21CFR Part 210&211
(b) Complete records shall be maintained of any modification of an established method employed in testing. Such records shall include the reason for the modification and data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method.
(b)检测中任何对已制定检验方法的修改都应保留完整的记录。此记录应包括修改的原因和数据并证明检验结果同修改前方法的结果至少同样准确、可靠。
(c) Complete records shall be maintained of (c)保留实验室标准品、试剂和标准溶液检测和any testing and standardization of laboratory 标定的完整记录。 reference standards, reagents, and standard solutions.
(d) Complete records shall be maintained of (d)按211?160（b）(4)的要求，定期校验实验室the periodic calibration of laboratory 仪器、装置、仪表和记录设备，并保留完整记instruments, apparatus, gauges, and recording 录。 devices required by 211.160(b)(4).
(e) Complete records shall be maintained of all (e)保留按21?166要求实施的全部稳定性试验stability testing performed in accordance with 的完整记录。 211.166.
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Copies may be obtained from: AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877.
[43 FR 45077, Sept. 29, 1978, as amended at 55 FR 11577, Mar. 29, 1990; 65 FR 18889, Apr. 10, 2000; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005]
Sec. 211.196 Distribution records.
211.196分发记录
Distribution records shall contain the name and 分发记录包括药品名称、规格，及该剂型的描strength of the product and description of the 述、收货人的姓名和地址、装运日期和数量、dosage form, name and address of the 药品批号或控制号。医用压缩气体产品的分发consignee, date and quantity shipped, and lot 记录不要求包括批号或控制号。 or control number of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers.
[49 FR 9865, Mar. 16, 1984] Sec. 211.198 Complaint files.
211.198投诉档案
(a) Written procedures describing the handling (a)制订并执行处理与药品有关的全部文字和口of all written and oral complaints regarding a 头投诉的程序。此程序包括经质量控制部门审drug product shall be established and followed. 核的条款，任一投诉中，药品有任一项不符合Such procedures shall include provisions for 其标准的可能，则根据211?192，对该药品进行review by the quality control unit, of any 调查和确定。这些程序应包括审核条款，来确complaint involving the possible failure of a 定投诉是否代表了严重的和意外的不良反应，drug product to meet any of its specifications 这些不良反应根据21CFR 310?305和514.80
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21CFR Part 210&211
and, for such drug products, a determination 部分，须向FDA报告。 as to the need for an investigation in accordance with 211.192. Such procedures shall include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration in accordance with 310.305 and 514.80 of this chapter. (b) A written record of each complaint shall be maintained in a file designated for drug product complaints. The file regarding such drug product complaints shall be maintained at the establishment where the drug product involved was manufactured, processed, or packed, or such file may be maintained at another facility if the written records in such files are readily available for inspection at that other facility. Written records involving a drug product shall be maintained until at least 1 year after the expiration date of the drug product, or 1 year after the date that the complaint was received, whichever is longer. In the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under 211.137, such written records shall be maintained for 3 years after distribution of the drug product.
(b)每个投诉的文字记录需存档。与该药品投诉有关的档案，应保存在其生产、加工或包装该药品的场地。若存放于别的场地会更有利于检查，可在那里保存。涉及药品的文字记录，记录保存产品有效期后一年或从收到投诉日期起一年，由时间较长者决定。在某些非处方药缺少有效期的情况下，由于它们符合211?137中免除条例，故这些文字记录的保存时间应是该药品全部分发后三年。
(1) The written record shall include the (1)在已知的情况下，投诉文字记录包括如下信following information, where known: the name 息：药品名称、规格、批号、投诉者姓名、投and strength of the drug product, lot number, 诉性质及投诉答复等。 name of complainant, nature of complaint, and reply to complainant. (2) Where an investigation under 211.192 is conducted, the written record shall include the findings of the investigation and follow up. The record or copy of the record of the investigation shall be maintained at the establishment where the investigation occurred in accordance with 211.180(c).
