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Section Number 章節(jié) |
General overview 概述 |
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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域（其他非無菌產(chǎn)品外）。 |
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2. Principle 原則 |
General principles as applied to the manufacture of sterile products. 適用于無菌產(chǎn)品生產(chǎn)的一般原則。 |
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3. Pharmaceutical Quality System (PQS) 藥品質量體系（PQS） |
Highlights the specific requirements of the PQS when applied to sterile products. 重點介紹 PQS 在應用于無菌產(chǎn)品時的具體要求。 |
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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. 關于廠房設計的具體要求，以及關于廠房確認的指導，包括使用隔離技術。 |
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5. Equipment 設備 |
General guidance on the design and operation of equipment. 關于設備設計和操作的一般指導。 |
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6. Utilities 公用系統(tǒng) |
Guidance regarding the special requirements of utilities such as water, gas and vacuum. 有關水，氣和真空等公用系統(tǒng)特定要求的指南。 |
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7. Personnel 人員 |
Guidance on the requirements for specific training, knowledge and skills. Also gives guidance regarding the qualification of personnel. 關于特定培訓，知識和技能要求的指導。還就人員確認提供了指導。 |
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8. Production and specific technologies 生產(chǎn)和特定技術 |
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. 關于無菌和終末滅菌工藝應采取的方法的指南。關于產(chǎn)品、設備和包裝部件滅菌方法的指南。還不同技術，如凍干和成型-灌裝-密封，的特定要求提供指導。 |
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9. Environmental and process monitoring 環(huán)境和過程監(jiān)測 |
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)中給出的指導不同，因為此處的指南適用于有關持續(xù)日常監(jiān)測的系統(tǒng)設計和行動限/警戒限設置以及趨勢數(shù)據(jù)回顧。 本節(jié)還就無菌工藝模擬（APS）的要求提供了指導。 |
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10. Quality control (QC) 質量控制（QC） |
Guidance on some of the specific Quality Control requirements relating to sterile products. 關于無菌產(chǎn)品的一些具體質量控制要求的指南。 |
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11. Glossary 術語 |
Explanation of specific terminology. 具體術語的解釋。 |
Deadline for coming into operation:
生效時間：
25 August 2023 : one year from the date of publication in Eudralex Volume 4
2023 年 8 月 25 日：發(fā)布之日起一年后生效（除8.123節(jié)外）
25 August 2024 : two years from the date of publication in Eudralex Volume 4 for point 8.123
2024 年 8 月 25 日：發(fā)布之日起兩年后第 8.123 節(jié)生效
解讀：
關于隔離器的背景環(huán)境：對于開放式隔離器，要求背景環(huán)境至少達到C級，不再允許D級背景。
4.20 ...The background environment for open isolators should generally correspond to a minimum of grade C. The background for closed isolators should correspond to a minimum of grade D. The decision on the background classification should be based on risk assessment and justified in the CCS.
開放式隔離器的背景環(huán)境通常應符合C級的最低要求。密閉式隔離器的背景應與最低 D 級相對應。關于背景級別的決定應以風險評估為基礎，并在CCS中說明理由。
要求A級（RABS）使用殺孢子劑：
4.22 ... For RABS：The sporicidal disinfection should include the routine application of a sporicidal agent using a method that has been validated and demonstrated to robustly include all areas of the interior surfaces and ensure a suitable environment for aseptic processing.
對于RABS：應包括殺孢劑的日常使用，使用經(jīng)驗證和證明可有效涵蓋RABS內表面的所有區(qū)域，并確保用于無菌處理的合適環(huán)境的方法。
對于潔凈室分級，對于A級動態(tài)、靜態(tài)以及B級靜態(tài)，正式確定對5 µm粒子不做規(guī)定，對于D級動態(tài)粒子標準，文件未設定標準，但要求制造商應根據(jù)風險評估和日常數(shù)據(jù)(如適用)建立D級的動態(tài)標準。
來源：GMP辦公室學習平臺
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