1. 概述
质量受权人（Qualified Person，Authorized Person）的资质：
应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格），具有至少五年从事药品生产和质量管理的实践经验，从事过药品生产过程控制和质量检验工作。应当具有必要的专业理论知识，并经过与产品放行有关的培训，方能独立履行其职责。
质量受权人的主要职责：
1.参与企业质量体系建立、内部自检、外部质量审计、验证以及药品不良反应报告、产品召回等质量管理活动；
2.承担产品放行的职责，确保每批已放行产品的生产、检验均符合相关法规、药品注册要求和质量标准；
3.在产品放行前，质量受权人必须按照上述第2项的要求出具产品放行审核记录，并纳入批记录 。
质量管理负责人（Quality management）的资质：
应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格），具有至少五年从事药品生产和质量管理的实践经验，其中至少一年的药品质量管理经验，接受过与所生产产品相关的专业知识培训。
质量管理负责人的主要职责：
确保产品符合质量标准、批记录的审核、检验、操作规程的批准、变更的审核和批准、偏差和超标的处理、委托检验的批准、厂房和设备维护的监督、确保确认或验证的工作。
2. 法规指南
质量受权人
2.1 国内药监
（
《药品管理法》）
第三十三条 药品上市许可持有人应当建立药品上市放行规程，对药品生产企业出厂放行的药品进行审核，经质量受权人签字后方可放行。 不符合国家药品标准的，不得放行。
第四十七条 药品生产企业应当对药品进行质量检验。不符合国家药品标准的，不得出厂。
药品生产企业应当建立药品出厂放行规程，明确出厂放行的标准、条件。 符合标准、条件的，经质量受权人签字后方可放行。
第六条 从事药品生产，应当符合以下条件：
（一）有依法经过资格认定的药学技术人员、工程技术人员及相应的技术工人，法定代表人、企业负责人、生产管理负责人（以下称生产负责人）、质量管理负责人（以下称质量负责人）、质量受权人及其他相关人员符合《药品管理法》《疫苗管理法》规定的条件；
第十四条 药品生产许可证应当载明许可证编号、分类码、企业名称、统一社会信用代码、住所（经营场所）、法定代表人、企业负责人、生产负责人、质量负责人、质量受权人、生产地址和生产范围、发证机关、发证日期、有效期限等项目。
第二十八条 药品上市许可持有人的法定代表人、主要负责人应当对药品质量全面负责，履行以下职责：
（二）配备专门质量受权人独立履行药品上市放行责任；
第二十九条 药品生产企业的法定代表人、主要负责人应当对本企业的药品生产活动全面负责，履行以下职责：
（二）配备专门质量受权人履行药品出厂放行责任；
第三十七条 药品生产企业应当建立药品出厂放行规程，明确出厂放行的标准、条件，并对药品质量检验结果、关键生产记录和偏差控制情况进行审核，对药品进行质量检验。符合标准、条件的，经质量受权人签字后方可出厂放行。
药品上市许可持有人应当建立药品上市放行规程，对药品生产企业出厂放行的药品检验结果和放行文件进行审核，经质量受权人签字后方可上市放行。
第四十五条 药品上市许可持有人、药品生产企业的质量管理体系相关的组织机构、企业负责人、生产负责人、质量负责人、质量受权人发生变更的，应当自发生变更之日起三十日内，完成登记手续。
疫苗上市许可持有人应当自发生变更之日起十五日内，向所在地省、自治区、直辖市药品监督管理部门报告生产负责人、质量负责人、质量受权人等关键岗位人员的变更情况。
第二十条 关键人员应当为企业的全职人员，至少应当包括企业负责人、生产管理负责人、质量管理负责人和质量受权人。
质量管理负责人和生产管理负责人不得互相兼任。质量管理负责人和质量受权人可以兼任。应当制定操作规程确保质量受权人独立履行职责，不受企业负责人和其他人员的干扰。
第二十五条 质量受权人
（一）资质：
质量受权人应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格），具有至少五年从事药品生产和质量管理的实践经验，从事过药品生产过程控制和质量检验工作。
质量受权人应当具有必要的专业理论知识，并经过与产品放行有关的培训，方能独立履行其职责。
（二）主要职责：
1.参与企业质量体系建立、内部自检、外部质量审计、验证以及药品不良反应报告、产品召回等质量管理活动；
2.承担产品放行的职责，确保每批已放行产品的生产、检验均符合相关法规、药品注册要求和质量标准；
3.在产品放行前，质量受权人必须按照上述第2项的要求出具产品放行审核记录，并纳入批记录。
（三）GMP中提到的质量受权人其他相关职责：
2.2 欧盟
Directive 2001/83/EC
(ia) A summary of the applicant's pharmacovigilance system which shall include the following elements:
— proof that the applicant has at his disposal a qualified person responsible for pharmacovigilance,
— the Member States in which the qualified person resides and carries out his/her tasks,
— the contact details of the qualified person
欧盟GMP通则 第二章 人员
