生产管理 质量管理 设备 召回 质量管理其他

最全合集!【自检与审计】法规解读、资料、课程内容合集

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1. 概述

自检(Self-inspection,内部审计):是企业自我发现缺陷并主动采取措施进行改进的一系列活动。
企业通过组织自检,可以及时发现缺陷和隐患,主动防范质量风险的发生,确保产品质量稳定可靠,并避免违规事件的发生和发展。一个有效的自检系统,包括:自检程序、自检计划、自检人员的资格确认、检查记录、自检报告、CAPA等。
在法规部门进行的GMP检查中,针对企业的内部自检,国际上一般通行的做法是,监管当局的GMP检查员要求企业证明其已经建立自检系统,但一般并不查看企业内部自检报告的具体内容,以鼓励制药企业开展严格有效的自检活动。有特殊原因时可以例外(例如该制药企业涉嫌造假或其它违法行为)。
审计(Audit,inspection):制药企业经常需要接受来自法规部门、客户等的检查。如果能够建立一个关于如何组织、接待此类检查的程序,则可以保证外部检查的顺利进行,防止因企业内部组织失误,给检察官带来误解,从而导致不良检查结果的发生。

2. 法规合集

2.1 自检

第十三章 自检
第一节 原则
第三百零六条 质量管理部门应当定期组织对企业进行自检,监控本规范的实施情况,评估企业是否符合本规范要求,并提出必要的纠正和预防措施。
第二节 自检
第三百零七条 自检应当有计划,对机构与人员、厂房与设施、设备、物料与产品、确认与验证、文件管理、生产管理、质量控制与质量保证、委托生产与委托检验、产品发运与召回等项目定期进行检查。
第三百零八条 应当由企业指定人员进行独立、系统、全面的自检,也可由外部人员或专家进行独立的质量审计。
第三百零九条 自检应当有记录。自检完成后应当有自检报告,内容至少包括自检过程中观察到的所有情况、评价的结论以及提出纠正和预防措施的建议。自检情况应当报告企业高层管理人员。
IV 质量体系模型
D 评估活动
2 进行内部审计
质量体系方法要求按计划时间间隔进行审计,以评估质量体系是否有效贯彻和保持,确定工艺和产品是否符合既定参数和标准。与其它程序相同,必需建立审计程序并以文件形式记录,以确保计划的审计安排考虑到了各种质量体系活动的相关风险、上次审计和纠正措施的结果,以及是否需要审计整个体系。程序应当描述在客观证据收集、检查员职责以及审计程序等方面怎样对审计员进行培训。 同时审计程序应当详细说明审计活动,比如审计范围、审计方法、审计员的选择和如何实施审计(审计计划、首次会议、面谈、末次会议以及审计报告)等内容。 记录审计发现的问题和制定下一步工作职责对于预防问题再次发生来说是非常重要的(见IV.D.3)。
质量体系模型要求负责审计区域的管理者要及时采取措施来解决审计发现的问题,并确保后续工作的完成、核实和记录。(根据合规政策指南 130.300.19, FDA的政策是克制审核和复制内部审计所得出的报告或记录。)
Article 14 Self-inspection
The manufacturer shall conduct repeated self-inspections as part of the quality assurance system in order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective measures. Records shall be maintained of such self-inspections and any corrective action subsequently taken.
第九章 自检
原则
应当进行自检,为了监控药品生产质量管理规范基本原则的实施及符合性,并提出必要的纠正措施。
9.1 应当按预定的程序,对人员情况、厂房与设施、设备、文件管理、生产管理、质量控制、药品销售、投诉和召回的处理以及自检进行定期检查,以证实符合质量保证原则。
9.2 应当由公司指定的具有资质的人员进行独立、详细的自检。也可以由外部专家进行独立的审计。
9.3 所有自检应当有记录。 自检报告中应当包括自检过程中观察到的所有情况,以及纠正措施建议,如果有的话。 也应当记录随后釆取的措施。
2. 质量管理
2.4 内部审计(自检)
2.40 为了检验和 APIs 的 GMP 规则的一致性,应根据已批准的计划进行定期的自检。
2.41 须对检查结果和纠正措施登记备案,并向企业管理层汇报,应及时有效地完成整改措施。
8.Self-inspection, quality audits and suppliers' audits and approval
8.1 Principle. The purpose of self-inspection is to evaluate the manufacturer’s compliance with GMP in all aspects of production and quality control. The self-inspection programme should be designed to detect any shortcomings in the implementation of GMP and to recommend the necessary corrective actions. Self-inspections should be performed routinely, and may be, in addition, performed on special occasions, e.g. in the case of product recalls or repeated rejections, or when an inspection by the health authorities is announced. The team responsible for self-inspection should consist of personnel who can evaluate the implementation of GMP objectively. All recommendations for corrective action should be implemented. The procedure for self-inspection should be documented, and there should be an effective follow-up programme.
Items for self-inspection
8.2 Written instructions for self-inspection should be established to provide a minimum and uniform standard of requirements. These may include questionnaires on GMP requirements covering at least the following items:
(a) personnel;
(b) premises including personnel facilities;
(c) maintenance of buildings and equipment;
(d) storage of starting materials and finished products;
(e) equipment;
(f) production and in-process controls;
(g) quality control;
(h) documentation;
(i) sanitation and hygiene;
(j) validation and revalidation programmes;
(k) calibration of instruments or measurement systems;
(l) recall procedures ;
(m) complaints management;
(n) labels control;
(o) results of previous self-inspections and any corrective steps taken.
Self-inspection team
8.3 Management should appoint a self-inspection team consisting of experts in their respective fields and familiar with GMP. The members of the team may be appointed from inside or outside the company.
Frequency of self-inspection
8.4 The frequency at which self-inspections are conducted may depend on company requirements but should preferably be at least once a year. The frequency should be stated in the procedure.
Self-inspection report
8.5 A report should be made at the completion of a self-inspection. The report should include:
(a) self-inspection results;
(b) evaluation and conclusions;
(c) recommended corrective actions.
Follow-up action
8.6 There should be an effective follow-up programme. The company management should evaluate both the self-inspection report and the corrective actions as necessary.

