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21CFR Part 210&211
evidence of reserve sample deterioration shall be investigated in accordance with 211.192. The results of the examination shall be recorded and maintained with other stability data on the drug product. Reserve samples of compressed medical gases need not be retained. The retention time is as follows:
(1)For a drug product other than those (1)除本部分（b）（2）和（3）中述及的药品外，described in paragraphs (b) (2) and (3) of this 留样保留至药品有效期满后一年。 section, the reserve sample shall be retained for 1 year after the expiration date of the drug product.
(2) For a radioactive drug product, except for (2)对于放射性药品，除放射性试剂盒外，放射nonradioactive reagent kits, the reserve 活性药品的留样： sample shall be retained for:
(i) Three months after the expiration date of the (i) 如果药品的有效期是30天或30天以内，留drug product if the expiration dating period of 样保留至该药品有效期满后三个月，或 the drug product is 30 days or less; or
(ii) Six months after the expiration date of the (ii)如果药品的有效期大于30天，留样保留至该drug product if the expiration dating period of 药品有效期满后六个月。 the drug product is more than 30 days.
(3) For an OTC drug product that is exempt for (3) 根据211?137免除有效期的非处方药，留样bearing an expiration date under 211.137, the 保留至该批药品售出后三年。 reserve sample must be retained for 3 years after the lot or batch of drug product is distributed. [48 FR 13025, Mar. 29, 1983, as amended at 60 FR 4091, Jan. 20, 1995] Sec. 211.173 Laboratory animals.
211.173实验动物
用于检测组份、中间体或或成品的动物，应按适用其预期的用途的方式进行饲养和控制。动物应进行标识，并保留其使用情况的足够的历史记录。
Animals used in testing components, in-process materials, or drug products for compliance with established specifications shall be maintained and controlled in a manner that assures their suitability for their intended use. They shall be identified, and adequate records shall be maintained showing the history of their use. Sec. 211.176 Penicillin contamination.
211.176青霉素污染
If a reasonable possibility exists that a 如果非青霉素药品有可能和青霉素交叉感染，non-penicillin drug product has been exposed 此非青霉素药品应检查是否有青霉素存在。按to cross-contamination with penicillin, the 药品中青霉素污染检测程序（通过相关参考文non-penicillin drug product shall be tested for 献）检验，如检出青霉素，该药品不许销售。the presence of penicillin. Such drug product 文件的复制品可从研究和检测部门（HFD470）shall not be marketed if detectable levels are 药品评价和研究中心、FDA、200C found when tested according to procedures St.Sw.Washington DC 2024,或从联邦注册处specified in `Procedures for Detecting and （1100L St. Nw., Washington, DC2048）得到：
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21CFR Part 210&211
Measuring Penicillin Contamination in Drugs,' which is incorporated by reference. Copies are available from the Division of Research and Testing (HFD-470), Center for Drug Evaluation and Research, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code _of_federal_regulations/ibr_locations.html [43 FR 45077, Sept. 29, 1978, as amended at 47 FR 9396, Mar. 5, 1982; 50 FR 8996, Mar. 6, 1985; 55 FR 11577, Mar. 29, 1990; 66 FR 56035, Nov. 6, 2001; 69 FR 18803, Apr. 9, 2004]
Subpart J--Records and Reports Sec. 211.180 General requirements.
若想获得在NARA上的这个材料的信息，打电话至202-741-6030，或是到网站：
http://www.archives.gov/federal_register/code _of_federal_regulations/ibr_locations.html
J--记录和报告 211.180总体要求
(a) Any production, control, or distribution (a)任何生产、控制或分发记录，须和本部分要record that is required to be maintained in 求一致，特别是与这一批药品有关的记录，需compliance with this part and is specifically 保留至该批药品有效期满后一年以上。对于一associated with a batch of a drug product shall 些符合211?137免除标准的无有效期的非处方be retained for at least 1 year after the 药品，记录保存至该批药品全部分发后三年。 expiration date of the batch or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under 211.137, 3 years after distribution of the batch.
(b) Records shall be maintained for all (b)全部组份，药品容器、密封器及标签记录，components, drug product containers, 保留至有效期满后一年以上。一些符合211?137closures, and labeling for at least 1 year after 免除标准的无有效期的非处方药品，其组份、the expiration date or, in the case of certain 或应用的容器，密封器或是标签的相关记录保OTC drug products lacking expiration dating 存至药品全部分发后三年。 because they meet the criteria for exemption under 211.137, 3 years after distribution of the last lot of drug product incorporating the component or using the container, closure, or labeling.
