ANNEX 17 Parametric Release (July 2001) ACU 20050905

ANNEX 17 附件17

Parametric Release 参数放行

Table of Contents目录

1. Principle 原则

2. Parametric Release参数放行

3. Parametric Release for sterile products. 无菌产品的参数放行

4. Glossary术语

1. Principle原则

1.1 The definition of Parametric Release used in this Annex is based on that proposed by the European Organization for Quality: " A system of release that gives the assurance that the product is of the intended quality based on information collected during the manufacturing process and on the compliance with specific GMP requirements related to Parametric Release."

本附件中参数放行的定义，是根据欧洲质量组织提出的：“是根据生产过程中收集的信息和与GMP 中与参数放行相关的要求相符合，保证产品达到预期的质量的放行系统”。

1.2. Parametric release should comply with the basic requirements of GMP, with applicable annexes and the following guidelines.

参数放行要符合GMP的基本要求，符合其他相关的附件和以下原则。

2. Parametric release参数放行

2.1. It is recognised that a comprehensive set of in-process tests and controls may provide greater assurance of the finished product meeting specification than finished product testing.

普遍认为，全面的一套过程控制和检验要比最终产品的检验，能够提供最终产品符合标准的更高的保证。

2.2. Parametric release may be authorised for certain specific parameters as an alternative to routine testing of finished products. Authorisation for parametric release should be given, refused or withdrawn jointly by those responsible for assessing products together with the GMP inspectors.

参数放行是把一些特定的参数定义为替代最终产品检验的特定参数。参数放行的授予、拒绝或撤回要由负责产品评估的人和GMP检查人员共同核准。

3. Parametric release for sterile products无菌产品的放行

3.1. This section is only concerned with that part of Parametric Release which deals with the routine release of finished products without carrying out a sterility test. Elimination of the sterility test is only valid on the basis of successful demonstration that predetermined, validated sterilising conditions have been achieved.

本节只涉及进行正常放行不做无菌检查的参数放行部分。

免除无菌检验，是基于整个过程能有效地证明达到预先设定的和经过验证的灭菌条件。

3.2. A sterility test only provides an opportunity to detect a major failure of the sterility assurance system due to statistical limitations of the method.

无菌检验仅是提供由于方法上的统计缺陷所导致的无菌保证系统失效的一个检查方法。

3.3. Parametric Release can be authorised if the data demonstrating correct processing of the batch provides sufficient assurance, on its own, that the process designed and validated to ensure the sterility of the product has been delivered.

只有在有数据表明产品的生产有充分的保证，生产工艺的设计和验证保证产品的无菌性时，参数放行才会被批准。

3.4. At present Parametric release can only be approved for products terminally sterilized in their