发布时间 : 星期二 文章cGMP21CFR210211中英对照 - 图文更新完毕开始阅读3ac4505e02d276a201292ed3
(c) In-process materials shall be tested for identity, strength, quality, and purity as appropriate, and approved or rejected by the quality control unit, during the production process, e.g., at commencement or completion of significant phases or after storage for long periods. (d) Rejected in-process materials shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable. § 211.111 Time limitations on production. When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented. § 211.113 Control of microbiological contamination. (c)过程物料应当根据适合程度检测鉴别、剂量、质量和纯度，并由质量部门在生产过程中，比如开始或完成重要步骤时或在长期储存以后，确定批准或拒绝使用。 (d)不合格的中间体，在隔离系统下标识及控制，防止其在生产或加工操作中使用。 211?111生产时间限制 在适当时候，制定完成每一生产阶段的时间限制，保证药品质量。制定的时间限制产生偏差时，如这些偏差不损害药品质量，是可以接受的。这些偏差应有文字文件证明是正当的。 211?113微生物污染的控制 (a)制订和遵循预防非无菌药品有害微生物(a) Appropriate written procedures, designed to prevent objectionable microorganisms in drug 的适当程序。 products not required to be sterile, shall be established and followed. (b) Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of any sterilization process. § 211.115 Reprocessing. (b)制订和遵循预防无菌药品微生物污染的适当程序。这些程序应包括所有灭菌过程的验证。 211?115返工 (a) Written procedures shall be established and (a)应建立并执行书面程序，有关不符合标followed prescribing a system for reprocessing 准或质量标准的批的返工处理的系统，所采batches that do not conform to standards or specifications and the steps to be taken to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics. (b) Reprocessing shall not be performed without the review and approval of the quality control unit. 取的步骤以确保返工的批次符合所有已经建立的标准、质量标准和性质。 (b)没有质量控制部门审核与批准，不许进行返工。 Subpart G-Packaging and Labeling Control G.包装和标签控制 § 211.122 Materials examination and usage criteria. (a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials; such written procedures shall be followed. Labeling and packaging materials shall be representatively sampled, and examined or tested upon receipt and before use in packaging or labeling of a drug product. (b) Any labeling or packaging materials meeting appropriate written specifications may be approved and released for use. Any labeling or packaging materials that do not meet such specifications shall be rejected to prevent their use in operations for which they are unsuitable. (c) Records shall be maintained for each shipment received of each different labeling and packaging material indicating receipt, examination or testing, and whether accepted or rejected. (d) Labels and other labeling materials for each different drug product, strength, dosage form, or quantity of contents shall be stored separately with suitable identification. Access to the storage area shall be limited to authorized personnel. 211?122材料的检查和使用标准 (a)制订详细标签和包装材料的接收、鉴别、贮存、搬运、取样、检验的程序，并遵循这些成文程序。在接收、用于药品包装和贴标签前，有代表性地对其取样与检查。 (b)只有符合成文规格标准的标签和包装材料，方可批准发放使用。不符合规格者，不得用于生产。 (c)收到每次发货的每个不同的标签和包装材料应保留记录，记录应表明接收、检查或检测，以及是否接收或拒收。 (d)用于不同药品、规格、剂型及成份数量的标签和包装材料应分别贮存，并挂上适当标识，只限经核准人员接近贮存地区。 (e) Obsolete and outdated labels, labeling, and other packaging materials shall be destroyed. (e)作废和过时的标签、标示材料及其他包(f) Use of gang printing of labeling for different drug products or different strengths or net contents of the same drug product, is prohibited unless the labeling from gang-printed sheets is adequately differentiated by size, shape, or color. (g) If cut labeling is used, packaging and labeling operations shall include one of the following special control procedures: 装材料应销毁。 (f)不同产品或规格或净含量时使用联合印刷是禁止的，除非联合印刷页上的贴签得到足够的区别，比如大小、形状或颜色。 (g)如果使用切割标签，在包装和标签时，至少有一项如下的专门的控制过程： (1) Dedication of labeling and packaging lines (1) 不同产品各个剂量应有专用贴签和包to each different strength of each different drug 装线。 product. (2) 使用适当的电子的或电子机械的设备(2) Use of appropriate electronic or 来100%的检查贴签过程或完成操作后的标electromechanical equipment to conduct a 100- 签正确性。 percent examination for correct labeling during or after completion of finishing operations; or 或 (3) Use of visual inspection to conduct a 100- percent examination for correct labeling during or after completion of finishing operations for hand- applied labeling. Such examination shall be performed by one person and independently verified by a second person. (h) Printing devices on, or associated with, manufacturing lines used to imprint labeling upon the drug product unit label or case shall be monitored to assure that all imprinting conforms to the print specified in the batch production record. [43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41353, Aug. 3, 1993] (3) 使用目检来100%检查手工包装的贴签过程或完成操作后的标签正确性。这个检查应由一人执行，并有另外一人独立核实。 (h) 打印设备，或标签批号打印与产品生产线在一起或有联系时，应监控以确保所有的批号打印与产品批记录一致。 211?125标签的发放 § 211.125 Labeling issuance. (a) Strict control shall be exercised over labeling issued for use in drug product labeling (a)严格控制用于药品的标签。 operations. (b) Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production records. (c) Procedures shall be utilized to reconcile the quantities of labeling issued, used, and returned, and shall require evaluation of discrepancies found between the quantity of drug product finished and the quantity of labeling issued when such discrepancies are outside narrow preset limits based on historical operating data. Such discrepancies shall be investigated in accordance with § 211.192. Labeling reconciliation is waived for cut or roll labeling if a 100-percent examination for correct labeling is performed in accordance with § 211.122(g)(2). (d) All excess labeling bearing lot or control numbers shall be destroyed. (e) Returned labeling shall be maintained and stored in a manner to prevent mixups and provide proper identification. (f) Procedures shall be written describing in sufficient detail the control procedures employed for the issuance of labeling; such written procedures shall be followed. [43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41345, Aug. 3, 1993] (b)已发放的一批标签材料，须认真检查其同一性，应与一批或单批生产记录中说明的标签一致。 (c)核对发放的，已使用的及退回的标签，若发现成品数量与发出的标签数量不符，差额超出根据先前历史水平定下的数量范围，则需对这些偏差作出评估，按照211?192要求调查原因。 如果按照211.122(G)(2)执行的100%的贴签正确性检查，则切割或滚动贴签的平衡可以不做。 (d)印有批号或控制号的剩余标签，应全部销毁。 (e)退回的标签，如保留应加上证明标志贮存，防止混淆。 (f)制订发放标签的详细控制程序，并遵循执行。 § 211.130 Packaging and labeling operations. There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products; such written procedures shall be followed. These procedures shall incorporate 211?130包装和贴签操作 设计保证标签、标示及包装材料正确用于药品的程序，并遵循。这些程序结合下列特征：