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EMA发布无菌药GMP检查国际合作

EMA及其国欧洲和国际合作伙伴现发起试点项目,以强化其在人用无菌药品生产商现场检查方面的合作。
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来自:Julia法规翻译
EMA及其国欧洲和国际合作伙伴现发起试点项目,以强化其在人用无菌药品生产商现场检查方面的合作。该新项目是基于从类似合作项目(国际API现场检查项目)中所获得的成功和经验启动的。
在合作项目中,EMA、EU国家药监局(法国和英国)、美国FDA、澳大利亚(TGA)、加拿大卫生局、日本PMDA和WHO将共享对参与国以外的无菌生产商的现场GMP检查信息
国际检查合作已被证明通过参与各方药监当局的相互依赖,有利于改进对生产商的监管,最大限度利用全球检查资源,减少重复检查,增加全球被检查场所的覆盖率。项目参与方职责范围文件中列出了该新合作的目标、范围和原则。
该项目的产品范围为化学来源和特定治疗用生物技术衍生产品的人用无菌药品(例如,单克隆抗体和重组蛋白)。不在该项目范围内的产品为疫苗、细胞和基因治疗产品以及血浆制品。
试点项目将持续至少2年,之后参与各方将对项目进行评估,决定下一步合作措施。
以下是原文
译文仅供参考,英文原文参见EMA官网,中英文下载
链接:https://pan.baidu.com/s/1p659dcF39r9LMeV8IgEfKQhttps://pan.baidu.com/s/1p659dcF39r9LMeV8IgEfKQ
提取码:gzix
Pilot programme for international cooperation in GMP inspection of manufacturers of sterile medicinal products for human use
无菌人药生产商GMP检查国际合作试点项目
Terms of reference for participating authorities
参与药监局职权说明
Introduction 概述
The benefits of international collaboration in the inspection of manufacturers of active pharmaceutical ingredients have been demonstrated over a number of years . More efficient use of international inspectional resources facilitates broader inspectional coverage and allows risk-based inspection planning, there by benefitting public health and patients by focusing on sites of highest identified risk.
API生产商现场检查国际合作的益处已在过去数年得到了证明。更为有效地利用国际检查资源有利于提高检查覆盖率,使得基于风险规划检查成为可能,从而通过聚焦于所识别出的最高风险场所而对公众健康和患者带来益处。
The purpose of this document is to set out the terms of reference, including objectives, scope, requirements and general principles of an international inspection pilot programme covering manufacturers of sterile medicinal products. The purpose of the programme is to foster mutual cooperation and confidence between participating regulators through better communication and exchange of information on inspection planning.
本文件的目的是设定无菌药品生产商国际检查试点项目的权责内容,包括目的、范围、要求和通则。项目目的是通过在检查规划方面的良好沟通和信息互换培养合作药监机构间的相互合作和互信。
The regulatory authorities (hereafter referred to as ‘participating authorities’) taking part in this programme do so voluntarily. All participating authorities must be obliged by law to have systems in place to verify the Good Manufacturing Practice (GMP) status of medicinal product manufacturers whose products are marketed in their territory and imported from third countries. These regulatory authorities ensure that manufacturers located in their territory and in third countries are subject to routine GMP inspections to verify the GMP status. In committing to participate in the pilot each participating authority agrees to:
参与本项目的药监当局(以下称为“参与药监局”)均为自愿。所有参与药监局必须履行其法律义务,具备检查在其领土内上市销售药品和从第三国进口药品的药品生产商GMP状态的检查系统。这些药监局应确保其境内生产商和第三国生产商接受常规GMP检查,以核查其GMP状态。参与试点项目的药监局均一致同意:
•coordinate inspection planning through risk-based approaches and share, in advance, their prospective inspection plans for the two years of the pilot with participating authorities;
•通过基于风险的方法协作规划检查,并且在2年试点期间提前与其它参与药监局分享其预期检查计划;
•conduct inspections in the manner described herein;
•以本文件中所述方式执行检查;
•share information in English on inspection outcomes on amonthly basis;
•每月以英语分享检查结果;
•provide inspection reports to other participants if requested.
•其它参与药监局申请时,将检查报告提供给申请方。
Definitions定义
The below definitions are applicable in the context of this presentdocument and are intended to ensure clarity among participating authorities.
以下定义适用于本文件,旨在确保参与药监局之间透明度。
•Concurrent inspection: two or more sole routine inspections performed independently but at the same time by two or more participating authorities. Generally, each inspection has a different scope but this can change on a case by case basis.