2.6 质量受权人的职责在第2001/83/EC号法令的第51条中已经描述，现概述如下：
(a) 在欧盟辖区内生产的药品，质量受权人必须确保每批药品都按成员国现行法律和上市许可进行生产和检査；
(b) 如果药品来自第三国，无论药品是否曾在欧盟生产，质量受权人必须确保每个生产批次已经在某一成员国进行了全面定性分析，至少对所有的活性物质进行了定量分析，并进行其他必要的检测或检查，从而确保药品质量符合上市许可要求。产品放行前，质量受权人必须通过登记或等效文件来签发证明，如果签发了此证明，每个生产批次均符合第2001/83/EC号法令第51条的规定。
承担该职责的人员必须符合2001/83/EC号法令第49条所规定的资质要求，他们应当长期并持续地接受上市许可持有人的安排，从而履行其职责。
质量受权人职责可以委托，但只能委托给其他的质量受权人。（有关质量受权人岗位的指南在附录16中有详细描述。）
欧盟GMP 附录16 药品质量受权人签发证书和放行批产品
范围
本附录提供了有关欧盟内持有上市许可（MA）或供出口的人用药品或兽用药品的质量受权人认证以及批放行的指导。本指南的原则也适用于人用临床试验用药（IMP），但需遵循法律条款以及欧盟委员会已发布的更具体指南的差异。
经修订后的第2001/83/EC号指令第51条和第2001/82/EC号指令第55条提供了有关立法要求。注意参考经修订后的第2001/83/EC号指令第51(2)条以及第2001/82/EC指令第55(2)条，例如互认协议(MRA)。
本附录未涉及根据修订的第2001/83/EC号指令第109、110、113和114条以及第2001/82/EC号指令的第81条与82条为某些血液和免疫产品指定的“官方控制机构批放行”。 但是，本附录适用于此类批次的QP认证和后续放行。
产品批放行的基本要求由其上市许可所规定。 本附录中的任何内容均不应被视为凌驾于上市许可的基本要求之上。
欧盟GMP 附录21 药品进口
2. Principles
2.1. For the purpose of this annex, the term importation refers to the action of physically bringing a medicinal product, from outside the territory of EEA/EU; fiscal transactions are not part of this annex. Qualified Person (QP) certification or confirmation, as appropriate, of a batch of a medicinal product takes place only after physical importation and custom clearance into the customs territory of an EU/EEA State.
2.4. The Qualified Person certifying the batch must ensure that all the medicinal products for human or veterinary use or investigational medicinal products that are imported into the Union from a third country were manufactured in accordance with the EU GMP Guide or recognised equivalent standards, and for products with a marketing authorisation, tested upon importation in the Union , unless there are appropriate arrangements in place between the Union and the third country (e.g. Mutual Recognition Agreement (MRA) or Agreement on conformity assessment and acceptance of industrial products, ACAA). See also Annex 16 of the EU GM] Guide and Annex 13, the detailed guidelines on GMP for Investigational Medicinal Products (IMPs) for further guidance.
EMA GMP 和 MAH 思考性文件
值得注意的是，正如GMP指南附件16中所指出的那样，药品在其生命周期内的性能、安全性、质量和有效性的最终责任在于MAH。（这并没有改变这样一个事实，同样根据附件 16，质量受权人 (QP) 负责确保每个批次的生产和检查均符合进行认证的成员国的现行法律，这也符合上市许可 (MA) 和GMP的要求。）
2.3 WHO
9.11 The authorized person is responsible for compliance with technical or regulatory requirements related to the quality of finished products and the approval of the release of the finished product for sale.
