欧盟GMP（中英文对照）

欧盟GMP（中英⽂对照）

（The words that are in the green background are new standards）

(绿⾊背景下的内容为新标准)

ANNEX 1

MANUFACTURE OF STERILE MEDICINAL PRODUCTS

附录1 ⽆菌医药产品的⽣产

Principle总则

The manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological

contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the

personnel involved. Quality Assurance is particularly important, and this type of manufacture must strictly follow carefully

established and validated methods of preparation and procedure. Sole reliance for sterility or other quality aspects must not

be placed on any terminal process or finished product test.

⽆菌药品的⽣产，必须符合⼀些特殊的要求，以防⽌微⽣物、微粒和热源的污染。这很⼤程度上依赖与⼯作⼈员的技术⽔平、

培训和⼯作态度。在这⽅⾯质量保证显得特别重要，这种类型的⽣产，必须严格按照完善的和经过验证的⽣产⽅法和⼯作程

序。仅靠产品的最终灭菌和某⼀⽅⾯的质量控制是不允许的。

Note:

This guidance does not lay down detailed methods for determining the microbiological and particulate cleanliness of air,

surfaces etc. Reference should be made to other documents such as the EN/ISO Standards.

注：本规范没有详述测定空⽓、表⾯等微⽣物和微粒洁净度的详细⽅法，请参阅EN/ISO中相关标准。

General 概要

1. The manufacture of sterile products should be carried out in clean areas entry to which should be through airlocks for

personnel and/or for equipment and materials. Clean areas should be maintained to an appropriate cleanliness standard and

supplied with air which has passed through filters of an appropriate efficiency.

⽆菌产品的⽣产要在洁净区域内进⾏，进⼊这些区域内的⼈员、设备和物料，必须通过缓冲间。洁净区必须保持⼀定的洁净级

别，空⽓必须通过规定的过滤器。

2. The various operations of component preparation, product preparation and filling should be carried out in separate areas

within the clean area. Manufacturing operations are divided into two categories; firstly those where the product is terminally

sterilised, and secondly those which are conducted aseptically at some or all stages.

各种原料的准备、产品的准备和灌装，必须在洁净区的不同区域进⾏，⽣产操作分为两类，⼀是最终灭菌型，⼆是部分过程或

全过程的⽆菌操作。

3. Clean areas for the manufacture of sterile products are classified according to the required characteristics of the

environment. Each manufacturing operation requires an appropriate environmental cleanliness level in the operational state

in order to minimise the risks of particulate or microbial contamination of the product or materials being handled.

⽆菌⽣产的洁净区，按照产品对环境的要求分级。每⼀步⽣产操作，其操作状态对环境有相应的洁净级别的要求，以降低对物

料或产品造成微粒或微⽣物的污染的风险。

In order to meet “in operation” conditions these areas should be designed to reach certain specified air-cleanliness levels in

the “at rest” occupancy state. The “at-rest” state is the condition where the installation is installed and operating, complete

with production equipment but with no operating personnel present. The “in operation” state is the condition where the

installation is functioning in the defined operating mode with the specified number of personnel working.

为达到“动态”的条件，这些区域在设计上要达到特定的“静态”的空⽓洁净度洁净标准。“静态”指设备已经安装并运⾏，⽣产设备

就位但是没有操作⼈员在场。“动态”是指在设备正常运转状态下和有规定的⼯作⼈员在场的情况下。

The “in operation” and “at rest” states should be defined for each clean room or suite of cleanrooms.

每个或每套房间都要分别进⾏“静态”和“动态”的确定。For the manufacture of sterile medicinal products 4 grades can be distinguished.

⽆菌产品的⽣产有4个环境级别：

Grade A: The local zone for high risk operations, e.g. filling zone, stopper bowls, open ampoules and vials, making aseptic

connections. Normally such conditions are provided by a laminar air flow work station. Laminar air flow systems should

provide a homogeneous air speed in a range of 0.36 – 0.54 m/s (guidance value) at the working position in open clean room

applications. The maintenance of laminarity should be demonstrated and validated.

A uni-directional air flow and lower velocities may be used in closed isolators and glove boxes.

A级：⽤于⾼风险的⽣产操作，如灌装区、加盖区、容器开⼝区、和进⾏⽆菌连接的地⽅。通常这种情况是带有层流罩的⼯作

站。在开放的洁净区内的⼯作站上，层流罩应该能产⽣风速为0.36 –0.54⽶/秒的均匀⽓流。层流罩的维护，必须有充分的证明

和经过验证。

密封隔离器和⼿套箱内，可采⽤单向低速⽓流。

Grade B: For aseptic preparation and filling, this is the background environment for the grade A zone.

B级：对于⽆菌制备和灌装，B级区域是A级区域的背景环境。

Grade C and D: Clean areas for carrying out less critical stages in the manufacture of sterile products.

C级和D级：⽆菌产品⾮关键⽣产步骤的洁净区。

Clean room and clean air device classification 洁净室及空⽓洁净装置分级4. Clean rooms and clean air devices should be

classified in accordance with EN ISO 14644-1. Classification should be clearly differentiated from operational process

environmental monitoring. The maximum permitted airborne particle concentration for each grade is given in the following

table.

洁净室及空⽓洁净装置分级与EN ISO14644-1要求⼀致。应按照操作过程的环境监控数据明确区分级区。下表列出了各个级别所允许的最⼤数量空⽓尘埃粒⼦数⽬。

5. For classification purposes in Grade A zones, a minimum sample volume of 1m3 should be taken per sample location. For