2.2 审计

第三章 机构与人员
第二十五条 质量受权人
(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。
Starting materials
5.29 For the approval and maintenance of suppliers of active substances and excipients, the following is required:
Active substances
Supply chain traceability should be established and the associated risks, from active substance starting materials to the finished medicinal product, should be formally assessed and periodically verified. Appropriate measures should be put in place to reduce risks to the quality of the active substance.
The supply chain and traceability records for each active substance (including active substance starting materials) should be available and be retained by the EEA based manufacturer or importer of the medicinal product.
Audits should be carried out at the manufacturers and distributors of active substances to confirm that they comply with the relevant good manufacturing practice and good distribution practice requirements. The holder of the manufacturing authorisation shall verify such compliance either by himself or through an entity acting on his behalf under a contract. For veterinary medicinal products, audits should be conducted based on risk.
Audits should be of an appropriate duration and scope to ensure that a full and clear assessment of GMP is made; consideration should be given to potential cross- contamination from other materials on site. The report should fully reflect what was done and seen on the audit with any deficiencies clearly identified. Any required corrective and preventive actions should be implemented.
Further audits should be undertaken at intervals defined by the quality risk management process to ensure the maintenance of standards and continued use of the approved supply chain.
Excipients
Excipients and excipient suppliers should be controlled appropriately based on the results of a formalised quality risk assessment in accordance with the European Commission ‘Guidelines on the formalised risk assessment for ascertaining the appropriate Good Manufacturing Practice for excipients of medicinal products for human use.
5.36 The rationale for the outsourcing of this testing should be justified and documented and the following requirements should be fulfilled:
ii. The medicinal product manufacturer should perform audits, either itself or via third parties, at appropriate intervals based on risk at the site(s) carrying out the testing (including sampling) of the starting materials in order to assure compliance with Good Manufacturing Practice and with the specifications and testing methods described in the marketing authorisation dossier;

2.2.3 EU GMP Chapter 7 Outsourced Activities

The Contract
7.17 The Contract should permit the Contract Giver to audit outsourced activities, performed by the Contract Acceptor or his mutually agreed subcontractors.

2.2.4 EU GMP Chapter 9 Self inspection

Principle
9.2 Self inspections should be conducted in an independent and detailed way by designated competent person(s) from the company. Independent audits by external experts may also be useful.
Quality audit
8.7 It may be useful to supplement self-inspections with a quality audit. A quality audit consists of an examination and assessment of all or part of a quality system with the specific purpose of improving it. A quality audit is usually conducted by outside or independent specialists or a team designated by the management for this purpose. Such audits may also be extended to suppliers and contractors (see section 7“Contract production and analysis”, ).
Suppliers' audits and approval
8.8 The person responsible for quality control should have responsibility together with other relevant departments for approving suppliers who can reliably supply starting and packaging materials that meet established specifications .
8.9 Before suppliers are approved and included in the approved supplier’s list or specifications , they should be evaluated. The evaluation should take into account a supplier’s history and the nature of the materials to be supplied. If an audit is required, it should determine the supplier’s ability to conform with GMP standards.

3. 资源推荐

3.1 资源专题

制药人成长——审计与自检
https://zhiku.bopuyun.com/zhuanti/81377079243

3.2 优质课程

制药人必看-原辅料供应商审计
https://zhiku.bopuyun.com/pc/college/177
QA应如何进行审计准备工作
https://zhiku.bopuyun.com/pc/college/lesson/1383
发布于 2022-08-02 12:09:19 © 著作权归作者所有