受托生产管理规程

Juggernaut

各位蒲友，背景如下：本公司作为受托方，需要接受集团内另一家子公司的委托生产需求，生产产品是临床前产品。目前需要建立一份《受托生产管理规程》，看了下《药品委托生产质量协议指南（2020年版）》、《药品委托生产监督管理规定》，包括我们公司内部的《委托生产管理规程》，感觉对委托生产倒是明白了，但是针对受托的思路还不太清晰，想请教一下各位同仁，给点启发，谢谢

fireflame

受托方就是一家获得c证的GMP生产厂，与委托方通过协议分配各自的职责。但是受托企业基本就是一家职能完整的GMP工厂

爱上唯蓝

你把自己当供应商，你的体系要完整并受到委托方的审核；关键文件、关键事项均需要有委托方的审核批准；提供委托方需要的资料数据；有异常、变更、审计等等需要考虑对委托产品的影响，并通知委托方；配合委托方的药物警戒、召回、官方审计等等事项，个人理解仅供参考

Juggernaut

爱上唯蓝 发表于 2023-1-13 16:04
你把自己当供应商，你的体系要完整并受到委托方的审核；关键文件、关键事项均需要有委托方的审核批准；提供 ...

恩恩，谢谢回复，您说的这些需要被考虑进去，作为文件整体中各个板块进行分别规定，感谢

猫咪特工

1、对于受托而言，需要反馈质量协议的诉求，反馈生产检验信息，如何保证反馈准确、及时，如何保证数据审核流程

2、物料流转、和委托方相关的文件变更偏差签批流程、档案管理流程

3、发生质量事件，应如何应急处理

bj02

临床前产品？有必要的风险评估、职责分工、生产方案就差不多了吧

Juggernaut

bj02 发表于 2023-1-16 09:40
临床前产品？有必要的风险评估、职责分工、生产方案就差不多了吧

风评，职责肯定是有的，目前需要起草生产管理规程

Juggernaut

木木杨1 发表于 2023-1-13 18:14
1、对于受托而言，需要反馈质量协议的诉求，反馈生产检验信息，如何保证反馈准确、及时，如何保证数据审核 ...

您说的部分内容应该会在协议里体现，我目前比较关注生产管理

流年似水m4x

协议中规定

Hush1

文件修订好了吗，能否相互借鉴学习下？

阿庆1

下载学习一下，谢谢了

大饼先生～

请问文件内容理清楚了吗

gk87

按你们签订的质量协议和委托生产合同内容内容起草即可

纵横天下

Hush1 发表于 2023-3-10 14:22
文件修订好了吗，能否相互借鉴学习下？

同求，能否同步分享一下《受托生产管理规程》，我们也学习一下，十分感谢

有时候1

FDA cGMP 16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES) 合同生产商（包括实验室）
• 16.10 All contract manufacturers (including laboratories) should comply with the GMP defined in this guidance. Special consideration should be given to
the prevention of cross-contamination and to maintaining traceability.
• 所有协议生产商（包括实验室）应当遵循本指南所规定的GMP。特别应当注意防止交叉污染，并保持可追溯性。
• 16.11 Companies should evaluate any contractors (including laboratories) to ensure GMP compliance of the specific operations occurring at the contractor
sites.
• 合同委托方应当对协议生产商（包括实验室）进行评估，以确保在合同地点发生的特定操作符合GMP。
• 16.12 There should be a written and approved contract or formal agreement between a company and its contractors that defines in detail the GMP
responsibilities, including the quality measures, of each party.
• 合同委托方与受托方之间应当有经过认定的书面合同或正式协议书，详细规定各方的GMP责任，包括质量措施。
• 16.13 A contract should permit a company to audit its contractor’s facilities for compliance with GMP.
• 合同应当允许合同委托方对受托方的设施进行GMP审计。
• 16.14 When subcontracting is allowed, a contractor should not pass to a third party any of the work entrusted to it under the contract without the company’s
prior evaluation and approval of the arrangements.
• 在允许分包的情况下，未经合同委托方事先的评估和核准，受托方不应当将合同中委托给他的工作转交给第三方。
• 16.15 Manufacturing and laboratory records should be kept at the site where the activity occurs and be readily available.
• 生产和分析记录应当保存在操作现场，并随时可得。
• 16.16 Changes in the process, equipment, test methods, specifications, or other contractual requirements should not be made unless the contract giver is
informed and approves the changes.
• 应当在通知合同委托方，并得到批准后，才可以对工艺、设备、测试方法、规格标准或其它合同要求进行变更

