【正文】 分或本章600至680各部分和本部分均可適用的條例，前部分的條例可代替本部分條例。 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 bination of letters, numbers, or symbols, or any bination of them, from which the plete 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 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 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 ponents 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 unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units).(21) Representative sample means a sample that consists of a number of units that are drawn based on rational criteria such as random sampling and intended to assure that the sample accurately portrays the material being sampled.(22) Gangprinted labeling means labeling derived from a sheet of material on which more than one item of labeling is printed.[43 FR 45076, Sept. 29, 1978, as amended at 51 FR 7389, Mar. 3, 1986。39。 (21) 代表性樣品(Representative sample)指一個(gè)樣品按合理的標(biāo)準(zhǔn)抽?。ㄈ珉S機(jī)取樣法），并包含若干單位（元），以能保證樣品準(zhǔn)確描繪被取樣品的物料。 (19) 比率(Percentage of theoretical yield) 實(shí)際產(chǎn)量(生產(chǎn)、加工或包裝某種藥品的適當(dāng)階段)與理論產(chǎn)量(在相同階段)的比率，以百分?jǐn)?shù)表示。 (17) 理論產(chǎn)量(Theoretical yield) 指在生產(chǎn)、加工或包裝某種藥品的任一適當(dāng)階段中，并且基于所使用的組分的數(shù)量在實(shí)際生產(chǎn)中無(wú)任何損失或錯(cuò)誤的情況下，應(yīng)能生產(chǎn)的數(shù)量。 (15) 質(zhì)量控制部門(Quality control unit) 指由企業(yè)任命負(fù)責(zé)質(zhì)量控制相關(guān)責(zé)任的任何人員或組織機(jī)構(gòu)。該預(yù)混合料含有聯(lián)邦食品、藥品及化妝品法201(g)部分中定義的一種或一種以上的藥物。該物料含有聯(lián)邦食品、藥品及化妝品法201(g)部分中定義的一種或一種以上的藥物，藥用物料的生產(chǎn)應(yīng)符合21CFR 226部分中的要求。 (12) 藥品的生產(chǎn)、加工、包裝或貯存(Manufacture, processing, packing, or holding of a drug product) 包括藥品的包裝和標(biāo)簽操作、檢驗(yàn)、質(zhì)量控制。 (10) 批（lot） 指一批或是一批中特定的均一部分，在指定的范圍內(nèi)具有相同的性質(zhì)和質(zhì)量；或者若為由連續(xù)的生產(chǎn)過(guò)程制造出的藥品，“批”指在單位時(shí)間或單位數(shù)量生產(chǎn)出的特定的、均一的部分，并且確保該部分在指定的范圍內(nèi)具有均一性質(zhì)與質(zhì)量。 (8) 非活性成份(Inactive ingredient) 指不同于“活性成份”的其他組分。 (7) 活性成份(Active Ingredient) 是指所有用于保證藥物活性或其他在疾病的診斷、治愈、緩解、治療或預(yù)防中起直接作用，或影響人或其他動(dòng)物身體結(jié)構(gòu)或功能的組分。 (6) 無(wú)纖維脫落的過(guò)濾器(Nonfiberreleasing filter) 指任何經(jīng)過(guò)適當(dāng)?shù)念A(yù)處理(如清洗或沖洗)后，不會(huì)將纖維脫落到已過(guò)濾的組分或藥品中的所有過(guò)濾器。本術(shù)語(yǔ)也包括不含有活性成份但作為安慰劑使用的成品制劑。(3) 組分(Component)指用于藥品生產(chǎn)的所有成份，包括那些未在藥品中出現(xiàn)的成份。(b) The following definitions of terms apply to this part and to Parts 211 through 226 of this chapter. (1) 法(Act) 指聯(lián)邦食品、藥品及化妝品法