美国药品生产质量管理规范(DOC 54页).doc

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袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃芇羂袄膃薃袈袃芅莆螄袂莇薁蚀袁肇莄薆袀腿薀袅罿芁莂螁羈莄薈蚇羈膃莁蚃羇芆蚆蕿羆莈葿袈羅肈蚄螄羄膀蒇蚀肃节蚃薆肃莅蒆袄肂肄芈螀肁芇蒄螆肀荿莇蚂聿聿薂薈肈膁莅袇肇芃薀螃膇莅莃虿膆肅蕿薅膅膇莁羃膄莀薇衿膃蒂蒀螅膂膂蚅蚁蝿芄蒈薇螈莆蚄袆螇肆蒆螂袆膈蚂蚈袅芁蒅薄袄蒃蒄聿肀艿虿羅聿莁蒂袁肈薄蚈袇肇芃薀螃肇莆螆肁肆蒈蕿羇肅薀螄袃肄芀薇蝿膃莂螃蚅膂蒄薅羄膁膄螁羀膁莆蚄袆膀葿衿螂腿薁蚂肁膈芁蒅羇膇莃蚀袃芆蒅蒃蝿芅膅蚈蚅芅芇蒁肃芄蒀螇罿芃薂薀袅节节螅螁芁莄薈肀莀蒆螃羆莀薈薆袂荿芈螂螈羅蒀薄螄羄薃袀肂羃节蚃羈羃莅袈袄羂蒇蚁螀羁蕿蒄聿肀艿虿羅聿莁蒂袁肈薄蚈袇肇芃薀螃肇莆螆肁肆蒈蕿羇肅薀螄袃肄芀薇蝿膃莂螃蚅膂蒄薅羄膁膄螁羀膁莆蚄袆膀葿衿螂腿薁蚂肁膈芁蒅羇膇莃蚀袃芆蒅蒃蝿芅膅蚈蚅芅芇蒁肃芄蒀螇罿芃薂薀袅节节螅螁芁莄薈肀莀蒆螃羆莀薈薆袂荿芈螂螈羅蒀薄螄羄薃袀肂羃节蚃羈羃莅袈袄羂蒇蚁螀羁蕿蒄聿肀艿虿羅聿莁蒂袁肈薄蚈袇肇芃薀螃肇莆螆肁肆蒈蕿羇肅薀螄袃肄芀薇蝿膃莂螃蚅膂蒄薅羄膁膄螁羀膁莆蚄袆膀葿衿螂腿薁蚂肁膈芁蒅羇膇莃蚀袃芆蒅蒃蝿芅膅蚈蚅芅芇蒁肃芄蒀螇罿芃薂薀袅节节螅螁芁莄薈肀莀蒆螃羆莀薈薆袂荿芈螂螈羅蒀薄螄羄薃袀肂羃节蚃羈羃莅袈袄羂蒇蚁螀羁蕿蒄聿肀艿虿羅聿莁蒂袁肈薄蚈袇肇芃薀螃肇莆螆肁肆蒈蕿羇肅薀螄袃肄芀薇蝿膃莂螃蚅膂蒄薅羄膁膄螁羀膁莆蚄袆膀葿衿螂腿薁蚂肁膈芁蒅羇膇莃蚀袃芆蒅蒃蝿芅膅蚈蚅芅芇蒁肃芄蒀螇罿芃薂薀袅节节螅螁芁莄薈肀莀蒆螃羆莀薈薆袂荿芈螂螈羅蒀薄螄羄薃袀肂羃节蚃羈羃莅袈袄羂蒇蚁螀羁蕿蒄聿肀艿虿羅聿莁蒂袁肈薄蚈袇肇芃薀螃肇莆螆肁肆蒈蕿羇肅薀螄袃肄芀薇蝿膃莂螃蚅膂蒄薅羄膁膄螁羀膁莆蚄袆膀葿衿螂腿薁蚂肁膈芁蒅羇膇莃蚀袃芆蒅蒃蝿芅 GOOD MANUFACTURE PRACTICE美国药品生产质量管理规范（CGMP）二三年十二月 目 录210.1cGMP法规的地位2210.2cGMP法规的适用性2210.3定义2211-A-总则4211-B-组织与人员4211-C-厂房和设施5211-D-设备7211-E-成份、药品容器和密封件的控制8211-F-生产和加工控制10211-G-包装和标签控制11211-H-贮存和销售13211-I-实验室控制14211-J-记录和报告16211-K-退回的药品和回收处理20210部分人用及兽用药品的生产、加工、包装或贮存的CGMPPart 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 210.1 cGMP法规的地位 210.1 Status of current good manufacturing practice regulations. (a) 在本部分及21CFR 211226部分中陈述的法规是在药品生产、加工、包装或贮存中使用的现行生产质量管理规范及使用的设施或控制的最低标准，以保证该药品符合联邦食品、药品及化妆品法对安全性的要求，具有均一性和效价(或含量)并符合或代表其生产过程的质量及纯度等特征。 (a) The regulations set forth in this part and in Parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.(b) 凡是在药品生产、加工、包装或贮存过程中存在任何不符合本部分及21CFR 211226部分中陈述的法规的药品，依据联邦食品、药品及化妆品法501 (a)(2)-(B)，该药应被视为劣药，同时导致该事故发生的负责人应受相应的法规的制裁。(b) The failure to comply with any regulation set forth in this part and in Parts 211 through 226 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action. 210.2 cGMP法规的适用性 210.2 Applicability of current good manufacturing practice regulations.(a) 本部分及21CFR 211226适用于普通药品，21CFR 600680适用于人用生物制品，除非另有明确规定，否则上述两者之间应该是相互补充而不是相互取代。如有上述两部分的法规不适用的药品，则可用特定的具体法规来替代。(a) The regulations in this part and in Parts 211 through 226 of this chapter as they may pertain to a drug and in Parts 600 through 680 of this chapter as they may pertain to a biological product for human use, shall be considered to supplement, not supersede, each other, unless the regulations explicitly provide otherwise. In the event that it is impossible to comply with all applicable regulations in these parts, the regulations specifically applicable to the drug in question shall supersede the more general.