drug product container, or closure. § 211.89 Rejected components, drug product containers, and closures. Rejected components, drug product containers, and closures shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable. § 211.94 Drug product containers and closures. (a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements. (b) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product. (c) Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. (d) Standards or specifications, methods of testing, and, where indicated, methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures. 211?89拒收的成份、药品容器和密封件 拒收的成份、药品容器和密封件应经鉴定和在隔离系统下加以控制，防止在生产加工使用。 211?94药品密封容器和密封件 (a)药品包装容器和密封件应不起反应、不吸着、不吸附、不致改变药品的安全性、均一性、含量或效价、质量和纯度而超出制定的或其它颁布的规定要求。 (b)容器封口系统应对贮藏和使用过程中可预见的能引起药品变质或污染的外部因素提供足够的防护。 (c)药品容器和密封件应清洁、灭菌和除热原，保证其适用于预期目的。 (d)药品容器和密封件的标准或规格、检验方法（指清洁和消毒方法、除热原过程）应成文并遵循。 Subpart F-Production and Process Controls F. 生产和加工控制 § 211.100 Written procedures; deviations. (a) There shall be written procedures for production and process control designed to 211?100成文的规程、偏差 (a)编写为保证药品的均一性、含量或效价、assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified. § 211.101 Charge-in of components. 质量及纯度而设计的生产和加工控制程序，这些程序包括本部内全部要求。这些成文程序（包括变化）须经有关部门起草、审核和批准，然后再经质量控制部门审核与批准。 (b)在实施各种生产和加工控制功能中，遵循已制定的生产和加工控制程序，并在实施时以文件记录加以证明。程序中出现的任何偏差，应作记录，并提出证据。 211?101成分的控制 Written production and control procedures shall 成文的生产和控制程序包括下面的内容，其include the following, which are designed to assure that the drug products produced have 设计应保证所生产的药品具有的均一性、含the identity, strength, quality, and purity they 量和效价、质量和纯度。 purport or are represented to possess: (a) The batch shall be formulated with the intent (a)按处方配制的药品，保证其活性成份含to provide not less than 100 percent of the 量不低于100%标示量或规定量。 labeled or established amount of active ingredient. (b) Components for drug product manufacturing shall be weighed, measured, or subdivided as appropriate. If a component is removed from the original container to another, the new container shall be identified with the following information: (1) Component name or item code; (2) Receiving or control number; (3) Weight or measure in new container; (b)生产药品用的成份应称量、测量或适当粉碎。若一种成份从原来容器转移到另一容器内，新容器上应有下列标识内容： (1)成份名称或项目代码。 (2)接收或控制号。 (3)在新容器中的重量或份量。 (4) Batch for which component was dispensed, including its product name, strength, and lot (4)使用此成份配制的一批药品，包含其产number. (c) Weighing, measuring, or subdividing operations for components shall be adequately supervised. Each container of component dispensed to manufacturing shall be examined by a second person to assure that: 品名称、规格和批号。 (c)成份的称重、测量或粉碎操作，应受到严密的监督。盛放用于生产成份的每一容器，须经第二人检查，保证： (1) The component was released by the quality (1)此成份是由质量控制人员放行的。 control unit; (2) The weight or measure is correct as stated in the batch production records; (3) The containers are properly identified. (d) Each component shall be added to the batch by one person and verified by a second person. § 211.103 Calculation of yield. Actual yields and percentages of theoretical yield shall be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product. Such calculations shall be performed by one person and independently verified by a second person. § 211.105 Equipment identification (a) All compounding and storage containers, processing lines, and major equipment used during the production of a batch of a drug product shall be properly identified at all times to indicate their contents and, when necessary, the phase of processing of the batch. (b) Major equipment shall be identified by a distinctive identification number or code that shall be recorded in the batch production record to show the specific equipment used in the manufacture of each batch of a drug product. In cases where only one of a particular (2)重量或份量正确，与批生产记录一致。 (3)容器经严格区别。 （d）每一成份投料时，一人操作，另一人核对。 211?103 产量计算 在药品生产、加工或贮存的每一适当阶段结束时，测算实际产量与理论产量的百分比。这个计算应由一人执行后，由另外一人独立进行核实。 211?105设备鉴别 (a)在整个生产周期内，同批药品生产使用的全部混合和贮存容器、生产线和主要设备应严格识别，标示出药品的成份，必要时，还应标出所处的加工阶段。 (b)一种药品每批生产使用的主要设备，以一鉴别性识别号或代号加以识别。此鉴别号或代号记录在该批号产品的记录本。若生产中只使用一种特殊型号的设备，可用该设备名字代替鉴别性识别或代号。 type of equipment exists in a manufacturing facility, the name of the equipment may be used in lieu of a distinctive identification number or code. § 211.110 Sampling and testing of in-process materials and drug products. (a) To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Such control procedures shall include, but are not limited to, the following, where appropriate: (1) Tablet or capsule weight variation; (2) Disintegration time; (3) Adequacy of mixing to assure uniformity and homogeneity; (4) Dissolution time and rate; (5) Clarity, completeness, or pH of solutions. (b) Valid in-process specifications for such characteristics shall be consistent with drug product final specifications and shall be derived from previous acceptable process average and process variability estimates where possible and determined by the application of suitable statistical procedures where appropriate. Examination and testing of samples shall assure that the drug product and in-process materials conform to specifications. 211?110中间体和药品的取样与检验 (a)制订和遵循说明每批的加工过程控制及对加工过程中材料的适当样品实行检验或检查的成文程序，保证药品的一致性和完整性。这些控制程序应当建立并用于监控产出和验证生产工艺的性能，考虑可能的引起产品和过程物料的性质变化的原因。上述控制程序包括，但不限于如下内容： (1)片剂或胶囊的重量差异。 (2)崩解时间。 (3)充分混和，保证均匀。 (4)溶解时间和速率。 (5)溶液的澄明度、溶解完全性及PH值。 (b)考虑上述特性而制定的有效中间加工规格与药品最终规格一致。此中间加工规格应在以前可靠的加工方法稳定性评估和经应用统计学程序断定认为合适的基础上制定的。样品测试，保证药品和中间体符合规格标准。