欧盟GMP附录一无菌产品生产 2020版（中英文对照版）

VIP免费

3.0 大傻蛋 2026-06-30 4 1.92MB 90 页 150质量币

侵权投诉

Annex 1 : Manufacture of Sterile Products

Document map

Section Number

General overview

Scope

Includes additional areas (other than sterile products) where the

general principles of the annex can be applied.

Principle

General principles as applied to the manufacture of sterile

products.

Pharmaceutical Quality

Highlights the specific requirements of the PQS when applied

System (PQS)

to sterile products.

Premises

General guidance regarding the specific needs for premises

design and also guidance on the qualification of premises

including the use of Barrier Technology.

Equipment

General guidance on the design and operation of equipment.

Utilities

Guidance with regards to the special requirements of utilities

such as water, gas and vacuum.

Personnel

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 approaches 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.

9. Viable and non-viable

environmental and process

monitoring

10. Quality control (QC)

11. Glossary

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 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.

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。

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 control

points and assess the effectiveness of all the controls (design, procedural, technical and organisational)

and monitoring measures employed to manage risks associated with contamination. The CCS should

be actively updated and should drive continuous improvement of the manufacturing and control

methods.

质量保证尤为重要，无菌产品的生产必须严格遵循精心建立，并经过验证的生产和控制方法。

污染控制策略（CCS）应在整个厂房设施内得到实施以确定出所有关键点并评估用于管理污染

相关风险的所有控制方式（设计，规程上的，技术和组织层面）和监测措施的有效性。应积极

更新 CCS，CCS 应促使生产和控制方法的持续改进。

2.4 Contamination control and steps taken to minimize the risk of contamination from microbial and

particulate sources are a series of successively linked events and measures. These are typically

assessed, controlled and monitored individually but their collective effectiveness should be considered

altogether.

文档加载中……请稍候！
如果长时间未打开，您也可以点击刷新试试。

下载文档到电脑，查找使用更方便

立即下载 VIP免费下载

标签： #GMP #无菌 #中英文对

摘要：

Annex1:ManufactureofSterileProductsDocumentmapSectionNumberGeneraloverview1.ScopeIncludesadditionalareas(otherthansterileproducts)wherethegeneralprinciplesoftheannexcanbeapplied.2.PrincipleGeneralprinciplesasappliedtothemanufactureofsterileproducts.3.PharmaceuticalQualityHighlightsthespecificrequire...

展开>> 收起<<

欧盟GMP附录一无菌产品生产 2020版（中英文对照版）.pdf

共90页,预览50页

还剩页未读，继续阅读

声明：如果您的权利被侵害，请联系我们的进行举报。

欧盟GMP附录一无菌产品生产 2020版（中英文对照版）

相关推荐

相关内容

热门标签

举报选择:

欧盟GMP附录一 无菌产品生产 2020版（中英文对照版）

相关推荐

相关内容

热门标签

举报选择:

欧盟GMP附录一无菌产品生产 2020版（中英文对照版）