(b) If a person engages in only some operations subject to the regulations in this part and in Parts 211 through 226 and Parts 600 through 680 of this chapter, and not in others, that person need only comply with those regulations applicable to the operations in which he or she is engaged. 210.3 定义 210.3 Definitions.(a) 在联邦食品、药品及化妆品法201部分中包含的定义和解释、说明适用于21CFR 211226部分中的术语。(a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in Parts 211 through 226 of this chapter.(b) 下面定义的术语适用于本部分及21CFR 211226。(b) The following definitions of terms apply to this part and to Parts 211 through 226 of this chapter. (1) 法(Act) 指联邦食品、药品及化妆品法，修订版(21 U.S.C 301 et seq.)。(1) Act means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.).(2) 批(Batch)指在规定限度内，按照某一生产指令在同一生产周期内生产出来的，具有同一性质和质量的一定数量的药品或其它物料。(3) 组分(Component)指用于药品生产的所有成份，包括那些未在药品中出现的成份。(4) 药品(Drug Product)指成品制剂(如：片剂、胶囊剂、口服液等)，通常含有一种活性成份并伴有非活性成份(但不是必需的)。本术语也包括不含有活性成份但作为安慰剂使用的成品制剂。 (5) 纤维(Fiber) 指长度大于其宽度的3倍的任何微粒状污染物。 (6) 无纤维脱落的过滤器(Non-fiber-releasing filter) 指任何经过适当的预处理(如清洗或冲洗)后，不会将纤维脱落到已过滤的组分或药品中的所有过滤器。所有含石棉过滤器均被认为是有纤维脱落的过滤器。 (7) 活性成份(Active Ingredient) 是指所有用于保证药物活性或其他在疾病的诊断、治愈、缓解、治疗或预防中起直接作用，或影响人或其他动物身体结构或功能的组分。本术语包括那些能承受药品生产中的化学变化和为了保证其指定的活性或作用以一种经调整的形式存在于药品中的组分。 (8) 非活性成份(Inactive ingredient) 指不同于“活性成份”的其他组分。 (9) 中间产品(In-process material) 是指所有经制备、复合、混合或由化学反应得到的用于药品生产或制备的物料。 (10) 批（lot） 指一批或是一批中特定的均一部分，在指定的范围内具有相同的性质和质量；或者若为由连续的生产过程制造出的药品，“批”指在单位时间或单位数量生产出的特定的、均一的部分，并且确保该部分在指定的范围内具有均一性质与质量。 (11) 批号(Lot number, control number，batch number) 指由字母、数字、符号或他们的组合组成，由此可确定某批药品或物料的生产、加工、包装、贮存或销售的情况。 (12) 药品的生产、加工、包装或贮存(Manufacture, processing, packing, or holding of a drug product) 包括药品的包装和标签操作、检验、质量控制。 (13) 药用物料(medicated feed) 指在21CFR 558.3中定义的B型和C型药用物料。该物料含有联邦食品、药品及化妆品法201(g)部分中定义的一种或一种以上的药物，药用物料的生产应符合21CFR 226部分中的要求。 (14) 药用预混合料(medicated premix) 指21CFR 558.3中定义的A型药用物质。该预混合料含有联邦食品、药品及化妆品法201(g)部分中定义的一种或一种以上的药物。药用预混合料生产应符合21CFR 226部分中的要求。 (15) 质量控制部门(Quality control unit) 指由企业任命负责质量控制相关责任的任何人员或组织机构。 (16) 含量或效价（Strength） 指： () 原料药的浓度(如：以重量/重量、重量/体积、单位剂量/体积为基础)；和/(或) () 活性(效价)也即由适当的实验室检测或由足够的临床数据得出的指定的药品治疗活性(如：可表达为对照于某标准的单位的术语)。 (17) 理论产量(Theoretical yield) 指在生产、加工或包装某种药品的任一适当阶段中，并且基于所使用的组分的数量在实际生产中无任何损失或错误的情况下，应能生产的数量。 (18) 实际产量(Actual yield) 指某种药品在生产、加工、包装的任一适当的阶段实际生产出的数量。 (19) 比率(Percentage of theoretical yield) 实际产量(生产、加工或包装某种药品的适当阶段)与理论产量(在相同阶段)的比率，以百分数表示。 (20) 验收标准(Acceptance criteria) 建立在相应的取样方法基础上的药品的质量检验标准和合格、不合格标准(如合格质量水平和不合格的质量水平)，是决定批准或拒收一批(或其他生产单元的小组)药品的必需因素。 (21) 代表性样品(Representative sample)指一个样品按合理的标准抽取（如随机取样法），并包含若干单位（元），以能保证样品准确描绘被取样品的物料。(2) Batch means a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.(3) Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product.(4) Drug product means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.(5) Fiber means any particulate contaminant with a length at least three times greater than its width.(6) Non-fiber-releasing filter means any filter, which after any appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. All filters composed of asbestos are deemed to be fiber-releasing filters.(7) Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.(8) Inactive ingredient means any component other than an active ingredient.(9) In-process material means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product.(10) Lot means a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits.(11) Lot number, control number, or batch number means any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined.(12) Manufacture, processing, packing, or holding of a drug product includes packaging and labeling operations, testing, and quality control of drug products.(13) The term medicated feed means any Type B or Type C medicated feed as defined in 558.3 of this chapter. The feed contains one or more drugs as defined in section 201(g) of the act. The manufacture of medicated feeds is subject to the requirements of Part 225 of this chapter.(14) The term medicated premix means a Type A medicated article as defined in 558.3 of this chapter. The article contains one or more drugs as defined in section 201(g) of the act. The manufacture of medicated premixes is subject to the requirements of Part 226 of this chapter.(15) Quality control unit means any person or organizational element designated by the firm to be responsible for the duties relating to quality control.(16) Strength means:(I) The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis), and/or(ii) The potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard).(17) Theoretical yield means the quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production.(18) Actual yield means the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product.(19) Percentage of theoretical yield means the ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage.(20) Acceptance criteria means the product specifications and acceptance/rejection criteria, such as acceptable quality level and unac