identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed. (b) Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination. 件的签收、鉴定、贮存、装运取样、检验和批准或拒收程序，并遵循。 (b)成份、药品容器和密封件应专人管理和在防止污染的环境下贮存。 (c) Bagged or boxed components of drug (c)药品容器的包装袋或包装箱或密封件应product containers, or closures shall be stored 离地面放置保持适当间隔，以便清洁和检off the floor and suitably spaced to permit 查。 cleaning and inspection. (d) Each container or grouping of containers for components or drug product containers, or closures shall be identified with a distinctive code for each lot in each shipment received. This code shall be used in recording the disposition of each lot. Each lot shall be appropriately identified as to its status (i.e., quarantined, approved, or rejected). § 211.82 Receipt and storage of untested components, drug product containers, and closures. (a) Upon receipt and before acceptance, each container or grouping of containers of components, drug product containers, and closures shall be examined visually for appropriate labeling as to contents, container damage or broken seals, and contamination. (b) Components, drug product containers, and closures shall be stored under quarantine until they have been tested or examined, as appropriate, and released. Storage within the area shall conform to the requirements of §211.80. § 211.84 Testing and approval or rejection of components, drug product containers, (d)用明显批号代码对已接收的每次到货的成份、药品容器或密封件加以区别。此批号代码用于记录每批货的处理。每批货按其状态应有适当标识，如待验、批准或拒收。 211?82未检验的成份、药品容器和密封件的接收与贮存 (a)接收时和验收前，对每个或编组的成份容器、药品容器和密封件进行目检，检查标签与内容物是否一致、容器损坏或拆封和污染等情况 (b)成份、药品容器各密封件应隔离贮存，直至经检验为止。合格后，方可发放。在符合211?80要求的地方中贮存。 211?84成份、药品容器和密封件的试验、批准或拒收 and closures. (a)每批成份、药品容器和密封件，在未经(a) Each lot of components, drug product containers, and closures shall be withheld from 质量部门取样、检查合格前，不准使用。检验合格后发放使用。 use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit. (b) Representative samples of each shipment of each lot shall be collected for testing or examination. The number of containers to be sampled, and the amount of material to be taken from each container, shall be based upon appropriate criteria such as statistical criteria for component variability, confidence levels, and degree of precision desired, the past quality history of the supplier, and the quantity needed for analysis and reserve where required by § 211.170. (c) Samples shall be collected in accordance with the following procedures: (1) The containers of components selected shall be cleaned where necessary, by appropriate means. (2) The containers shall be opened, sampled, and resealed in a manner designed to prevent contamination of their contents and contamination of other components, drug product containers, or closures. (3) Sterile equipment and aseptic sampling techniques shall be used when necessary. (4) If it is necessary to sample a component from the top, middle, and bottom of its container, such sample subdivisions shall not be composited for testing. (b)每次到货的每个批号应收集代表性样品用于检测或检查。要取样的包装个数以及每个包装应取的样品量应根据适当标准来定，比如成份分可变程度的统计标准、供应商的信用级别、期望的精密度、供应商以往质量历史、以及按照法规§ 211.170规定的分析和保留的样品及其质量。 (c)收集样品程序： (1)必要时，用适当的方法，清洁选出成份容器； (2)打开容器，取样，重新封口，防止其内容物受污染和其他成分、药品容器或密封件的污染。 (3)必要时，使用灭菌设备和无菌取样技术。 (4)如果需要从容器顶部、中部和底部的成分中取样，这些样品不得混合。 (5) Sample containers shall be identified so that (5)标识样品容器，目的是确定如下资料：the following information can be determined: 被取样的材料名称、批号、被取样的容器，name of the material sampled, the lot number, 取样日期及样品收集人的名字等。 the container from which the sample was taken, the date on which the sample was taken, and the name of the person who collected the sample. (6) Containers from which samples have been taken shall be marked to show that samples have been removed from them. (d) Samples shall be examined and tested as follows: (6)已取样的容器，应作标志，表示样品已取出。 (d)样品检验程序： (1) At least one test shall be conducted to verify (1)一个药品的每个成分，最少做一个特性the identity of each component of a drug 试验。如有专一特性实验就应采用。 product. Specific identity tests, if they exist, shall be used. (2) Each component shall be tested for conformity with all appropriate written specifications for purity, strength, and quality. In lieu of such testing by the manufacturer, a report of analysis may be accepted from the supplier of a component, provided that at least one specific identity test is conducted on such component by the manufacturer, and provided that the manufacturer establishes the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals. (3) Containers and closures shall be tested for conformance with all appropriate written procedures. In lieu of such testing by the manufacturer, a certificate of testing may be accepted from the supplier, provided that at least a visual identification is conducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reliability of the supplier's test results through appropriate validation of the supplier's test results at appropriate intervals. (4) When appropriate, components shall be microscopically examined. (5) Each lot of a component, drug product (2)依照所有成文的规格标准检验每个成份的纯度、含量和质量。假如通过定期验证供应者的试验结果，证明供应商的分析结果正确可靠的基础上，可以接受以供应商提供的分析报告来代替上述试验，但最少要做个成份特性试验。 (3)依照成文规程，检验容器和密封件。假如通过定期验证供应者的试验结果，证明供应商的分析结果正确可靠的基础上，可以接受以供应商提供的分析报告来代替上述试验，但最少做一次目检。 (4)必要时，用显微镜检测成分。 (5)对于易受污物、昆虫或其他外来杂物污container, or closure that is liable to contamination with filth, insect infestation, or other extraneous adulterant shall be examined against established specifications for such contamination. (6) Each lot of a component, drug product container, or closure that is liable to microbiological contamination that is objectionable in view of its intended use shall be subjected to microbiological tests before use. (e) Any lot of components, drug product containers, or closures that meets the appropriate written specifications of identity, strength, quality, and purity and related tests under paragraph (d) of this section may be approved and released for use. Any lot of such material that does not meet such specifications shall be rejected. 染的某一成份、药品容器或密封件，每批应按制订的标准检查，避免污染。 (6)对于易被微生物污染的某一成份、药品容器或密封件，而且对其预计的用途会产生不良影响，则每批在使用前应当做微生物试验。 （e）任何批号的成份、药品容器或密封件，若符合已成文的均一性、效价或含量、质量、纯度等的规格标准和本部分（d）的有关试验，可批准使用。任何批号的上述物料，不符合这些规格，应拒收。 § 211.86 Use of approved components, drug 211?86获准的成份、药品容器和密封件的使product containers, and closures. 用 Components, drug product containers, and closures approved for use shall be rotated so 获准使用的成份、药品容器和密封件，先入that the oldest approved stock is used first. 库者先用。若产生的偏差是暂时的和适当，Deviation from this requirement is permitted if 这种偏差是容许的。 such deviation is temporary and appropriate. § 211.87 Retesting of approved components, drug product containers, and closures. Components, drug product containers, and closures shall be retested or reexamined, as appropriate, for identity, strength, quality, and purity and approved or rejected by the quality control unit in accordance with § 211.84 as necessary, e.g., after storage for long periods or after exposure to air, heat or other conditions that might adversely affect the component, 211?87获准的成份、药品容器和密封件的复检 经质量控制部门批准或拒收的成份、药品容器、密封件，若长期贮存或曝露在空气、热或其他可能对其产生不良影响的环境后，应依照211?84，对均一性、效价或含量、质量、纯度等复检。