【正文】 aracter 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) Nonfiberreleasing filter means any filter, which after any appropriate pretreatment such as washing or flushing, will not release fibers into the ponent or drug product that is being filtered. All filters posed of asbestos are deemed to be fiberreleasing filters.(7) Active ingredient means any ponent 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 ponents 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 ponent other than an ``active ingredient.39。(9) Inprocess material means any material fabricated, pounded, 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。 58 FR 41353, Aug. 3, 1993]EFFECTIVE DATE NOTE: At 58 FR 41353, Aug. 8, 1993, was amended by adding paragraph (b)(22) effective Aug. 3, 1994.A． 總 則Subpart AGeneral Provisions211?1范圍（a） 本部分的條例包含人用或獸用藥品制備的現(xiàn)行最低限度的藥品生產(chǎn)質(zhì)量管理規(guī)范（GMP）（b） 在本章里的這些針對藥品的現(xiàn)行GMP條例和本章600至800的所有部分針對人用生物制品的現(xiàn)行GMP條例，除非明確另有說明者外，應(yīng)認(rèn)為是對本部分條例的補充，而是不代替。（c） 在考慮經(jīng)提議的，發(fā)表在1978年9月29日聯(lián)邦注冊表（FR）上一項免除時，若產(chǎn)品及其所有成份是以人用物品形式作一般銷售和消費且這些產(chǎn)品根據(jù)其預(yù)期用途，亦可列入藥品的范圍內(nèi)，則不應(yīng)對這些非處方藥（OTC）實施本部分條例，直至進(jìn)一步的通知為止。Sec. Scope. (a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals. (b) The current good manufacturing practice regulations in this chapter as they pertain to drug products。 and in part 1271 of this chapter, as they are applicable to drugs that are also human cells, tissues, and cellular and tissuebased products (HCT/Ps) and that are drugs (subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act)。Sec. Definitions. The definitions set forth in of this chapter apply in this part.B．組織與人員211?22質(zhì)量控制部門的職責(zé)（a） 本部門有批準(zhǔn)和拒收所有成份、藥品包裝容器、密封件、中間體、包裝材料、標(biāo)簽及藥品的職責(zé)與權(quán)力。本部門負(fù)責(zé)根據(jù)合同，批準(zhǔn)或拒收由其它公司生產(chǎn)、加工、包裝或貯存的藥品。（c） 本部門有批準(zhǔn)或駁回影響藥品的均一性、效價或含量、質(zhì)量及純度的所有程序或規(guī)格標(biāo)準(zhǔn)的職責(zé)。211?25人員資格（a） 每位從事藥品生產(chǎn)、加工、包裝或倉貯工作人員，應(yīng)接受培訓(xùn)、教育及有實踐經(jīng)驗，完成委派的各項職務(wù)。邀請合格人員指導(dǎo)，并連續(xù)多次培訓(xùn)，保證雇員熟悉現(xiàn)行GMP對他們的要求。以此作為提供藥品具有安全性、均一性、效價或含量、質(zhì)量及純度的保證。211?28人員職責(zé)（a） 從事藥品生產(chǎn)、加工、包裝或倉貯的人員，應(yīng)穿著適合于其履行職責(zé)的清潔衣服。（b） 人員保持良好的個人衛(wèi)生和健康。（d） 任何人，在任何時間，明顯地表現(xiàn)出現(xiàn)有影響藥品安全性和質(zhì)量的疾病或開放性`損傷，應(yīng)避免接觸各種成份、藥品容器、包裝設(shè)備、密封件、中間體，直至監(jiān)督人員結(jié)對藥品有不利影響的健康情況。顧問應(yīng)對藥品生產(chǎn)、加工、包裝或倉貯提出建議，他們受過足夠的教育、培訓(xùn)，且有豐富的實踐經(jīng)驗。Subpart BOrganization and Personnel Sec. Responsibilities of quality control unit. (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all ponents, drug product containers, closures, inprocess materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another pany. (b) Adequate laboratory facilities for the testing and approval (or rejection) of ponents, drug product containers, closures, packaging materials, inprocess materials, and drug products shall be available to the qualit