310.3(l) of this chapter and required under the 响本章310?3（L）规定的特殊包装的任何要Poison Prevention Packaging Act of 1970. 求和1970年毒药保护包装条例的要求（经管理和预算处批准，控制号091 0149）[54(Approved by the Office of Management and Budget under OMB control number 0910-0149) 联邦注册5228，1989年2月2日]。 [54 FR 5228, Feb. 2, 1989] § 211.134 Drug product inspection. (a) Packaged and labeled products shall be examined during finishing operations to provide assurance that containers and packages in the lot have the correct label. (b) A representative sample of units shall be collected at the completion of finishing operations and shall be visually examined for correct labeling. (c) Results of these examinations shall be recorded in the batch production or control records. § 211.137 Expiration dating. (a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § 211.166. (b) Expiration dates shall be related to any storage conditions stated on the labeling, as determined by stability studies described in §211.166. (c) If the drug product is to be reconstituted at the time of dispensing, its labeling shall bear expiration information for both the reconstituted and unreconstituted drug products. (d) Expiration dates shall appear on labeling in accordance with the requirements of § 201.17 211?134药品检查 (a)在结束工作时，应检查已包装和贴标签的产品，保证本批容器和包装的标签正确无误。 (b)操作结束时，每组收集一个代表性样品，同时检查标签。 (c)检查结果记录在该批的生产或控制记录中。 211?137有效期 (a)保证一个产品在使用时符合均一性、效价或含量、质量和纯度等标准，应提供一个有效期。有效期按211?166所述的稳定性试验测定。 (b)有效期是在符合标签上规定的贮存条件下，按211?166所述的稳定性试验测定。 (c)如药品在配制时要重新配伍，那重新配伍好的和未重新配伍的两种药品标签上均须提供有效日期。 (d)根据本章201?17的要求，有效日期应标of this chapter. (e) Homeopathic drug products shall be exempt from the requirements of this section. (f) Allergenic extracts that are labeled \Standard of Potency'' are exempt from the requirements of this section. (g) New drug products for investigational use are exempt from the requirements of this section, provided that they meet appropriate standards or specifications as demonstrated by stability studies during their use in clinical investigations. Where new drug products for investigational use are to be reconstituted at the time of dispensing, their labeling shall bear expiration information for the reconstituted drug product. (h) Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this section shall not be enforced for human OTC drug products if their labeling does not bear dosage limitations and they are stable for at least 3 years as supported by appropriate stability data. [43 FR 45077, Sept. 29, 1978, as amended at 46 FR 56412, Nov. 17, 1981; 60 FR 4091, Jan. 20, 1995] 在标签上。 (e)顺势治疗（homeopathic）药品免除本部分的要求。 (f)标“没有美国效价标准”的变应原提取物免除本部分要求。 (g)对于调查研究用新药，如果它们符合合适的标准或规格，并在临床研究使用能证明其稳定性，可以免除本部分要求。如研究用新药在配制时要重新配伍，那重新配伍好的药品标签上须标明有效日期。 (h) 1978年9月29日联邦注册发表了一个未决的免除提议，本章的要求可以对人用OTC药品不执行，只要它们的标签不包括剂量限制而且在3年内稳定并有适当的稳定性数据来支持。 [43联邦注册45077，1978年9月29日，修正，在46联邦56412，1981年11月17日，在60联邦4091，1995年1月20]。 H．贮存和销售 211?142入库程序 Subpart H-Holding and Distribution § 211.142 Warehousing procedures. Written procedures describing the warehousing 制订和遵循药品入库程序，包括： of drug products shall be established and followed. They shall include: (a)在质量控制部门放行前，药品待验。 (a) Quarantine of drug products before release by the quality control unit. (b)药品在适当的温度、湿度和照明下贮存， 不影响药品的均一性、效价或含量、质量及(b) Storage of drug products under appropriate conditions of temperature, humidity, and light 纯度。 so that the identity, strength, quality, and purity of the drug products are not affected. 211?150销售程序 § 211.150 Distribution procedures. Written procedures shall be established, and followed, describing the distribution of drug products. They shall include: (a) A procedure whereby the oldest approved stock of a drug product is distributed first. Deviation from this requirement is permitted if such deviation is temporary and appropriate. 制订和遵循药品销售程序，包括： (a)最早批准入库的药品，应先销售。若违背本要求的地方是暂时和适可的，这是允许的。 (b)通过每批药品的销售系统，能迅速追查(b) A system by which the distribution of each 药品，便于有必要召回。 lot of drug product can be readily determined to facilitate its recall if necessary. I?实验室控制 Subpart I-Laboratory Controls § 211.160 General requirements. (a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. The requirements in this subpart shall be followed and shall be documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms shall be recorded and justified. (b) Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and 211?160总要求 (a)按本部分的要求，制订规格、标准、取样方法、试验程序或其他实验室控制机制，包括上述内容的修改，由有关部门起草，并经质量控制部门审核、批准。遵守本部分中各要求，在实施时，提供证明文件。任何超出成文的规格、标准、取样方法、试验程序或其他实验室控制机制的偏差，应作记录，并提供证明。 (b)实验室控制内容，包括科学地制订完善、合理的规格、标准、取样方法及为保证各种成份、药品容器、密封件、中间体、标签和药品符合均一性、效价和含量、质量与纯度标准而设计的检验程序。实验室控制包括： drug products conform to appropriate standards of identity, strength, quality, and purity. Laboratory controls shall include: (1) Determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of components, drug product containers, closures, and labeling used in the manufacture, processing, packing, or holding of drug products. The specifications shall include a description of the sampling and testing procedures used. Samples shall be representative and adequately identified. Such procedures shall also require appropriate retesting of any component, drug product container, or closure that is subject to deterioration. (2) Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. Such samples shall be representative and properly identified. (3) Determination of conformance to written descriptions of sampling procedures and appropriate specifications for drug products. Such samples shall be representative and properly identified. (4) The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, 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. (1)根据接收的规格，测定用于药品生产、加工包装及贮存的每装货量中的每批的成份、药品容器、密封件和标签。保证它们符合制定的规格标准。此规格包括使用的取样和检验程序说明。样品有代表性及经适当鉴别。这些程序亦要求对任何变质的成份、药品容器或密封件作重复检验。 (2)根据中间体的成文规格和取样及检验程序，测定中间体。样品应有代表性和经适当鉴定。 (3)根据产品的成文规格和取样及检验程序，测定产品。样品应有代表性和经适当鉴定。 (4) 设备、仪器、量具和记录设备的校验有适当的间隔，符合已经建立的书面程序，该程序包括详细的指导、时间表、准确度和精密度的限度、当准确度/精密度不符合限度时的校正措施。设备、仪器、量具和记录设备不符合已经建立的质量标准时不得使用。 211?165销售前的检验与放行