欧洲QP协会问答： 公司里授权人的职责

欧洲QP协会问答： 公司里授权人的职责

2014-11-10 09:30:42|  分类： 欧盟知识|举

Role of the Qualified Person in the Company 公司里授权人的职责

Q: Is it possible to name more than one QP for the release of one certain product and if yes, can each QP be named as responsible for different sub-types of the product? 是否可以任命多一位QP放行同一个产品，如果可以，是否可以将不同类型的产品让每个QP都能放行？

A: It is perfectly possible to name more that one QP and they can be named for different sub-types of product.

答：最好是任命不止一个QP，他们可以放行不同类型的产品。

Q: Does the QP have to confirm acceptance of the company’s QA-System in writing or is signing of job descriptions and/or signing key-SOPs sufficient? 授权人是否必须书面确认公司的QA体系的可接受标准，还是说只需要签署工作职责和/或签署关键SOP就可以了？

A: There is absolutely no regulatory or GMP requirement or expectation that a QP has to sign off job descriptions or key SOPs. In addition there is no formal requirement that a QP has to “confirm acceptance” of the company’s QA-System. Pharmaceutical manufactures usually run regular Quality Management Reviews that include a documented management assessment of the suitability of the Quality System. Therefore we would consider it appropriate and adequate that the QP is a regular member of this board.

答：绝对没有法规或GMP要求或期望QP必须签署工作岗位说明书或关键SOP。另外，也没有正式的要求说QP必须“确认公司QA体系的可接受性”。药品生产通常要经过定期质量管理审核，其中包括对质量体系适用性的管理评估，并有记录。因此，我们认为QP是该委员会的常规成员会比较合适，也比较充分。

Q: From a GMP and legal point of view, is there any problem that QP/QA and QC are the same person? 从GMP和法规角度来看，QP/QA和QA由同一个人负责，是否存在问题？

A: The only requirement under GMP is that the person responsible for production and the person responsible for quality control are independent. The QP can be the person who is also responsible for QC or the person who is responsible for QA (or both). In practice the QP certifying batches of product should not be the person who is responsible for their production.

答：GMP只有一个要求，生产负责人和质量控制负责人应相互独立。QP可以同时负责QC和/或QA。在实践中，放行批产品的QP就不负责该产品的生产。

Q: Who should sign the Quality Agreement? The QP only? QA? Legal? Head of production/QC? Business? 应该由谁来签署质量协议？QP单独签署？QA单独签署？法人？生产负责人/QC负责人？商务负责人？

A: Quality Agreements should be considered GMP documents. Therefore involvement of the Legal Departments can be limited. According to the latest revision of chapter 7 of the EU GMP Guide (“Outsourced activities”) ... 7.12 “A contract should be drawn up between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities and communication processes relating to the outsourced activities. Technical aspects of the contract should be drawn up by competent persons suitably knowledgeable in related outsourced activities and Good Manufacturing Practice.”

答：质量协议应被认为是GMP文件。因此，应限制签署的法规部门。根据最新版本EU GMP指南第7章（外包活动）……7.12“合同应由委托方和受托方签署，其中应说明各自的责任，与外包活动相关的沟通流程。合同的技术方面应由有资质在相关外包活动方面具备知识背景和GMP知识的人员签署”。

Chapter 2.7 of the revised chapter 2 of the EU GMP Guide (“Personnel”) states: “The heads of Production and Quality Control generally have some shared, or jointly exercised, responsibilities...— the approval and monitoring of contract manufacturers;”

EU GMP指南的第2章（人员）第2.7节说明：“生产负责人和质量控制负责人一般会有一些共同或联合的工作、职责……---合同生产商的批准和监控”。

Keeping these two chapters in mind, I would advocate for the Head of Production and Quality Control to sign a Quality Agreement. The QP must be informed, but there is no obligation for him/her to sign the Quality Agreement.

如果记住了这两个章节，我会联合生产负责人和质量控制负责人来签署质量协议。必须通知QP，但他/她并没有义务来签署质量协议。

Q: If an audit required by Annex 16 is performed by corporate QA or a global QA function of the same company but part of different legal entity (e.g. from US), will I need a contract or is an SOP sufficient? 如果由同一公司的分公司QA或全球QA根据附录16进行审计，但有一部分是不同的法人主体（例如，美国），我是否需要签订一份合同或有一份SOP就够了？

A: European understanding on different legal entities even within the same global company has to be considered as independent to each other in terms of GMP. According to Chapter 7 EU GMP all services contracted out should be covered by a contract. If such a service is provided to the QP by a global function it should be covered by a contract. Topics to be considered are provisions of influence on sequence, audit agenda, audit reports availability, auditor rating and possibilities to accompany the audit as an auditor.

答：欧洲对不同法定主体的理解是，即使是属一个全球公司，在GMP角度来说，也必须作为相互独立的主体来考虑。根据EU GMP第7章，所有服务外包必须签订合同。如果这种服务是由全球QP提供，则应包括在合同里。要考虑的问题是条款对结果、审计计划、审计报告可获得性、审计人员级别和陪同审计作为审计员的可能性。

Q: Annex 11 states that “There should be close cooperation between all relevant personnel such as Process Owner, System Owner, Qualified Persons and IT. All personnel should have appropriate qualifications, level of access and defined responsibilities to carry out their assigned duties.“ What should be understood by “close cooperation between all relevant personnel …”? What formal requirements should be observed? 附录11中这么说“在所有相关的人员，例如工艺持有人、系统持有人、QP和IT之间应有紧密合同。所有人员均应具备适当资质、权限水平和既定的职责以实施其被赋予的责任。”这里要怎么理解“所有相关人员……之间的紧密合作”？要有什么正式的要求？

A: No defined formal requirements exist for close co-operation between all relevant personnel during validation. But efforts must be made to ensure that a corresponding division of roles and tasks between the relevant personnel is clearly defined and implemented, including IT. (source: ECA Q&A)

答：在验证中，对所有相关人员之的紧密合同并不存在既定的正式要求。但必须努力保证对相关人员，包括IT，进行了清楚的角色分配和任务分配，并实施。

（来源：ECA Q&A  http://zhuyujiao1972.blog.163.com/blog/static/98694727201410109304235/ ）

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