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Section Number

章節(jié)

General overview

概述

1. Scope

范圍

Includes additional areas (other than sterile products) where the general principles of the annex can be applied.

包括可適用本附錄一般原則的其他領(lǐng)域（其他非無(wú)菌產(chǎn)品外）。

2. Principle

原則

General principles as applied to the manufacture of sterile products.

適用于無(wú)菌產(chǎn)品生產(chǎn)的一般原則。

3. Pharmaceutical Quality System (PQS)

藥品質(zhì)量體系（PQS）

Highlights the specific requirements of the PQS when applied to sterile products.

重點(diǎn)介紹 PQS 在應(yīng)用于無(wú)菌產(chǎn)品時(shí)的具體要求。

4. Premises

廠房

General guidance regarding the specific needs for premises design and also guidance on the qualification of  premises including the use of Barrier Technology.

關(guān)于廠房設(shè)計(jì)的具體要求，以及關(guān)于廠房確認(rèn)的指導(dǎo)，包括使用隔離技術(shù)。

5. Equipment

設(shè)備

General guidance on the design and operation of equipment.

關(guān)于設(shè)備設(shè)計(jì)和操作的一般指導(dǎo)。

6. Utilities

公用系統(tǒng)

Guidance regarding the special requirements of utilities such as water, gas and vacuum.

有關(guān)水，氣和真空等公用系統(tǒng)特定要求的指南。

7. Personnel

人員

Guidance on the requirements for specific training, knowledge and skills. Also gives guidance regarding the  qualification of personnel.

關(guān)于特定培訓(xùn)，知識(shí)和技能要求的指導(dǎo)。還就人員確認(rèn)提供了指導(dǎo)。

8. Production and specific technologies

生產(chǎn)和特定技術(shù)

Guidance on the approaches to be taken regarding aseptic and terminal sterilization processes. Guidance on the  approaches to sterilization of products, equipment and  packaging components. Also guidance on different  technologies such as lyophilization and  Form-Fill-Seal where specific requirements apply.

關(guān)于無(wú)菌和終末滅菌工藝應(yīng)采取的方法的指南。關(guān)于產(chǎn)品、設(shè)備和包裝部件滅菌方法的指南。還不同技術(shù)，如凍干和成型-灌裝-密封，的特定要求提供指導(dǎo)。

9. Environmental and process monitoring

環(huán)境和過(guò)程監(jiān)測(cè)

This section differs from guidance given in section 4 in that the guidance here applies to ongoing routine monitoring  regarding 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 Simulations  (APS).

本節(jié)與第 4 節(jié)中給出的指導(dǎo)不同，因?yàn)榇颂幍闹改线m用于有關(guān)持續(xù)日常監(jiān)測(cè)的系統(tǒng)設(shè)計(jì)和行動(dòng)限/警戒限設(shè)置以及趨勢(shì)數(shù)據(jù)回顧。 本節(jié)還就無(wú)菌工藝模擬（APS）的要求提供了指導(dǎo)。

10. Quality control (QC)

質(zhì)量控制（QC）

Guidance on some of the specific Quality Control requirements relating to sterile products.

關(guān)于無(wú)菌產(chǎn)品的一些具體質(zhì)量控制要求的指南。

11. Glossary

術(shù)語(yǔ)

Explanation of specific terminology.

具體術(shù)語(yǔ)的解釋。