?mod=viewthread ...

嗯嗯，已经下载学习了，不过还是有个讨论的氛围和环境比较好，否则每个人看的都有自己的看法和理解。