201502 EMA: 关于GMP的问答(3)---Julia翻译

巴西木

EU GMP guide annexes: Supplementary requirements: Annex 16

EU GMP指南附录：补充要求：附录16

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1. Can a site have more than one QP performing certification of batches?

一个工厂可以有不止一个QP对批次进行认证吗？

EU legislation requires a manufacturer to have at least one QP at its disposal but a site may have more than one QP who may certify batches on behalf of the manufacturer.

EU药品法要求一个生产商至少需要有一个QP，一个工厂可以有不止一个QP代表生产商对批准进行认证放行。

2. Can there be more than one QP involved in the certification of a given batch?

可以有不止一个QP对指定批次进行认证吗？

Annex 16 of the EU GMP guideline gives guidance in relation to situations where different stages of manufacture of a batch take place at different manufacturing sites.

EU GMP指南附录16给出了关于在不同生产场所生产同一个批次的不同步骤时的情况的指南。

In such cases, the overall responsibility for correct manufacture of the batch lies with the QP performing final certification of the batch before release for sale. It is also possible that, at a single manufacturing site, different QPs could be responsible for certification of different stages of manufacture of the batch.  However, as before, the QP performing final certification before release holds overall responsibility for manufacture of the batch in accordance with GMP and the marketing authorisation.

在这种情况下，批次被正确生产的总体责任是由将该批最终放行销售的QP来承担的。也有可能在同一个生产场所，不同QP可以负责对同一批次不同生产步骤的放行。但是，和前面一样，实施最终放行的QP负有全面责任来保证该批次的生产符合GMP和上市许可。


EU GMP guide annexes: Supplementary requirements: Annex 19: Reference and retention samples 欧盟GMP指南附录：补充要求：附录19：对照品和留样

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1. Is it necessary to retain a sufficient number of samples of each batch of a sterile medicinal product in order to carry out a sterility test on two separate occasions? H+V October 2008

是否有必要保留足够数量的无菌药品样品以备2次单独的无菌测试用？H+V 2008年10月

For retention purposes, it is not necessary to keep the full number of samples required in table 2.6.1.3 of the European Pharmacopoeia sterility test monograph to repeat the sterility test performed for release purposes, but only a sufficient quantity to allow the carrying out, on two occasions, of a confirmatory test using the minimum quantities described in table 2.6.1.2 of the monograph.

为了留样的目的，保留EP无菌测试各论表2.6.1.3中所需样品量来重复放行目的无菌测试是没有必要的，只需要有足够的数据能够实施表2.6.1.2所述的最小数量符合性测试用的2倍量即可。


General GMP 一般GMP问题

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1. What are the differences between EU and World Health Organization (WHO) requirements for GMP? H July 2006

EU和WHO对GMP的要求有什么不一样？H 2006年7月

EU GMP principles and guidelines are laid down in Directive 2003/94/EC (human medicines) and Directive 91/412/EEC (veterinary products). These principles and guidelines are subject to further detailed guidance in the form of the EU GMP guideline with its annexes.

EU GMP原则和指南在指令2003/94/EC（人药）和指令 91/412/EEC（兽药）中给出。针对这些原则和指南还以EU GMP指南及附录的形式提供了详细的指南。

WHO publishes its own GMP guidance documents.

WHO公布了其自己的GMP指南文件。

Although EU and WHO GMP guidance documents do differ in some details, the main principles remain the same. EU requirements fulfil all the recommendations of WHO.

尽管EU和WHO GMP指南文件在细节上有区别，但主要的原则还是一样的。EU要求满足所有的WHO推荐要求。


GMP certificates /GMP证书

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1. What is a GMP certificate and what is the difference between GMP certificates, certificates of medicinal product (CMPs, also called certificates of pharmaceutical products, CPPs) and certificates of suitability to the monographs of the European Pharmacopoeia (CEPs)? H+V July 2006

什么是GMP证书？GMP证书、药品证书（CMP，也称为药品认证书CPP）和欧洲药典适用性证书（CEP）的区别是什么？H+V 2006年7月

A GMP certificate is a certificate issued following a GMP inspection, by the competent authority responsible for carrying out the inspection, to confirm the GMP compliance status of the inspected site.

GMP证书是在GMP检查之后，由负责检查的药监机构签发，确认被检查工厂的GMP符合性状态的证书。

GMP certificates are site-specific, but can be restricted to particular activities depending on the scope of the inspection (e.g., manufacturing activities related to a specific product). Directives 2001/82/EC and 2001/83/EC , as amended state that after every GMP inspection, and within 90 days of the inspection, a GMP certificate shall be issued to a manufacturer, if the outcome of the inspection shows that the manufacturer complies with GMP.

GMP证书是针对一个工厂的，也可以限制在一个特定的活动范围内，这取决于检查的范围（例如，与一个特定产品相关的生产活动）。指令2001/82/EC和2001/83/EC及其修订内容说明了在每次GMP检查之后，如果检查结果显示该生产商符合GMP要求，则在检查完90天内，要将GMP证书签发给生产商。

CMPs are product-specific certificates issued by the competent authority that granted the marketing authorisation. The European Medicines Agency issues CMPs on behalf of the European Commission for centrally authorised products.

