【正文】 han 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(duì)藥品的現(xiàn)行GMP條例和本章600至800的所有部分針對(duì)人用生物制品的現(xiàn)行GMP條例，除非明確另有說(shuō)明者外，應(yīng)認(rèn)為是對(duì)本部分條例的補(bǔ)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(cè)表（FR）上一項(xiàng)免除時(shí)，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(fèi)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(duì)這些非處方藥（OTC）實(shí)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(jià)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(cāng)貯工作人員，應(yīng)接受培訓(xùn)、教育及有實(shí)踐經(jīng)驗(yàn)，完成委派的各項(xiàng)職務(wù)。邀請(qǐng)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(duì)他們的要求。以此作為提供藥品具有安全性、均一性、效價(jià)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(cāng)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(gè)人衛(wèi)生和健康。（d） 任何人，在任何時(shí)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(duì)藥品有不利影響的健康情況。顧問應(yīng)對(duì)藥品生產(chǎn)、加工、包裝或倉(cāng)貯提出建議，他們受過足夠的教育、培訓(xùn)，且有豐富的實(shí)踐經(jīng)驗(yàn)。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 quality control unit. (c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product. (d) The responsibilities and procedures applicable to the quality control unit shall be in writing。s functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. (b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any bination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. (c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product. Sec. Personnel responsibilities. (a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. (b) Personnel shall practice good sanitation and health habits. (c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limitedaccess areas. (d) Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with ponents, drug product containers, closures, inprocess materials, and drug products until the condition is corrected or determined by petent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products. Sec. Consultants. Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any bination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide. C．廠房和設(shè)施211?42設(shè)計(jì)與建造特征（a） 任何用于某類藥品生產(chǎn)、加工、包裝或貯存的廠房或建筑群，大小適宜，結(jié)構(gòu)與位置使其易于清潔、保養(yǎng)、適合操作。通過廠房的上述物料其流向在設(shè)計(jì)時(shí)要防止污染。這些地區(qū)內(nèi)進(jìn)行。下列操作須在單獨(dú)的地區(qū)內(nèi)進(jìn)行：（1） 發(fā)放給生產(chǎn)或包裝前，質(zhì)量控制部門取樣期間，成份、藥品容器、密封件及標(biāo)簽的簽收、鑒別、貯存及拒收。（3） 已發(fā)放的成份、藥品容器、密封件及標(biāo)簽的貯存。（5） 生產(chǎn)與加工操作。（7） 藥品發(fā)放前的隔離貯存。（9） 控制室與實(shí)驗(yàn)室操作。（Ⅰ）地板、墻壁和天花板平滑、堅(jiān)硬、表面易清潔；（Ⅱ）溫度與濕度控制（Ⅲ）空氣經(jīng)高效過濾器、在正壓下過濾、層流或非層流均可；（Ⅳ）環(huán)境監(jiān)測(cè)系統(tǒng)；（Ⅴ）創(chuàng)造無(wú)菌環(huán)境、房間和設(shè)備清潔、消毒系統(tǒng)；（Ⅵ）控制無(wú)菌環(huán)境的設(shè)備維修系統(tǒng)。211?44照明所有地區(qū)均須提供充足的照明。（b） 提供足夠能控制空氣正壓、微生物、塵土、溫度和濕度的設(shè)備，適應(yīng)藥品生產(chǎn)、