欧盟GMP附录一 无菌产品生产 2020版_中英文对照版_
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Annex 1 : Manufacture of Sterile Products
Document map
Section Number
General overview
1. Scope 2. Principle
Includes additional areas (other than sterile products) where the general principles of the annex can be applied.
4. Premises 5. Equipment
General guidance regarding the specific needs for premises design and also guidance on the qualification of premises including the use of Barrier Technology.
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。
9. Viable and non-viable environmental and process monitoring
This section differs from guidance given in section 4 in that the guidance here applies to ongoing routine monitoring with regards to the design of systems and setting of action limits alert levels and reviewing trend data.
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。
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。
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：
Explanation of specific terminology.
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。
10. Quality control (QC) 11. Glossary
The section also gives guidance on the requirements of Aseptic Process Simulation (APS).
Gives guidance on some of the specific Quality Control requirements relating to sterile products.
Guidance on the requirements for specific training, knowledge and skills. Also gives guidance to the qualification of personnel.
8. Production and specific technologies
Discusses the appቤተ መጻሕፍቲ ባይዱoaches to be taken with regards to aseptic and terminal sterilization processes. Discusses approaches to sterilization of products, equipment and packaging components. Also discusses different technologies such as lyophilization and Form-Fill-Seal where specific requirements apply.
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
General principles as applied to the manufacture of sterile products.
3. Pharmaceutical Quality System (PQS)
Highlights the specific requirements of the PQS when applied to sterile products.
General guidance on the design and operation of equipment.
6. Utilities 7. Personnel
Guidance with regards to the special requirements of utilities such as water, gas and vacuum.
Document map
Section Number
General overview
1. Scope 2. Principle
Includes additional areas (other than sterile products) where the general principles of the annex can be applied.
4. Premises 5. Equipment
General guidance regarding the specific needs for premises design and also guidance on the qualification of premises including the use of Barrier Technology.
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。
9. Viable and non-viable environmental and process monitoring
This section differs from guidance given in section 4 in that the guidance here applies to ongoing routine monitoring with regards to the design of systems and setting of action limits alert levels and reviewing trend data.
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。
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。
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：
Explanation of specific terminology.
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。
10. Quality control (QC) 11. Glossary
The section also gives guidance on the requirements of Aseptic Process Simulation (APS).
Gives guidance on some of the specific Quality Control requirements relating to sterile products.
Guidance on the requirements for specific training, knowledge and skills. Also gives guidance to the qualification of personnel.
8. Production and specific technologies
Discusses the appቤተ መጻሕፍቲ ባይዱoaches to be taken with regards to aseptic and terminal sterilization processes. Discusses approaches to sterilization of products, equipment and packaging components. Also discusses different technologies such as lyophilization and Form-Fill-Seal where specific requirements apply.
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
General principles as applied to the manufacture of sterile products.
3. Pharmaceutical Quality System (PQS)
Highlights the specific requirements of the PQS when applied to sterile products.
General guidance on the design and operation of equipment.
6. Utilities 7. Personnel
Guidance with regards to the special requirements of utilities such as water, gas and vacuum.