CMP是针对产品的证书，它由颁发上 市许可的药监机构签发。欧洲药品管理局（EMA）代表欧盟委员会对集中审评药品签发CMP。

CMPs are issued in the context of the World Health Organization certification scheme on the quality of pharmaceutical products moving in international commerce, to confirm the marketing-authorisation status of the products. These certificates also confirm the GMP compliance status of the manufacturing sites. CMPs are mainly used by companies to support applications to export their pharmaceutical products to countries with less-developed regulatory systems.

GMP是根据WHO关于药品质量国际认可认证计划签发的，用以确认药品的上市许可状态。这些证书也确认生产场所的GMP符合性。CMP主要是公司用于支持其出口药品至欠发达法规体系国家的申报。

CEPs are certificates issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM) to confirm that a certain active substance is produced according to the requirements of the relevant monograph of the European Pharmacopoeia or of the monograph on transmission spongiform encephalopathies.

CEP是由EDQM颁发的证书，用以确认某种活性物质的生产符合相关的欧洲药典各论或TSE各论要求。

CEPs can be used by companies when submitting an application for marketing authorisation, and replace much of the documentation required for the active substance in the marketing-authorisation dossier. GMP inspections of active-substance manufacturers can be requested by EDQM in the context of the CEP certification scheme.

CEP可以由公司用于提交上市许可，替代在上市许可申报资料中所要求的活性物质部分文件。根据CEP认证计划，EDQM可以要求对活性物质生产商进行GMP检查。

2. Does the Agency issue GMP certificates? H+V July 2006

欧盟药品管理局是否签发GMP证书？H+V 2006年7月

No, the competent authority responsible for carrying out the inspection issues the GMP certificate, or makes an entry of non-compliance into the EudraGMP database.

不会。实施检查的药监机构负责签发GMP证书，或将不符合结果输入EUDRAGMP数据库。

3. Which EU and EEA authorities conduct mutually recognised inspections and issue GMP certificates? H+V November 2011

哪个EU和EEA药监机构进行互认检查，以及签发GMP证书？H+V 2011年11月

All EU and EEA national competent authorities conducting inspections are obliged to enter GMP certificates in the EudraGMP database. Hence, any GMP certificate appearing in the database is mutually recognised and the database authenticates the certificate.

所有实施检查的EU和EEA国家药监机构都有义务将GMP证书输入EUDRAGMP数据库。因此，任何出现在该数据库的GMP证书都是互认的，数据库会对证书进行鉴证。

If a certificate cannot be found in the database, the issuing authority should be contacted.

如果在数据库中找不到证书，则要联系签发证书的药监机构。


Inspection coordination 检查协调

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1. Does the Agency perform GMP inspections? H+V July 2006

欧盟药品局是否实施GMP检查？H+V 2006年7月

The Agency does not perform inspections. They are carried out on its behalf by the national competent authorities of the member states of the EEA, in connection with products under the centralised marketing-authorisation procedure.

欧盟药品局不实施检查。对于经由集中上市许可审评程序的产品，由EEA成员国药监机构代表欧盟药品局进行现场检查。

2. If a site in a third country has plans to export products to the EEA, is it possible to apply for a GMP inspection on a voluntary basis? H+V July 2006

如果第三国工厂计划出口药品至EEA，是否可以自愿申请进行GMP检查呢？H+V 2006年7月

Normally, the need for inspection under these circumstances is triggered by an application for a marketing authorisation. It may be possible to request an inspection on a voluntary basis, but as the competent authorities will have other priorities, there is no guarantee that such a request will be met.

一般来说，在这种情况下检查是由上市许可申报激活的。也可以自愿申请检查，但由于药监机构会有其他的优先考虑，无法保证一定能满足这样的申请。

To explore this possibility, the authorities of the Member State into which the product will be imported into the EEA should be approached. In any case, applicants are encouraged to approach the relevant authority in advance of submission in order to facilitate third-country inspection planning.

要知道是否可能进行检查，应与进口入EEA的成员国药监机构联系。不管怎么，鼓励申报人在申报提交前即与相关药监机构联系，以便计划对第三国工厂的检查。

3. When a new application is submitted in the EEA and a GMP inspection is deemed necessary, which competent authority carries out the inspection? H+V July 2006

如果在EEA提交了一份新的申报，且必须要进行GMP检查，哪个药监机构来实施这样的检查呢？H+V  2006年7月

If the site is located in the EEA, the competent authority of the Member State where the site is located carries out the inspection.

如果工厂是位于EEA的，由工厂所在成员国的药监机构将实施该检查。

For sites located in countries outside the EEA, the responsible authority for inspection (the 'supervisory authority') is the authority in whose territory the importing site is located. If the supervisory authority is not able to carry out the inspection for any reason, it can be delegated to another EEA competent authority.

如果工厂位于EEA以外国家，则入口国的药监机构要负责该项检查。如果药监机构由于任何理由不能实施检查，则可以委派另一个EEA有资质的药监机构实施检查。

If there is a mutual recognition agreement (MRA) in place between the countries where the site is located and the European Community, the results of GMP inspections carried out by the MRA partner authority are normally recognised by the EU authorities.

如果工厂所在国与欧共体有互认协议，则MRA伙伴国药监机构的检查结果通常会被欧盟药监机构所接受。

土豆王

感谢楼主分享！

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孙艳红

不错的问题汇总，新年快乐

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yanzhengren

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