发布时间 : 星期六 文章cGMP21CFR210211中英对照 - 图文更新完毕开始阅读3ac4505e02d276a201292ed3
as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order. § 211.184 Component, drug product container, closure, and labeling records. These records shall include the following: (a) The identity and quantity of each shipment of each lot of components, drug product containers, closures, and labeling; the name of the supplier; the supplier's lot number(s) if known; the receiving code as specified in § 211.80; and the date of receipt. The name and location of the prime manufacturer, if different from the supplier, shall be listed if known. (b) The results of any test or examination performed (including those performed as required by § 211.82(a), § 211.84(d), or §211.122(a)) and the conclusions derived therefrom. (c) An individual inventory record of each component, drug product container, and closure and, for each component, a reconciliation of the use of each lot of such component. The inventory record shall contain sufficient information to allow determination of any batch or lot of drug product associated with 主要设备的清洁、保养（常规保养，如润滑、调整等除外）和使用文字记录，包括在单独的设备记录内，此记录列有日期、时间、产品和加工批号等内容。若设备专用于生产一种药品，药品批号（单批或整批）按号码排列，且按顺序号生产，那么，不要求单独的设备记录。使用专用设备时，其清洁、保养和使用记录是批生产记录的一部分。清洁和保养的操作人员和复核人员，应在记录上填写日期、签名和填写操作记录，证明该项工作已做过。记录应按年月顺序进行。 211?184成份、药品容器、密封件及标签记录 这些记录包括如下内容： (a)每次至货的每批成份、药品容器、密封件和标签的鉴别与数量，供应商名称；供应商的批号（如知道）、按21?80指定的接收代码、接收日期。原始生产商的名称和地址，若与供应商不同，若知道应列出。 (b)任何检验结果（包括按211?82（a）211?84(d)或211?122（a）的要求进行的检验结果）和从那里得到的结论。 (c)每个成份、药品容器、密封件的单独存货记录和每批使用的成份核对表（对各成份来说）。此存货记录应有使用各成份、药品容器和密封件的各批（整批或小批）药品的详细资料。 the use of each component, drug product container, and closure. (d) Documentation of the examination and review of labels and labeling for conformity with (d)按211?122（c）和211?130（c）制订的established specifications in accord with §§ 规定，检查或复查标签和贴标签所提供的文211.122(c) and 211.130(c). 件。 (e) The disposition of rejected components, drug product containers, closure, and labeling. (e)不合格成份、药品容器、密封件和标签的处理。 § 211.186 Master production and control records. 211?186主要生产和控制的记录 (a) To assure uniformity from batch to batch, master production and control records for each (a)保障批与批间的一致性，准备各批药品drug product, including each batch size thereof, 的主要生产和控制记录（包括各批的量），shall be prepared, dated, and signed (full 由一人填写日期和签名（手写、签全名）。signature, handwritten) by one person and independently checked, dated, and signed by a 由另一个单独核实，填写日期和签名。此second person. The preparation of master 主要生产和控制记录的准备，应成文字程production and control records shall be 序加以说明，并遵循。 described in a written procedure and such written procedure shall be followed. (b) Master production and control records shall include: (b)主要生产和控制记录包括： (1) The name and strength of the product and (1)产品名称、规格和剂型的说明。 a description of the dosage form; (2) The name and weight or measure of each active ingredient per dosage unit or per unit of (2)每剂量单位或每重量单位中各活性成份weight or measure of the drug product, and a statement of the total weight or measure of any 的名称、重量或容量；任何剂量单位的总重dosage unit; 量或容量。 (3) A complete list of components designated by names or codes sufficiently specific to indicate any special quality characteristic; (4) An accurate statement of the weight or measure of each component, using the same weight system (metric, avoirdupois, or apothecary) for each component. Reasonable (3)一份完整的、以名称或代码表示的成份列表，能充分显示特定的质量特性。 (4)准确描述各成份的重量或容量，使用相同计量系统（公制、常衡或药衡制）。合理