§ 211.165 Testing and release for 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 shortlived radiopharmaceuticals, such batches may be released prior to completion of sterility and/or pyrogen testing, provided such testing is completed as soon as possible. (b) There shall be appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms. (c) Any sampling and testing plans shall be described in written procedures that shall include the method of sampling and the 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. (e) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with § 211.194(a)(2). (f) Drug products failing to meet established (a)每批药品发放前须经实验室检测，保证其符合药品的最终规格标准，包括均一性和活性成份的含量。对有效期短的，需无菌和/或热原试验的放射药物特殊批号，可在无菌和/或热原试验完成前放行，但应规定尽快完成试验。 (b)根据需要，每批药品应进行适当的实验室有害微生物检验。 (c)任何取样和检验方法，应在成文程序中说明。此程序包括取样方法和每批检验的取样数量，并遵循。 (d)对质量控制部门的取样和检验的接收标准是满足保证那些药品符合各自的规格标准和统计学的质量控制标准。这些标准是批准和发放药品的条件。此统计学质量控制标准包括适当的接收水平和/或适当的拒收水平。 (e)证实和提供文件证明经严格使用的检验方法的准确性、灵敏性、专属性和重现性。此验证和文件，可按照211?194（a）(2)项完成。 (f)不符合制订的标准、规格和其他有关质量控制标准的药品，应拒收，但可返工。被 返工的药品，在接收和应用前，须符合标准、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 criteria. § 211.166 Stability testing. 规格和其他有关标准 211?166稳定性试验 (a)有一个设计确定药品稳定性的成文试验方案。此试验用于测定合适的贮存条件和有效期。该方案应包括： (a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The (1)样品量和检测周期。是基于各自的检查written program shall be followed and shall include: 特征的统计学标准而定，保障稳定性评价的 (1) Sample size and test intervals based on statistical criteria for each attribute examined to (2)保留样品的贮存条件。 assure valid estimates of stability; (2) Storage conditions for samples retained for (3)可靠的、有意义和有效的试验方法。 testing; (3) Reliable, meaningful, and specific test methods; (4) Testing of the drug product in the same container-closure system as that in which the drug product is marketed; (4)使用与上市销售药品相同的容器密闭系统。 (5)配制时，配伍的药品（按标签指出的）和配制后的药品的检验。 (5) Testing of drug products for reconstitution at the time of dispensing (as directed in the (b)每个药品有足够批号受检，测定一个适labeling) as well as after they are reconstituted. 当的有效期，并保留这些资料。结合成份、 (b) An adequate number of batches of each drug product shall be tested to determine an appropriate expiration date and a record of such data shall be maintained. Accelerated studies, combined with basic stability information on the components, drug products, and container-closure system, may be used to support tentative expiration dates provided full shelf life studies are not available and are being conducted. Where data from accelerated 药品及容器-封闭系统的基本稳定性资料的“加速实验”，用于支持提供足够的货架寿命的实验性有效期是不合适的，而且，这种研究正在实行。使用“加速实验”提供的资料，设计实验性有效期，此有效期是后于由实际货架研究支持的日期。必须实施产品稳定性试验，包括适当检验周期，直至此实验性有效期被证实或被确定为止。 正确性。 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 the tentative expiration date is verified or the appropriate expiration date determined. (c) For homeopathic drug products, the requirements of this section are as follows: (1) There shall be a written assessment of stability based at least on testing or examination of the drug product for 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. (c)本部分对顺势治疗药品的要求如下： (1)对各成份间的可配伍性，有一个基于药品的检验或测定的稳定性文字评价。同时，根据药品销售经验，证明正常的或预期的使用期内，药品没有降解变质。 (2)稳定性评价应建立在与上市销售相同的容器封闭系统基础上。 (2) Evaluation of stability shall be based on the same container-closure system in which the drug product is being marketed. (d)标有“没有美国效价标准”变应原提取物，免除本部分要求 (d) Allergenic extracts that are labeled \U.S. Standard of Potency'' are exempt from the [43联邦注册4507，1978年9月29日，修正，在requirements of this section. 46联邦56412，1981年11月17日] [43 FR 45077, Sept. 29, 1978, as amended at 46 FR 56412, Nov. 17, 1981] 211?167特殊检验要求 § 211.167 Special testing requirements. (a) For each batch of drug product purporting to be sterile and/or pyrogen-free, there shall be appropriate laboratory testing to determine conformance to such requirements. The test procedures shall be in writing and shall be followed. (b) For each batch of ophthalmic ointment, there shall be appropriate testing to determine conformance to specifications regarding the presence of foreign particles and harsh or abrasive substances. The test procedures shall (a)对于标明无菌和/或无热原的每批药品，应有检查符合此要求的实验室检验。检验程序应成文并遵循。 (b)对于每批眼膏，应有测定符合有关外部微粒，粗糙或磨蚀物质存在的检验。检验程序应成文并遵循。 be in writing and shall be followed. (c) For each batch of controlled-release dosage form, there shall be appropriate laboratory testing to determine conformance to the specifications for the rate of release of each active ingredient. The test procedures shall be in writing and shall be followed. § 211.170 Reserve samples. (a) An appropriately identified reserve sample that is representative of each lot in each shipment of each active ingredient shall be retained. The reserve sample consists of at least twice the quantity necessary for all tests required to determine whether the active 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 other than those described in paragraphs (a) (2) and (3) of this section, the reserve sample shall be retained for 1 year after the expiration date of the last lot of the drug product containing the active ingredient. (c)每批控释制剂都有一实验室检验，测定每一活性成份释放比率。该检验程序应成文并遵循。 211?170留样 (a)每次到货的每批活性成份经鉴别后，留样。留样最少二倍于满足全部测定所需样品数量，无菌和热原检验所需量除外。保留时间要求如下： (1)药品中的活性成份，除按符合本段（a）（2）和（3）要求外，留样至含该批活性成份的最后一批产品的有效期后一年。 (2)放射性药品中的活性成份（非放射活性试剂盒除外）的留样保留： (2) For an active ingredient in a radioactive drug product, except for nonradioactive reagent (I)如果药品有效期是三十天或以内，留样kits, the reserve sample shall be retained for: 保留期是含此活性成份的最后一批药品的 (I) Three months after the expiration date of the last lot of the drug product containing the active ingredient if the expiration dating period of the drug product is 30 days or less; or 有效期满后三个月。 (ii) 如果药品有效期是三十天以上，留样保留期是含此活性成份的最后一批药品的(ii) Six months after the expiration date of the 有效期满后六个月。 last lot of the drug product containing the active ingredient if the expiration dating period of the (3)根据211?137免除有效期的非处方药，drug product is more than 30 days. 其活性成分留样，是含此活性成份药品的最 (3) For an active ingredient in an OTC drug product that is exempt from bearing an expiration date under § 211.137, the reserve 后一批药品销售后三年。