•同步检查:同时由2个或更多参与药监局执行的2个或更多单一独立常规检查。一般来说,每个检查均有不同范围,但各案可能有变化。
•Duplicate inspection: a routine inspection performed at the same time or within a very short timeframe (e.g. within 6 months) by two or more participating authorities in a completely independent manner focusing on the same scope, process or product.
•重复检查:由2个或更多参与药监局在完全独立情况下在非常短时间内或同时执行的常规检查(例如,6个月内),关注相同范围、工艺或产品。
•Joint inspection: a routine inspection planned, coordinated and conducted together by two or more participating authorities.
•联合检查:由2个或更多参与药监局一起规划、协作和执行的常规检查。
•KPI: key performance indicator is used to measure of pilot success.
•关键绩效指标:用于测量试点成功与否的关键绩效指标。
•Master list: the consolidated list of sites of common interest provided and agreed to by each participating authority at the start of the pilot programme. The minimum set of information to be included regarding each site is set forth in Appendix III.
•主清单:试点项目启动时,由各参与药监局提供并同意的共同感兴趣的场所的综合清单。附录III中列出了每个工厂所需包括的最少信息。
•Participating authority:regulatory authority taking part in the pilot phase of the international GMP sterile medicinal products inspection programme.
•参与药监局:参与GMP无菌药品国际检查项目试点阶段的药监当局。
•Site of common interest: manufacturing site scheduled for inspection by at least two participating authorities.
•共同感兴趣的场所:有至少2个参与药监计划进行检查的生产场所。
•Sole inspection: a routine inspection planned, coordinated and conducted by one participating authority.
•单独检查:由1个参与药监计划、协作和执行的常规检查。
•Third country: a countrywhich is not in the territory of supervision of any of the participating authority. EEA Member States are not considered third country.
•第三国:不在任何参与药监的监管领土内的国家。EEA成员国不认为是第三国。
Objectives目的
The objective of the pilot phase is to confirm the terms of reference and to foster international collaboration, and information sharing in GMP inspection planning.
试点阶段的目的是确认权责条款,培养GMP检查计划国际协作和信息共享。
Scope范围
•This agreement applies to national and international regulatory authorities and to regulatory components of international organisations that are responsible for the coordination and conduct of GMP inspections of manufacturers of sterile medicinal finished products for human use located in third countries. Participating authorities are listed in Appendix I.
•本协议适用于国家和国际药监局和负责协作和执行第三国无菌人药生产商GMP检查的国际组织中的法规部门。参与药监列在附录I中。
•Products in scope are marketed sterile pharmaceutical medicinal products for human use of chemical origin and certain marketed therapeutic biotechnology-derived biological products (such as monoclonal antibodies and recombinant proteins). Products currently out of scope of this pilot are vaccines, cell and gene therapies andplasma derived pharmaceuticals.
•产品范围为已上市化学来源无菌人用药品和特定已上市治疗用生物技术衍生药品(例如单克隆抗体和重组蛋白)。不在本试点范围内的产品有疫苗、细胞和基因治疗产品和血浆制品。
•The pilot will cover routine surveillance inspections of previously GMP compliant sites. For-cause or pre-approval inspections can be included at the discretion of participants.
•试点将覆盖之前GMP合规场所的常规监管检查。参与方可自由决定是否包括有因检查和批准前检查。
•The pilot will include only third country manufacturing sites of interest to at least two participating authorities (site of common interest) and reported in the Master List.
•试点将只包括至少有2个参与药监局感兴趣并报告进入主清单的第三国生产场所。
•Reliance on participating authorities’ inspections should be preferred over sole inspections so that sole inspections are deferred or postponed based on another participating authorities’ inspection.
•参与药监方应优先依赖其它方的检查,而不是独立检查,根据另一参与药监的检查结果取消或推迟单独检查。
•Joint inspections should be preferred over sole and concurrent inspections.
•联合检查应优先于单独检查和同步检查。
•For sole or concurrent inspections every effort should be made to equally distribute the work across all participating regulatory authorities. Inspectorates should agree to separate on-site inspection plans in advance to avoid unnecessary duplication. For sole or concurrent inspections, it is expected that resources will be allocated independently by the participating authorities and that separate reports will be drafted at the end of the inspection(s).
•在单独检查或同步检查中,应尽量在参与药监局之间平均分配工作。检查员应同意提前拆分现场检查计划,以避免不必要的重复工作。在单独检查或同步检查中,要求参与药监局独立配置资源,检查结束时分头起草报告。(译者注:此段第一句可能有误,应为联合检查中需要平均分配工作)
•Duplicate routine inspections should preferably be avoided.
•应尽量避免重复常规检查。
发布于 2020-05-22 18:02:11 © 著作权归作者所有
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