(2)执行211?192中的调查，要有包括此调查和跟踪中发现的内容的文字记录。调查报告记录或其复印件，根据211?180（c），保存在该调查建立的档案中。
(3) Where an investigation under 211.192 is (3)若没有执行211?192中的调查，此文字报告not conducted, the written record shall include 应包括没必要调查的原因和做此决定的负责人the reason that an investigation was found not 姓名。 to be necessary and the name of the
responsible person making such a
determination.[43 FR 45077, Sept. 29, 1978,
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21CFR Part 210&211
as amended at 51 FR 24479, July 3, 1986; 68 FR 15364, Mar. 31, 2003]
Subpart K--Returned and Salvaged Drug K--退回的药品和回收处理 Products
Sec. 211.204 Returned drug products.
211.204退回的药品
退回的药品按原药品作鉴定和保存。如果退回药品在退回前或退回期间的储存、运输条件或因药品、容器、纸板盒或标签由于储存或运输条件对药品的安全性、鉴别、规格、质量或纯度产生质疑，退回的药品要全部销毁，除非经检验、检查或调查，证明此药品符合其安全性、鉴别、规格、质量或纯度的标准。如果返工后药品符合适用的标准、质量标准标准和特性，那么药品是可以返工的。退回药品的记录应保存，记录包括退回药品的名称、标明的制剂功效、批号（控制号或整批批号）、退货原因及数量、销售日期及最终销售日期。若退货原因牵涉到多批产品，应依照211?192的要求进行一个合理的调查。储存，检验和返工的过程要有文字程序并遵循执行。
Returned drug products shall be identified as such and held. If the conditions under which returned drug products have been held, stored, or shipped before or during their return, or if the condition of the drug product, its container, carton, or labeling, as a result of storage or shipping, casts doubt on the safety, identity, strength, quality or purity of the drug product, the returned drug product shall be destroyed unless examination, testing, or other investigations prove the drug product meets appropriate standards of safety, identity, strength, quality, or purity. A drug product may be reprocessed provided the subsequent drug product meets appropriate standards, specifications, and characteristics. Records of returned drug products shall be maintained and shall include the name and label potency of the drug product dosage form, lot number (or control number or batch number), reason for the return, quantity returned, date of disposition, and ultimate disposition of the returned drug product. If the reason for a drug product being returned implicates associated batches, an appropriate investigation shall be conducted in accordance with the requirements of 211.192. Procedures for the holding, testing, and reprocessing of returned drug products shall be in writing and shall be followed. Sec. 211.208 Drug product salvaging.
211.208药品的再利用
Dug products that have been subjected to 药品因为不当的储存条件，包括极端的温度、improper storage conditions including 湿度、烟、雾、压力、时间或放射性，或是由extremes in temperature, humidity, smoke, 于自然灾害、火灾、事故或是仪器的不当就不fumes, pressure, age, or radiation due to 能挽回和返回市场。无论何时药品发生了上述natural disasters, fires, accidents, or 问题，只有在下列条件下，再利用操作可以进equipment failures shall not be salvaged and 行，（a）实验室测试和分析（包括实验用的动returned to the marketplace. Whenever there is 物研究），证明药品符合鉴别、规格、质量和a question whether drug products have been 纯度的标准以及（b）药品及他们包装没有在发subjected to such conditions, salvaging 生了灾难或事故的情况下，置于不适合的储存operations may be conducted only if there is 条件。外观上的检查只能作为药品满足鉴别、
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21CFR Part 210&211
(a) evidence from laboratory tests and assays (including animal feeding studies where applicable) that the drug products meet all applicable standards of identity, strength, quality, and purity and (b) evidence from inspection of the premises that the drug products and their associated packaging were not subjected to improper storage conditions as a result of the disaster or accident. Organoleptic examinations shall be acceptable only as supplemental evidence that the drug products meet appropriate standards of identity, strength, quality, and purity. Records including name, lot number, and disposition shall be maintained for drug products subject to this section。
规格、质量和纯度标准情况下可接受收的补充性证据。关于名称、批号和销售的记录要根据本节要求保存。
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