发布时间 : 星期五 文章美国cGMP-中英文对照更新完毕开始阅读eba538c0de80d4d8d05a4fb2
21CFR Part 210&211
(4) The calibration of instruments, apparatus, (4)根据已建立的文件要求定期对仪器、设备、gauges, and recording devices at suitable 量具和记录装置的校验，这个文件要包括具体intervals in accordance with an established 指南、计划、准确度和精确度的限度以及不符written program containing specific directions, 合此限度时的补救措施。不符合已制定规格的schedules, limits for accuracy and precision, 仪器、设备、量具和记录装置则不能使用。 and provisions for remedial action in the event accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]
Sec. 211.165 Testing and release for 211.165销售的检验与放行 distribution.
(a) For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Where sterility and/or pyrogen testing are conducted on specific batches of short lived radiopharmaceuticals, such batches may be released prior to completion of sterility and/or pyrogen testing, provided such testing is completed as soon as possible.
(a) 每批药品放行前须经实验室检测，保证其符合药品的最终质量标准，包括均一性和每种活性成份的效价。对特定几批有效期短的放射性药物进行无菌和/或热原试验，如果这些检测可以尽快完成，那么这些批次可以在检测完成前放行。
(b) There shall be appropriate laboratory (b) 每批药品都必须有适当的实验室检验，来要testing, as necessary, of each batch of drug 求没有有害微生物，。 product required to be free of objectionable microorganisms.
(c) Any sampling and testing plans shall be (c)任何取样和检测计划，应在文件中说明。此described in written procedures that shall 程序要包括取样方法和每批检验的数量，并执include the method of sampling and the 行。 number of units per batch to be tested; such written procedure shall be followed. (d) Acceptance criteria for the sampling and testing conducted by the quality control unit shall be adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. The statistical quality control criteria shall include appropriate acceptance levels and/or appropriate rejection levels.
(d)由质量控制部门施行的取样和检验的可接收标准应足以保证药品符合各自的质量标准和统计学的质量控制标准，并作为药品批准和放行的条件。此统计学质量控制标准要包括合理的接收水平和/或拒收水平。
(e) The accuracy, sensitivity, specificity, and (e)厂商要确定所应用的检验方法的准确性、灵reproducibility of test methods employed by the 敏性、专属性和重现性，并起草文件。此类验firm shall be established and documented. 证和文字说明，要符合211?194（a）(2)。
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21CFR Part 210&211
Such validation and documentation may be accomplished in accordance with 211.194(a)(2). (f) Drug products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected. Reprocessing may be performed. Prior to acceptance and use, reprocessed material must meet appropriate standards, specifications, and any other relevant critieria. Sec. 211.166 Stability testing.
(f)不符合制订的标准或质量标准和其他有关质量控制标准的药品，应拒收，但可进行返工。在接收和应用前，被返工的药品要符合标准、质量标准和其他相关标准。
211.166稳定性试验
(a) There shall be a written testing program (a)药品稳定性考察要起草试验方案。此稳定性designed to assess the stability characteristics 试验的结果可用于确定合适的储存条件和有效of drug products. The results of such stability 期。起草的方案要被执行并且要包括： testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed and shall include:
(1) Sample size and test intervals based on (1) 样品量和检测周期，是基于各自的检查特征statistical criteria for each attribute examined to 的统计学标准而定，保障稳定性评价的有效性。 assure valid estimates of stability;
(2) Storage conditions for samples retained for (2)待检测样品的储存条件。 testing;
(3) Reliable, meaningful, and specific test (3)可靠的、有意义的具体的试验方法 methods;
(4) Testing of the drug product in the same (4) 待检药品的包装与市售包装一致。 container-closure system as that in which the drug product is marketed;
(5) Testing of drug products for reconstitution (5) 销售时（按标签指出的）和配伍后药品的检at the time of dispensing (as directed in the 测。 labeling) as well as after they are reconstituted.
(b) An adequate number of batches of each (b)要检验足够批次的药品，来确定一个适当的drug product shall be tested to determine an 有效期，这些数据资料的记录要保留。如果全appropriate expiration date and a record of 面的有效期实验没有进行或正在实行，可以用such data shall be maintained. Accelerated 加速实验，结合组份、药品及容器-封闭系统的studies, combined with basic stability 基本稳定性信息，确定有效期。如果加速实验information on the components, drug products, 推算的暂时有效期超过实际有效期研究支持的and container-closure system, may be used to 日期，必须进行稳定性考察，包括适当周期的support tentative expiration dates provided full 药品检测，直至暂时的有效期被证实或确定了shelf life studies are not available and are 合理的有效期。 being conducted. Where data from accelerated studies are used to project a tentative expiration date that is beyond a date supported by actual shelf life studies, there must be stability studies conducted, including drug product testing at appropriate intervals, until
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21CFR Part 210&211
the tentative expiration date is verified or the appropriate expiration date determined.