9.14 The authorized person responsible for approving a batch for release should always ensure that the following requirements have been met:
(a) the marketing authorization and the manufacturing authorization requirements for the product have been met for the batch concerned;
(b) the principles and guidelines of GMP, as laid down in the guidelines published by WHO, have been followed;
(c) the principal manufacturing and testing processes have been validated, if different;
(d) all the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records;
(e) any planned changes or deviations in manufacturing or quality control have been notified in accordance with a well defined reporting system before any product is released . Such changes may need notification to, and approval by, the medicines regulatory authority;
(f) any additional sampling, inspection, tests and checks have been carried out or initiated, as appropriate, to cover planned changes and deviations ;
(g) all necessary production and quality control documentation has been completed and endorsed by supervisors trained in appropriate disciplines;
(h) appropriate audits, self-inspections and spot-checks are carried out by experienced and trained staff;
(i) approval has been given by the head of quality control;
(j) all relevant factors have been considered, including any not specifically associated with the output batch directly under review (e.g. subdivision of output batches from a common input, factors associated with continuous production runs).
2.4 PIC/S
PIC/S GMP 附录16 质量受权人和批放行
This Annex provides guidance on the certification by an Authorised Person and on batch release of medicinal products for human or veterinary use within a Pharmaceutical Inspection Co-operation Scheme (PIC/S) Participating Authority or made for export. The principles of this guidance also apply to investigational medicinal products (IMP) for human use, subject to any difference in the legal provisions and more specific guidance published by PIC/S Participating Authorities under national law.
质量负责人
2.5 法规指南
FDA CFR 211 Subpart B--Organization and Personnel
Sec. 211.22 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 components, drug product containers, closures, in-process 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 company.
(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging material, in-process 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. 211.25 Personnel qualifications. WL1.png
(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 combination 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.
中国GMP 第三章 机构与人员
第二十三条 质量管理负责人
（一）资质：
质量管理负责人应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格），具有至少五年从事药品生产和质量管理的实践经验，其中至少一年的药品质量管理经验，接受过与所生产产品相关的专业知识培训。
（二）主要职责：
1.确保原辅料、包装材料、中间产品、待包装产品和成品符合经注册批准的要求和质量标准；
2.确保在产品放行前完成对批记录的审核；
3.确保完成所有必要的检验；
4.批准质量标准、取样方法、检验方法和其他质量管理的操作规程；
5.审核和批准所有与质量有关的变更；
6.确保所有重大偏差和检验结果超标已经过调查并得到及时处理；
7.批准并监督委托检验；
8.监督厂房和设备的维护，以保持其良好的运行状态；
9.确保完成各种必要的确认或验证工作，审核和批准确认或验证方案和报告；
10.确保完成自检；
11.评估和批准物料供应商；
12.确保所有与产品质量有关的投诉已经过调查，并得到及时、正确的处理；
13.确保完成产品的持续稳定性考察计划，提供稳定性考察的数据；
14.确保完成产品质量回顾分析；
15.确保质量控制和质量保证人员都已经过必要的上岗前培训和继续培训，并根据实际需要调整培训内容。
EU GMP Chapter 2 Personnel
2.8 The head of the Quality Control generally has the following responsibilities:
i. to approve or reject, as he sees fit, starting materials, packaging materials, intermediate, bulk and finished products;
ii. To ensure that all necessary testing is carried out and the associated records evaluated;
iii. to approve specifications, sampling instructions, test methods and other Quality Control procedures ;
iv to approve and monitor any contract analysts;
v. to ensure the qualification the maintenance of his department, premises and equipment;
vi. to ensure that the appropriate validations are done;
vii. to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
Other duties of the Quality Control Department are summarised in Chapter 6.
WHO GMP 9.Personnel
9.8 The heads of the production and quality control generally have some shared, or jointly exercised, responsibilities relating to quality. These may include, depending on national regulations: (a) authorization of written procedures and other documents, including amendments;
(b) monitoring and control of the manufacturing environment;
(c) plant hygiene;
(d) process validation and calibration of analytical apparatus;
(e) training, including the application and principles of quality assurance;
(f) approval and monitoring of suppliers of materials;
(g) approval and monitoring of contract manufacturers;
(h) designation and monitoring of storage conditions for materials and products;
(i) performance and evaluation of in-process controls;
(j) retention of records;
(k) monitoring of compliance with GMP requirements;
(l) inspection, investigation and taking of samples in order to monitor factors that may affect product quality.
