如何准备俄罗斯GMP检查

How to prepare for RussianInspections

如何准备俄罗斯检查

Although theidea and content of GMP guidance in different countries or regions is quitecomparable, there are no common global GMP regulations - and inspectors fromvarious national competent authorities come andinspect facilities in other countries.

虽然不同国家或地区的GMP指南大同小异，但没有通用的全球GMP法规,各国主管当局的检查员来检查其他国家的设施。

Inspectors fromRussia come on behalf of the so called Certification Center within the Ministryof Industry and Trade (MoIT). The MoIT will - after successful inspection -issue a GMP Certificate. This certificate has been required for new submissionssincec 2016 and for renewals/ variations since 2017. No products without aRussian GMP certificate can be exported to Russia. If a site does not pass theinspection, CAPAs should be completed and a new submission with supportingdocuments will be required.

俄罗斯的检查员来自工业和贸易部(MoIT)认证中心。在检查成功后,MoIT将颁发GMP证书。自2016年后新建的和 2017 年后续签/变更都需要此证书。没有俄罗斯GMP证书的产品不得出口到俄罗斯。如果一个工厂未通过检查,则应完成 CAPA后重新提交申请，并带有证明文件。

Request of anInspection

检查的要求

When requestingan inspection, different documents (forms) will be requested by the MoIT:

要求检查时,MoIT 会要求不同的文件(表格):

  • Form 1: contact details of local authority and company

    表格1：当地药监局和公司的联系方式

  • Form 2: list of recalls and complaints (2 years)

  • 表格2：召回和投诉清单(2年)

  • Form 3: list of medicinal products manufactured at the site

    表格3：工厂生产的医药产品清单

  • Form 4: Letter of Consent for conducting an inspection

    表格4：检查同意书

  • Site Master File (SMF)

    工厂主文件

  • Power of Attorney

    委托书

  • Manufacturing authorization

    生产许可

  • Extract from the commercial register

    商业注册摘录

All documentshave to be notarially certified!

所有文件都必须经过公证！

So what willthey look for when they come for an inspection?

那么，他们如何检查呢？

Russianinspectors seem to focus mainly on documentation review and site tours to watchthe manufacturing process:

俄罗斯检查员似乎主要侧重于文件审查和现场考察，以观察生产过程:

  • They spend a lot of time understanding area operations, layout,     temperature control in production including mapping in the warehouse.

    他们花费大量时间了解生产中的区域布置、布局、温度控制,包括仓库温度分布。

  • The focus is on understanding the processes, the equipment used and     how the areas are managed, including transfer of materials between graded     areas.

    重点是了解工艺、使用的设备以及级别管理,包括在不同级别之间的物料转移。

  • Also quality systems will be reviewed including Annual Product     Reviews and the respective changes communicated to MoIT versus changes     listed in the APR.

    此外,还将对质量体系进行审查,包括年度产品回顾以及向 MoIT 提交的相关变更与 APR 中列出的变更。

Wrap up

收尾

The final wrapup at the end of the inspection will be a verbal description of observationsincl. a classification (minor, major, critical). Within one week, observationsthat need additional clarification are sent to the company but no draft reportwill be issued for the site to comment in general. After 30 days, a finalreport is issued (the classification of the observations may have changed basedon information received). However it can take several weeks before MoITdetermines whether a GMP certificate is granted, based on the amount andseverity of observations made.

检查结束后以对观察（缺陷）项的口头描述作为收尾，包括分级(微小、主要、严重)。将在一周内发送给公司需要进一步说明的观察（缺陷）项，但一般不会向工厂发布报告草稿。30天后，将发布最终报告(根据收到的资料，缺陷的分类可能有所变化)。但是,MoIT 可能需要数周时间才能根据所观察到的缺陷的数量和严重性确定是否授予 GMP 证书。

公众号

GMP办公室

  • 专业的GMP合规性研究组织

  • 国内外（FDA、EMA、MHRA、CFDA、WHO、PIC/S等）GMP法规解读；

  • 国内外制药行业GMP监管动态；

  • GMP技术指南（ISPE、PDA、ISO、ASTM等）分享

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