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21CFR Part 210&211
sufficient information to allow determination of any batch or lot of drug product associated with the use of each component, drug product container, and closure.
(d) Documentation of the examination and (d)根据211?122（c）和211?130（c）的要求，review of labels and labeling for conformity 检查或审核标签和贴标签与已建立的质量标准with established specifications in accord with 的一致性，并形成文件。 211.122(c) and 211.130(c).
(e) The disposition of rejected components, (e)拒收组份、药品容器、密封器和标签的处理 drug product containers, closure, and labeling.
Sec. 211.186 Master production and control 211.186主生产和控制的记录 records.
(a) To assure uniformity from batch to batch, master production and control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed (full signature, handwritten) by one person and independently checked, dated, and signed by a second person. The preparation of master production and control records shall be described in a written procedure and such written procedure shall be followed.
(a)为确保批与批之间的一致性，每个品种的主生产和控制记录（包括批量），由一人填写并签名签日期（全名、手写）。由另一个人独立复核，并签名签日期。主生产和控制记录的填写，要有程序规定并执行。
(b) Master production and control records shall (b)主生产和控制记录包括： include:
(1) The name and strength of the product and (1)产品名称、规格和剂型的描述 a description of the dosage form;
(2) The name and weight or measure of each (2)单位剂量或单位重量或单位体积的药品中各active ingredient per dosage unit or per unit of 活性成份的名称和重量或体积。以及任何剂量weight or measure of the drug product, and a 单位的总重或总体积的说明。 statement of the total weight or measure of any dosage unit;
(3) A complete list of components designated (3)一个完整的，以名字或代码表示的组份列表，by names or codes sufficiently specific to 充分显示具体的质量特性； 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 variations may be permitted, however, in the amount of components necessary for the preparation in the dosage form, provided they are justified in the master production and control records;
(4)准确表明各组份的重量或容量，各组份使用同一计量系统（公制、常衡或药衡制）。生产过程中组份量的改变，如果它们在该主生产和控制记录中被证实，这种合理的变动是允许的；
(5) A statement concerning any calculated (5)有关任何组份的计算超量的说明 excess of component;
(6) A statement of theoretical weight or (6)在适当加工阶段，理论重量或体积的说明
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measure at appropriate phases of processing;
(7) A statement of theoretical yield, including (7)理论产量的声明，包括根据211?192要求，the maximum and minimum percentages of 对超过理论产量最大和最小百分率的调查说明 theoretical yield beyond which investigation according to 211.192 is required;
(8) A description of the drug product (8)药品容器、密封器和包装材料的描述，包括containers, closures, and packaging materials, 标签和全部其它标签的样本或复制件的说明。including a specimen or copy of each label and 这些样本或复制件要经对此负责的人员批准，all other labeling signed and dated by the 签名和注明日期。 person or persons responsible for approval of such labeling;
(9) Complete manufacturing and control (9) 需遵照执行完整的生产和控制指令，取样和instructions, sampling and testing procedures, 检验程序、各种质量标准，各种特殊的注解和specifications, special notations, and 各种注意事项。 precautions to be followed.
Sec. 211.188 Batch production and control 211.188批生产和控制记录 records.
Batch production and control records shall be 每批生产的药品要有批生产和控制记录，包括prepared for each batch of drug product 每批有关生产和控制的完整资料。这些记录包produced and shall include complete 括： information relating to the production and control of each batch. These records shall include:
(a) An accurate reproduction of the appropriate (a)适当的主生产或控制记录正确无误的复制master production or control record, checked 件，复核其准确性、注明日期并签名； for accuracy, dated, and signed;
(b) Documentation that each significant step in (b)完成本批生产、加工、包装或储存中各项重the manufacture, processing, packing, or 要步骤中须提供的文件，包括： holding of the batch was accomplished, including: (1) Dates;
(1)日期
(2) Identity of individual major equipment and (2)使用的重要设备和生产线的说明； lines used;
(3) Specific identification of each batch of (3)每批使用的组份或中间体的具体特性； component or in-process material used;
(4) Weights and measures of components (4)加工过程中使用的组份的重量和容量； used in the course of processing;
(5) In-process and laboratory control results; (5)中控和实验室控制结果
(6) Inspection of the packaging and labeling (6)使用前后，包装和贴标签区域的检查 area before and after use;
(7) A statement of the actual yield and a (7)在适当的加工阶段，实际产量和理论产量百statement of the percentage of theoretical yield 分比说明 at appropriate phases of processing;
(8) Complete labeling control records, (8)完整的标签控制记录，包括使用的全部标签including specimens or copies of all labeling 样本或复制件 used;
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(9) Description of drug product containers and (9)药品容器和密封器的说明 closures;
(10) Any sampling performed;
(10)已完成的取样
(11) Identification of the persons performing (11)每一关键生产步骤中的操作人员、直接监督and directly supervising or checking each 人员或复核人员的确认；或是在211.68下由自significant step in the operation, or if a 动仪器完成的关键步骤中的复核人员的确认。 significant step in the operation is performed by automated equipment under 211.68, the identification of the person checking the significant step performed by the automated equipment.