(c) All records required under this part, or (c)本部分要求的全部记录或它们的复印件，应copies of such records, shall be readily 保存在活动发生地，便于在保存期内官方检查。available for authorized inspection during the 这些检验记录可以作为检查以光电复印或其他retention period at the establishment where the 方法复制。通过计算机或其它电子设备中从另activities described in such records occurred. 一地点快速获取的记录也要符合本段的要求。 These records or copies thereof shall be
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21CFR Part 210&211
subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph.
(d) Records required under this part may be (d)本部分要求的记录，可保留原始记录或真实retained either as original records or as true 复印件，比如光电复印、缩微胶卷、缩微胶片copies such as photocopies, microfilm, 或其他的准确的原始记录复制品。使用的复制microfiche, or other accurate reproductions of 技术，如缩微胶卷，应适合阅读，且复印设备the original records. Where reduction 易得。 techniques, such as microfilming, are used, suitable reader and photocopying equipment shall be readily available.
(e) Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations and shall include provisions for:
(e)本部分中的记录要保留，以便数据可以用来对药品质量进行至少每年一次的评估，从而确定药品质量标准、生产或控制程序的变更需求。制订并执行这些评估程序，包括下列内容：
(1) A review of a representative number of (1)审核一定有代表性数量的批次，无论批准或batches, whether approved or rejected, and, 拒收，以及所有与这些批次相关的记录。 where applicable, records associated with the batch.
(2) A review of complaints, recalls, returned or (2)审核投诉、召回、退货或再利用的药品，和salvaged drug products, and investigations 按211?192下进行的调查。 conducted under 211.192 for each drug product.
(f) Procedures shall be established to assure (f)应建立确认企业负责人责任的程序，如果他that the responsible officials of the firm, if they 们没有亲自参与或无法及时知道以下情况，应are not personally involved in or immediately 以书面形式进行通知，包括按21 CFR aware of such actions, are notified in writing of 211?198、211?204或211?208部分实施的任何any investigations conducted under 211.198, 调查，FDA发出的召回和检查报告，或FDA规211.204, or 211.208 of these regulations, any 定的GMP相关法规。 recalls, reports of inspectional observations issued by the Food and Drug Administration, or any regulatory actions relating to good manufacturing practices brought by the Food and Drug Administration.
[43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995]
Sec. 211.182 Equipment cleaning and use log. 211.182设备清洁和使用日志
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21CFR Part 210&211
A written record of major equipment cleaning, maintenance (except routine maintenance such 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 (or, if the cleaning and maintenance is performed using automated equipment under 211.68, just the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order. [73 FR 51933, Sept. 8, 2008]
Sec. 211.184 Component, drug product 211.184组份、药品容器、密封器及标签记录 container, closure, and labeling records. These records shall include the following:
这些记录要包括下列信息：
(a)收到的每批组份、药品容器、密封器和标签的特征与数量；供应商名称；供应商的批号（如果知道的话）；按211?80指定的接收代码和接收日期。如果主要生产商和供应商不同，要列出生产商的名称和地址（如果知道的话）。
(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.
主要设备的清洁、维护（常规维护除外，如润滑、调整）和使用的书面记录，要包括在单独的设备日志中。此记录列有日期、时间、产品和每批的加工批号等内容。若设备只用于生产一种药品，使用流水号式的批号（单批或整批）且按号码顺序生产，那么，不要求单独的设备日志。如果使用的是专用设备，其清洁、维护和使用记录是批记录的一部分。执行清洁和维护的人员以及双复核的人员（如果清洁和维护过程由211.68提到的自动化设备执行，只需要一人确认该过程已完成）记录日期、签名表明该工作已完成，开始工作日志。记录中的每个条目，按时间的顺序排列。
(b) The results of any test or examination (b)任何检验结果（包括按211?82（a）211?84(d)performed (including those performed as 或211?122（a）的要求进行的检验结果）和从required by 211.82(a), 211.84(d), or 中得到的结论。 211.122(a)) and the conclusions derived there from.
(c) An individual inventory record of each (c)每个组份、药品容器、密封器的库存记录和component, drug product container, and 每种组份的物料使用核对记录。存货记录应含closure and, for each component, a 有足够的信息来对药品生产配料进行核实。 reconciliation of the use of each lot of such component. The inventory record shall contain
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