(c) For homeopathic drug products, the (c)本部分对同种疗法药品的要求如下： requirements of this section are as follows:
(1) There shall be a written assessment of (1)有一个基于检测药品组份间相容性的稳定性stability based at least on testing or 文字评估。同时，根据药品销售经验，指出正examination of the drug product for 常或预期的服用期间内，药品没有降解变质。 compatibility of the ingredients, and based on marketing experience with the drug product to indicate that there is no degradation of the product for the normal or expected period of use.
(2) Evaluation of stability shall be based on the (2)稳定性评价应基于与市售药品相同的包装。 same container-closure system in which the drug product is being marketed.
(d) Allergenic extracts that are labeled \ (d)标有“非美国效价标准”变应原提取物，免除U.S. Standard of Potency\本部分要求。 requirements of this section.
[43 FR 45077, Sept. 29, 1978, as amended at 46 FR 56412, Nov. 17, 1981]
Sec. 211.167 Special testing requirements.
211.167特殊检验要求
(a) For each batch of drug product purporting (a)对于无菌和/或无热原的每批药品，应进行合to be sterile and/or pyrogen-free, there shall be 适的实验室检测来考察与标准的一致性，这些appropriate laboratory testing to determine 检验程序应成文并遵循。 conformance to such requirements. The test procedures shall be in writing and shall be followed.
(b) For each batch of ophthalmic ointment, (b)对于每批眼膏，应检测异物微粒、粗糙或磨there shall be appropriate testing to determine 蚀物质与质量标准的一致性。检验程序应写成conformance to specifications regarding the 文字并执行。 presence of foreign particles and harsh or abrasive substances. The test procedures shall be in writing and shall be followed.
(c) For each batch of controlled-release (c)每批控释制剂都有合适的实验室检验，来测dosage form, there shall be appropriate 定每一活性成份药品的释放速率和标准的一致laboratory testing to determine conformance to 性，这个测试过程要写成文字并执行。 the specifications for the rate of release of each active ingredient. The test procedures shall be in writing and shall be followed. Sec. 211.170 Reserve samples.
211.170 留样
(a) An appropriately identified reserve sample (a) 收到的每批活性成份都要保存代表性留样that is representative of each lot in each 并进行适当标识。无菌和热原检测除外，留样shipment of each active ingredient shall be 最少为二倍全检所需量，以确定活性成分是否retained. The reserve sample consists of at 符合已建立的标准。保留时间要求如下： least twice the quantity necessary for all tests required to determine whether the active
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21CFR Part 210&211
ingredient meets its established specifications, except for sterility and pyrogen testing. The retention time is as follows:
(1) For an active ingredient in a drug product (1)除本段（a）（2）和（3）要求外的其他药品other than those described in paragraphs (a) 中活性成份，留样至保留至使用本批生产的最(2) and (3) of this section, the reserve sample 后一批产品的有效期后一年。 shall be retained for 1 year after the expiration date of the last lot of the drug product containing the active ingredient.
(2) For an active ingredient in a radioactive (2) 放射性药品中的活性成份（非放射活性试剂drug product, except for nonradioactive 盒除外）的留样应保留： reagent kits, the reserve 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last lot of the drug product containing the active 样保留至含此活性成份的最后一批药品的有效ingredient if the expiration dating period of the 期满后三个月。 drug product is 30 days or less;
(ii) Six months after the expiration date of the (ii)如果药品的有效期大于30天，留样保留至含last lot of the drug product containing the active 此活性成份的最后一批药品有效期满后六个ingredient if the expiration dating period of the 月。 drug product is more than 30 days.
(3) For an active ingredient in an OTC drug (3)根据211?137免除有效期的非处方药，其活product that is exempt from bearing an 性成份留样，保留至含此活性成份的最后一批expiration date under 211.137, the reserve 药品售出后三年。 sample shall be retained for 3 years after distribution of the last lot of the drug product containing the active ingredient.
(b) An appropriately identified reserve sample (b) 每批成品要有代表性留样并进行适当标识，that is representative of each lot or batch of 且按标签指定的条件储存。留样要储存在与市drug product shall be retained and stored 售内包装相同或与市售内包装本质上相同的包under conditions consistent with product 装内。留样最少为二倍全检所需量，无菌和热labeling. The reserve sample shall be stored in 原检测除外。除（b）（2）中述及的药品外，通the same immediate container-closure system 过可接受的统计学程序获取的代表性留样，除in which the drug product is marketed or in one 非目检会影响留样的完整性，每年至少目检一that has essentially the same characteristics. 次留样，来获取变质的迹象。任何留样变质的The reserve sample consists of at least twice 迹象，都应根据211?192进行调查。检查结果the quantity necessary to perform all the 应记录并和该药品的其他稳定性资料一起保required tests, except those for sterility and 留。医用压缩气体留样不保留。药品留样时间pyrogens. Except for those for drug products 如下： described in paragraph (b)(2) of this section, reserve samples from representative sample lots or batches selected by acceptable statistical procedures shall be examined visually at least once a year for evidence of deterioration unless visual examination would affect the integrity of the reserve sample. Any
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