EUGMP附录1无菌产品生产-2020版（中英文对照）
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EUGMP 附录 1 无菌产品生产-2020 版（中英文对照）
Annex 1 : Manufacture of Sterile Products
EU GMP 附录 1 无菌产品生产-2020 版
1 Scope
范围
The manufacture of sterile products covers a wide range of
sterile product types (active substance, sterile excipient, primary
packaging material and finished dosage form), packed sizes
(single unit to multiple units), processes (from highly automated
systems to manual processes) and technologies (e.g.
biotechnology, classical small molecule manufacturing and
closed systems). This Annex provides general guidance that
should be used for the manufacture of all sterile products using
the principles of Quality Risk Management (QRM), to ensure
that microbial, particulate and pyrogen contamination is
prevented in the final product.
无菌产品的生产涵盖了广泛的无菌药品类型（活性成分，无菌辅
料，内包材和制剂），包装量（从单个单位到多个单位），工艺（从
高度自动化系统到人工操作）和技术（例如生物技术，常规小分子生
产以及密闭系统）。本附录运用质量风险管理(QMR)原则为所有无菌
产品提供总体指导原则，用以避免最终产品中来自微生物，颗粒以及
热原方面的污染。
QRM applies to this document in its entirety and will not be
referred to in specific paragraphs. Where specific limits or
frequencies are written, these should be considered as a
minimum requirement. They are stated due to regulatory
historical experience of issues that have previously been
identified and have impacted the safety of patients.
本文件的全部内容均适用 QRM（质量风险管理），而不是某个章
节。当章节中规定特定限度或者频次时应视为最低要求，这些规定通
常基于所出现问题的监管历史经验。曾经识别出这些问题，它们对病
患安全造成过影响。
The intent of the Annex is to provide guidance for the
manufacture of sterile products. However, some of the
principles and guidance, such as contamination control
strategy, design of premises, cleanroom classification,
qualification, monitoring and personnel gowning, may be used
to support the manufacture of other products that are not
intended to be sterile such as certain liquids, creams, ointments
and low bioburden biological intermediates but where the
control and reduction of microbial, particulate and pyrogen
contamination is considered important. Where a manufacturer
elects to apply guidance herein to non-sterile products, the
manufacturer should clearly document which principles have
been applied and acknowledge that compliance with those
principles should be demonstrated.
本附录旨在为无菌产品的生产提供指导，然而有些原则和指导，
例如污染控制策略，厂房设施设计，洁净区级别，确认，监测和人员
更衣，可用于支持其他非无菌产品的生产（例如特殊液体制剂，膏剂
软膏剂以及低微生物负载的生物制品中间体）,特别适应于控制和降低
微生物，颗粒和热原污染非常重要的情况。当生产厂家选择将此指南
应用于非无菌产品时应清晰记录所应用的原则以及这些原则的符合情
况。
2 Principle
原则
2.1 The manufacture of sterile products is subject to special
requirements in order to minimize risks of microbial, particulate
and pyrogen contamination. The following key areas should be
considered:
无菌产品的生产应符合特定要求，以减少来自微生物, 颗粒及热原
方面的污染风险, 应考虑到以下关键区域：
i. Facility, equipment and process design should be
optimized, qualified and validated according to the relevant
sections of the Good Manufacturing Practices (GMP) guide. The
use of appropriate technologies (e.g. Restricted Access Barriers
Systems (RABS), isolators, robotic systems, rapid microbial
testing and monitoring systems) should be considered to
increase the protection of the product from potential
extraneous sources of particulate and microbial contamination
such as personnel, materials and the surrounding environment,
and assist in the rapid detection of potential contaminants in
the environment and product.
厂房设施，设备及工艺设计应根据良好药品生产管理规范
（GMP）相关附录中的要求进行优化，确认和验证。应考虑采用适当
技术手段（例如，限制进入屏障系统（RABS），隔离器，机器人系统，
快速微生物测试和监测系统）以加强从潜在外来微粒和微生物污染
（例如人员，物料及周边环境）中对产品进行保护，并实现对环境和
产品中的潜在污染的快速识别。
ii. Personnel should have adequate qualifications and
experience, training and attitude with a specific focus on the
principles involved in the protection of sterile product during
the manufacturing, packaging and distribution processes.
人员应有充分资质，经验，培训和态度，能够重视用于在生产、
包装及发运过程中保护无菌产品的原则。
iii. Processes and monitoring systems for sterile product
manufacture should be designed, commissioned, qualified and
monitored by personnel with appropriate process, engineering
and microbiological knowledge.
无菌产品的生产工艺及监测系统应由具有合适的工艺、工程以及
微生物知识的人员进行设计、调试、确认和监测。
2.2 Processes, equipment, facilities and manufacturing
activities should be managed in accordance with QRM
principles to provide a proactive means of identifying,
scientifically evaluating and controlling potential risks to quality.
Where alternative approaches are used, these should be
supported by appropriate rationales and risk assessment and
should meet the intent of this Annex.
工艺、设备、厂房设施及生产活动应基于 QRM 原则进行管理，
该原则提出了一个前瞻性的方法用于识别、科学评估及控制对质量的
潜在风险。使用替代方法应经恰当依据和风险评估支持，并符合本附
录目的。
QRM priorities should include good design of the facility,
equipment and process in the first instance, then
implementation of well-designed procedures, with monitoring
systems as the final element that demonstrate that the design
and procedures have been correctly implemented and continue
to perform in line with expectations. Exclusively monitoring or
testing does not give assurance of sterility.
QRM 优先事项首先是厂房设施，设备和工艺设计的优良设计，其
次是对良好设计规程的实施，最后以监测系统证明设计和规程的正确
实施以及按照预期继续运行。仅监测或测试不能确保无菌性。
2.3 Quality Assurance is particularly important, and
manufacture of sterile products must strictly follow carefully
established and validated methods of manufacture and control.
A Contamination Control Strategy (CCS) should be
implemented across the facility in order to define all critical
摘要：
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EUGMP附录1无菌产品生产-2020版（中英文对照）Annex1:ManufactureofSterileProductsEUGMP附录1无菌产品生产-2020版1Scope范围Themanufactureofsterileproductscoversawiderangeofsterileproducttypes(activesubstance,sterileexcipient,primarypackagingmaterialandfinisheddosageform),packedsizes(singleunittomultipleunits),processes(fromhighlyau...
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作者：冒牌货
分类：专业资料
价格：60质量币
属性：28 页
大小：49.19KB
格式：DOCX
时间：2026-01-07
