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The 25 SOPs provisions under Part 211 include:
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第211部分中25个SOP条款包括
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Section211.22(d)-Responsibilities and procedures of the quality control unit;
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第211.22(d)- 质量控制部门的职责和程序
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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)---使用适当杀虫剂、灭鼠药、杀真菌剂、消毒剂
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Section211.67(b)-Cleaning and maintenance of equipment;
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第211.67(b)----设备的清洁和维护
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Section211.68(a)-Proper performance of automatic, mechanical, and electronic equipment;
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第211.68(a)----自动化、机械化和电子设备具备适当性能
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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)---部件和药品容器密闭材料的接收、鉴别、存贮、处置、取样、测试和批准或拒收
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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)---药品容器密闭材料的规格或质量标准、检验方法、清洁方法、灭菌方法及清除热原
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Section211.100(a)-Production and process control;
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第211.100(a)---生产和工艺控制
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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)---中控和成品取样和检测
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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)----非无菌药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)---无菌药品中防止微生物污染,包括所有无菌工艺的验证
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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)----不符合质量标准的批准的返工管理,以保证返工后批次符合所有既定标准、质量规格和特性
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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)---标签和包装材料的接收、鉴别、存贮、处置、取样、检查和/或检测
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Section211.125(f)-Control procedures for the issuance of labeling;
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第211.125(f)---标签发放控制程序
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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---包装和贴标操作、防止混淆和交叉污染、鉴别和处置已印制但弃置且无标识的药品包材、采用批号或控制号鉴别药品,使其可追溯生产和批控制历史
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Section211.142-Warehousing;
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第211.142----仓库管理
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Section211.150-Distribution of drug products;
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第211.150----药品分销
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Section211.160-Laboratory controls;
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第211.160----实验室控制
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Section211.165(c)-Testing and release for distribution;
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第211.165(c)-----检测和放行用于销售
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Section211.166(a)-Stability testing;
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第211.166(a)---稳定性测试
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Section211.167-Special testing requirements;
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第211.167----特殊检测要求
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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)----将调查、召回、检查缺陷和所有与GMP相关的法规行动通知相关官方
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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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