有时候1

NMPA GMP 第十一章　委托生产与委托检验
•　　第二百七十八条　为确保委托生产产品的质量和委托检验的准确性和可靠性，委托方和受托方必须签订书面合同，明确规定各方责任、委托生产或委托检验的内容及相关的技术事项。
•　　第二百七十九条　委托生产或委托检验的所有活动，包括在技术或其他方面拟采取的任何变更，均应当符合药品生产许可和注册的有关要求。
第一节　原　则
•　　第二百八十条　委托方应当对受托方进行评估，对受托方的条件、技术水平、质量管理情况进行现场考核，确认其具有完成受托工作的能力，并能保证符合本规范的要求。
•　　第二百八十一条　委托方应当向受托方提供所有必要的资料，以使受托方能够按照药品注册和其他法定要求正确实施所委托的操作。　　委托方应当使受托方充分了解与产品或操作相关
的各种问题，包括产品或操作对受托方的环境、厂房、设备、人员及其他物料或产品可能造成的危害。
•　　第二百八十二条　委托方应当对受托生产或检验的全过程进行监督。
•　　第二百八十三条　委托方应当确保物料和产品符合相应的质量标准。
第二节　委托方
•　　第二百八十四条　受托方必须具备足够的厂房、设备、知识和经验以及人员，满足委托方所委托的生产或检验工作的要求。
•　　第二百八十五条　受托方应当确保所收到委托方提供的物料、中间产品和待包装产品适用于预定用途。
•　　第二百八十六条　受托方不得从事对委托生产或检验的产品质量有不利影响的活动。
第三节　受托方
•　　第二百八十七条　委托方与受托方之间签订的合同应当详细规定各自的产品生产和控制职责，其中的技术性条款应当由具有制药技术、检验专业知识和熟悉本规范的主管人员拟订。委托
生产及检验的各项工作必须符合药品生产许可和药品注册的有关要求并经双方同意。
•　　第二百八十八条　合同应当详细规定质量受权人批准放行每批药品的程序，确保每批产品都已按照药品注册的要求完成生产和检验。
•　　第二百八十九条　合同应当规定何方负责物料的采购、检验、放行、生产和质量控制（包括中间控制），还应当规定何方负责取样和检验。在委托检验的情况下，合同应当规定受托方是
否在委托方的厂房内取样。
•　　第二百九十条　合同应当规定由受托方保存的生产、检验和发运记录及样品，委托方应当能够随时调阅或检查；出现投诉、怀疑产品有质量缺陷或召回时，委托方应当能够方便地查阅所
有与评价产品质量相关的记录。
•第二百九十一条　合同应当明确规定委托方可以对受托方进行检查或现场质量审计。
•第二百九十二条　委托检验合同应当明确受托方有义务接受药品监督管理部门检查

有时候1

EU GMP Chapter 7 Outsourced Activities
• Principle原则
• Any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed and controlled in order to avoid
misunderstandings which could result in a product or operation of unsatisfactory quality. There must be a written Contract between the Contract
Giver and the Contract Acceptor which clearly establishes the duties of each party. The Quality Management System of the Contract Giver must
clearly state the way that the Qualified Person certifying each batch of product for release exercises his full responsibility.
• GMP指南所涵盖的任何外包活动都应得到适当的定义、同意和控制，以避免可能导致产品或操作质量不满意的误解。在合同委托方
和受托方之间必须有一份书面合同，明确规定了双方的责任。合同委托方的质量管理体系必须明确说明放行每批产品的合格人员履行
其全部责任的方式。
• Note: This Chapter deals with the responsibilities of manufacturers towards the Competent Authorities of the Member States with respect to the
granting of marketing and manufacturing authorizations. It is not intended in any way to affect the respective liability of Contract Acceptors and
Contract Givers to consumers; this is governed by other provisions of Community and national law.
• 注:本章涉及制造商对成员国主管当局在批准销售和生产许可方面的责任。它不打算以任何方式影响合同受托方和合同委托方对消费
者的各自责任;这由共同体和国家法律的其他规定管辖

