【正文】 (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。 supplement and do not supersede the regulations in this part unless the regulations explicitly provide otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, or in parts 600 through 680 of this chapter, or in part 1271 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general. (c) Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use. Therefore, until further notice, regulations under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice.211?3定義本章210?3中的定義適用于本部分。培訓(xùn)是按照現(xiàn)行GMP（包括本章中的現(xiàn)行GMP條例和這些條例要求的成文程序）中涉及雇員的內(nèi)容。（c） 未經(jīng)監(jiān)督人員允許，其他人員不能進(jìn)入限制進(jìn)入的建筑物和設(shè)施。（b） 建筑物有足夠空間來有條理地安裝設(shè)備和放置材料，避免不同類的成份、藥品容器、密封件、標(biāo)簽、中間體或藥品等相互混放，防止污染。（4） 中間體的貯存。（d）青霉素生產(chǎn)、加工及包裝設(shè)備與生產(chǎn)其他人用藥品的設(shè)備分開。211?48管件（a） 在持續(xù)正壓下，應(yīng)對(duì)藥品無污染的管道系統(tǒng)內(nèi)供應(yīng)飲用水。垃圾和有機(jī)廢料，定時(shí)以衛(wèi)生的方法控制處理。 (2) Holding rejected ponents, drug product containers, closures, and labeling before disposition。 (10) Aseptic processing, which includes as appropriate: (i) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable。 (iii) An air supply filtered through highefficiency particulate air filters under positive pressure, regardless of whether flow is laminar or nonlaminar。 (4) Storage of inprocess materials。（c） 填寫適用的殺鼠劑、殺昆蟲劑、殺真菌劑、熏蒸劑、去垢劑和消毒劑一覽表。不符合該標(biāo)準(zhǔn)的水，不許進(jìn)入水系統(tǒng)。211?46通風(fēng)、空氣過濾、空氣加熱與冷卻（a） 提供足夠的通風(fēng)。（6） 包裝和貼標(biāo)簽操作。（c） 操作應(yīng)在明確規(guī)定的、大小適中的地區(qū)內(nèi)進(jìn)行。211?34顧問為了對(duì)問題提出意見，聘請(qǐng)顧問。（b） 負(fù)責(zé)監(jiān)督藥品的生產(chǎn)、加工、包裝或倉貯工作的每一個(gè)工作人員，應(yīng)受教育、培訓(xùn)及有經(jīng)驗(yàn)，完成委派的各項(xiàng)職務(wù)。復(fù)查生產(chǎn)記錄和權(quán)力，保證不產(chǎn)生差錯(cuò)，或若發(fā)生差錯(cuò)，保證他們充分調(diào)查這差錯(cuò)。本章其他部分或本章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。 (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。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。 (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