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The 25 SOPs provisions under Part 211 include:
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第211部分中25個(gè)SOP條款包括
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Section211.22(d)-Responsibilities and procedures of the quality control unit;
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第211.22(d)- 質(zhì)量控制部門(mén)的職責和程序
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Section211.56(b)-Sanitation procedures
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第211.56(b) - 消毒程序
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Section211.56(c)-Use of suitable rodenticides, insecticides, fungicides, sanitizing agents;
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第211.56(c)---使用適當殺蟲(chóng)劑、滅鼠藥、殺真菌劑、消毒劑
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Section211.67(b)-Cleaning and maintenance of equipment;
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第211.67(b)----設備的清潔和維護
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Section211.68(a)-Proper performance of automatic, mechanical, and electronic equipment;
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第211.68(a)----自動(dòng)化、機械化和電子設備具備適當性能
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Section211.80(a)-Receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers or closures;
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第211.80(a)---部件和藥品容器密閉材料的接收、鑒別、存貯、處置、取樣、測試和批準或拒收
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Section211.94(d)-Standards or specifications, methods of testing, and methods of cleaning, sterilizing, and processing to remove pyrogenic properties for drug product containers and closures;
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第211.80(d)---藥品容器密閉材料的規格或質(zhì)量標準、檢驗方法、清潔方法、滅菌方法及清除熱原
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Section211.100(a)-Production and process control;
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第211.100(a)---生產(chǎn)和工藝控制
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Section211.110(a)-Sampling and testing of in-process materials and drug products;
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第211.110(a)---中控和成品取樣和檢測
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Section211.113(a)-Prevention of objectionable microorganisms in drug products not required to be sterile;
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第211.113(a)----非無(wú)菌藥品中防止有害微生物
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Section211.113(b)-Prevention of microbiological contamination of drug product spurporting to be sterile, including validation of any sterilization process;
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第211.113(b)---無(wú)菌藥品中防止微生物污染,包括所有無(wú)菌工藝的驗證
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Section211.115(a)-System for reprocessing batches that do not conform to standards or specifications, to insure that reprocessed batches conform with all established standards, specifications, and characteristics;
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第211.115(a)----不符合質(zhì)量標準的批準的返工管理,以保證返工后批次符合所有既定標準、質(zhì)量規格和特性
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Section211.122(a)-Receipt, identification, storage, handling, sampling, examination and/or testing of labeling and packaging materials;
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第211.122(a)---標簽和包裝材料的接收、鑒別、存貯、處置、取樣、檢查和/或檢測
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Section211.125(f)-Control procedures for the issuance of labeling;
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第211.125(f)---標簽發(fā)放控制程序
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Section211.130-Packaging and label operations, prevention of mixup and cross contamination, identification and handling of filed drug product containers that are set aside and held in unlabeled condition, and identification of the drug product with a lot or control number that permits determination of the history of the manufacture and control of the batch;
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第211.130---包裝和貼標操作、防止混淆和交叉污染、鑒別和處置已印制但棄置且無(wú)標識的藥品包材、采用批號或控制號鑒別藥品,使其可追溯生產(chǎn)和批控制歷史
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Section211.142-Warehousing;
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第211.142----倉庫管理
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Section211.150-Distribution of drug products;
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第211.150----藥品分銷(xiāo)
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Section211.160-Laboratory controls;
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第211.160----實(shí)驗室控制
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Section211.165(c)-Testing and release for distribution;
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第211.165(c)-----檢測和放行用于銷(xiāo)售
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Section211.166(a)-Stability testing;
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第211.166(a)---穩定性測試
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Section211.167-Special testing requirements;
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第211.167----特殊檢測要求
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Section211.180(f)-Notification of responsible officials of investigations, recalls,reports of inspectional observations, and any regulatory actions relating to good manufacturing practice;
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第211.180(f)----將調查、召回、檢查缺陷和所有與GMP相關(guān)的法規行動(dòng)通知相關(guān)官方
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Section211.198(a)-Written and oral complaint procedures, including quality involving specifications failures, and serious and unexpected adverse drug experiences;
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