有时候1

The Contract Acceptor 受托方
• 7.9 The Contract Acceptor must be able to carry out satisfactorily the work ordered by the Contract Giver such as having adequate premises,
equipment, knowledge, experience, and competent personnel.受托方必须有足够的场地、设备、知识、经验和有能力的人员，能够令人满
意地进行委托方所要求的工作。
• 7.10 The Contract Acceptor should ensure that all products, materials and knowledge delivered to him are suitable for their intended purpose.受
托方应确保交付给其的所有产品、材料和知识都适合其预期用途。
• 7.11 The Contract Acceptor should not subcontract to a third party any of the work entrusted to him under the Contract without the Contract
Giver’s prior evaluation and approval of the arrangements. Arrangements made between the Contract Acceptor and any third party should ensure
that information and knowledge, including those from assessments of the suitability of the third party, are made available in the same way as
between the original Contract Giver and Contract Acceptor.未经委托方事先评估和同意，受托方不得将本合同委托的任何工作分包给第三
方。受托方与任何第三方之间的安排应确保信息和知识，包括来自对第三方的适当性评估的信息和知识，以原合同给予方与受托方之
间相同的方式提供。
• 7.12 The Contract Acceptor should not make unauthorized changes, outside the terms of the Contract, which may adversely affect the quality of
the outsourced activities for the Contract Giver.受托方不得擅自在合同条款之外做出可能对发包方外包活动质量产生不利影响的变更。
• 7.13 The Contract Acceptor should understand that outsourced activities, including contract analysis, may be subject to inspection by the
competent authorities.受托方应了解，外包活动，包括受托检验，可能会受到主管部门的检查

有时候1

The Contract 合同
• 7.14 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. All arrangements for outsourced activities must be in
accordance with regulations in force and the Marketing Authorisation for the product concerned and agreed by both parties.在合同委托方和合
同受托方之间应制定一份合同，明确各自与外包活动有关的责任和沟通过程。合同的技术方面应由具有相关外包活动和良好生产规范
相关知识的胜任人员制定。所有外包活动的安排必须符合有效的法规和相关产品的上市许可，并经双方同意。
• 7.15 The Contract should describe clearly who undertakes each step of the outsourced activity, e.g. knowledge management, technology transfer,
supply chain, subcontracting, quality and purchasing of materials, testing and releasing materials, undertaking production and quality controls
(including in-process controls, sampling and analysis).合同应清楚地描述由谁承担外包活动的每一步，例如:知识管理、技术转让、供应
链、分包、材料的质量和采购、检测和发放材料、进行生产和质量控制(包括过程控制、抽样和分析)。
• 7.16 All records related to the outsourced activities, e.g. manufacturing, analytical and distribution records, and reference samples, should be
kept by, or be available to, the Contract Giver. Any records relevant to assessing the quality of a product in the event of complaints or a
suspected defect or to investigating in the case of a suspected falsified product must be accessible and specified in the relevant procedures of the
Contract Giver.与外包活动有关的所有记录，如制造、分析和分发记录以及参考样品，应由委托方保存或提供给委托方。在投诉或疑
似缺陷情况下评估产品质量或在疑似伪造产品情况下进行调查的任何记录必须可获得并在合同授予方的相关程序中加以规定。
• 7.17 The Contract should permit the Contract Giver to audit outsourced activities, performed by the Contract Acceptor or his mutually agreed
subcontractors合同应允许委托方对由合同接受方或双方同意的分包方实施的外包活动进行审计

馨兰

请问文件是否已经修订，是否可以借鉴参考一下