【文章內(nèi)容簡介】 Public Health Service Act)。 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。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。復(fù)查生產(chǎn)記錄和權(quán)力，保證不產(chǎn)生差錯，或若發(fā)生差錯，保證他們充分調(diào)查這差錯。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。（b） 適當(dāng)?shù)膶?shí)驗(yàn)室檢驗(yàn)設(shè)備、批準(zhǔn)（或拒收）各種成份、藥品容器、密封件、包裝材料及藥品，質(zhì)量控制部門是可以獲得的。（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)。（d） 適用于本部門的職責(zé)與程序，應(yīng)成文字材料，并應(yīng)遵循。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(shí)踐經(jīng)驗(yàn)，完成委派的各項(xiàng)職務(wù)。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。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。（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)。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。（c） 有足夠量招待和監(jiān)督每種藥品的生產(chǎn)、加工、包裝或倉貯的合格人員。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。按需要，頭部、臉部、手部、臂部另外罩，防止藥物受污染。（b） 人員保持良好的個人衛(wèi)生和健康。（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。（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。211?34顧問為了對問題提出意見，聘請顧問。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(shí)踐經(jīng)驗(yàn)。保留他們的姓名、地址、任何的顧問資格及服務(wù)形式等履歷資料。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。 such written procedures shall be followed. Sec. Personnel qualifications. (a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any bination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee39。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, train