(12) Any investigation made according to (12) 按211?192进行的任何调查。 211.192.
(13) Results of examinations made in (13) 按211?134处理的检查结果。 accordance with 211.134. [43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51933, Sept. 8, 2008]
Sec. 211.192 Production record review.
211.192产品记录审核
所有药品生产和控制记录，包括包装和标签记录，须在药品放行或分发前，经过质量控制部门审核和批准，来确认与已建立的、批准的程序的一致性。任何无法解释的偏差（包括超过在主生产和控制记录中制订的理论产量的最大或最小限度的百分数）或一批成品或任何一个组份不符合其标准，则应作彻底调查，不管这批药品是否已分发。这种调查应延伸到该同种药品的其他批号以及与该不合格项或偏差有关联的其它药品。调查应写成文字记录，包括结论和后续跟踪。
All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow up. Sec. 211.194 Laboratory records.
211.194实验室记录
(a) Laboratory records shall include complete (a)实验记录包括所有所需检测的完整数据，来data derived from all tests necessary to assure 保证符合已制订的质量标准（包括检查项和含compliance with established specifications and 量）资料，包括： standards, including examinations and assays, as follows:
(1) A description of the sample received for (1)接收的检验用样品的相关信息：来源（取样
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testing with identification of source (that is, location from where sample was obtained), quantity, lot number or other distinctive code, date sample was taken, and date sample was received for testing.
(2) A statement of each method used in the testing of the sample. The statement shall indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested. (If the method employed is in the current revision of the United States Pharmacopeia, National Formulary, AOAC INTERNATIONAL, Book of Methods,1or in other recognized standard references, or is detailed in an approved new drug application and the referenced method is not modified, a statement indicating the method and reference will suffice). The suitability of all testing methods used shall be verified under actual conditions of use.
地点）、数量、批号或其他的特性代码，取样日期及接收日期。
(2)样品检验方法的说明。此说明应指出样品检验方法依据的出处，检验方法应满足样品检测的准确度和可信度要求。（若使用的方法是在最新修订版美国药典、国家处方集、官方的分析化学协会（ABABC）、分析方法类书籍或在其它公认的标准文献或在已批准的新药申请中详述，参考方法没有修改，则一份声明表明该方法和参考资料就足够了）在实际使用情况下的检验方法的适用性应作确认。
(3) A statement of the weight or measure of (3)各个检验用样品的重量或容量的说明 sample used for each test, where appropriate. (4) A complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, drug product container, closure, in-process material, or drug product, and lot tested.
(4)每项检测的全部数据，包括：实验仪器测定的全部图谱、图表和光谱图，都应有一份完整的记录，并对其进行标识以表明所检测的组份、药品容器、密封器、中间体或成品和批号。
(5) A record of all calculations performed in (5)与检验有关的全部计算记录，包括测量单位、connection with the test, including units of 换算系数和当量系数。 measure, conversion factors, and equivalency factors.
(6) A statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the component, drug product container, closure, in-process material, or drug product tested.
(6)说明检验结果，组份、药品容器、密封器、中间体或成品的检测结果在均一性、规格、质量和纯度标准方面，同已制订标准的相比较如何。
(7) The initials or signature of the person who (7)每个检验人员签名及完成日期 performs each test and the date(s) the tests were performed.
(8) The initials or signature of a second person (8) 依照制订的标准，由另一员工复核原始记录showing that the original records have been 的准确性、完整性和一致性并签名。 reviewed for accuracy, completeness, and compliance with established standards.
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