欧洲与美国的GMP合规对比

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[color=rgba(0, 0, 0, 0.9)]BioPharm International

[color=rgba(0, 0, 0, 0.9)]BioPharm International May 2025

[color=rgba(0, 0, 0, 0.9)]Volume 38

[color=rgba(0, 0, 0, 0.9)]Issue 4

[color=rgba(0, 0, 0, 0.9)]Pages: 26

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

[color=rgba(0, 0, 0, 0.9)]“尽管存在全球协调一致的趋势，但美国和欧洲的GMP要求之间仍存在差异，制造商应当了解这些差异，” Parexel 技术副总裁 Siegfried Schmitt 博士说道。

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[color=rgba(0, 0, 0, 0.9)]Q: We understand that the European Union’s good manufacturing practice (GMP) regulations are quite similar to the US Code of Federal Regulations (CFR). Can you explain some key differences?

[color=rgba(0, 0, 0, 0.9)]问题：我们了解到，欧盟的良好生产规范（GMP）法规与美国联邦法规（CFR）非常相似。你能解释一些关键的不同点吗？

[color=rgba(0, 0, 0, 0.9)]A: You are correct that there are many similarities, not least because the United States and the EU have long worked towards global harmonization of GMP regulations. GMP regulations in one form or another have been around for half a century or more, so there has been plenty of time for alignment. The differences in the two regulatory systems are certainly twofold: the specific wording and requirements aren’t identical, and the two entities (US and EU) themselves are distinctly different.

[color=rgba(0, 0, 0, 0.9)]回答：你提到的相似性是正确的，这部分是因为美国和欧盟长期以来一直致力于推动GMP法规的全球协调统一。GMP法规以某种形式存在已有半个世纪以上，因此有足够的时间进行调整和统一。然而，两个监管体系之间的差异主要体现在两个方面：具体的措辞和要求并不完全相同，而且这两个实体（美国和欧盟）本身也有显著的区别。

[color=rgba(0, 0, 0, 0.9)]Whereas the US has one CFR that applies as is in all US States, the EU has a regulatory system that is based on Union law and the laws of the 27 Member States (MS). Thus, the EU regulations are only harmonized to some degree, particularly in their interpretation, resulting in many member-state specific requirements and procedures.

[color=rgba(0, 0, 0, 0.9)]在美国，有一部适用于所有州的单一CFR（《联邦法规汇编》），而欧盟则有一个基于联盟法律及其27个成员国法律的监管系统。因此，欧盟的法规只在一定程度上实现了协调统一，特别是在解读上，这导致了许多成员国特定的要求和程序。

[color=rgba(0, 0, 0, 0.9)]Differences between the two regulatory systems are also in their structures. US 21 CFR 211 describes GMP for finished pharmaceuticals in the US. To find the equivalent regulations in the EU, it is easiest to go to EudraLex–Volume 4–Good Manufacturing Practice (GMP) guidelines (1). The EU laws are directives, which need to be transposed into national law in the MS. Though EudraLex provides the consensus interpretation of the directives, each MS can and likely has interpreted some parts slightly differently.

[color=rgba(0, 0, 0, 0.9)]美国的21 CFR 211描述了美国成品药的GMP要求。要找到欧盟中的等效规定，最简单的方法是查阅EudraLex（《欧盟药事法规集》）——第4卷——GMP指南 (1)。欧盟的法律是指令，需要转化为各成员国的国家法律。尽管EudraLex提供了对这些指令的共识解读，但每个成员国可能会对某些部分有不同的解读。

[color=rgba(0, 0, 0, 0.9)]A distinct difference exists with regards to drug product release (to the market). In the US, this is under the authority of the quality control unit (21 CFR 211.22), whereas in the EU this can only be performed by a Qualified Person (QP) (2). The QP can be a member of the quality unit, or even be an independent consultant, depending on the applicable national or regional legal requirements. For certain products (e.g., blood products), an additional release by the Official Control Authority Batch Release is required (3). And should you be confused about the quality unit terminology, please see the article, “The Role of the Quality Unit” (4).

[color=rgba(0, 0, 0, 0.9)]关于药品上市许可放行，美国是由质量控制部门负责（21 CFR 211.22）。而在欧盟，这一职责只能由“受权人”（Qualified Person, QP）(2) 执行。QP可以是质量部门的一员，也可以是独立顾问，具体取决于适用的国家或地区法律要求。对于某些产品（如血液制品），还额外需要官方控制机构批次放行（Official Control Authority Batch Release）(3)。如果你对质量部门的术语感到困惑，请参阅文章《质量部门的角色》(4)。

[color=rgba(0, 0, 0, 0.9)]A large number of products are aseptically manufactured. The sterilizing filter is thus a critical component in sterility assurance of the finished product. In the EU, Annex 1 (5) all but mandates that the integrity of the sterilised filter assembly should be verified by integrity testing before use (pre-use post sterilization integrity test or PUPSIT). There is no equivalent requirement in the CFR or FDA guidance documents. PUPSIT is yet another example of differing requirements or expectations.

[color=rgba(0, 0, 0, 0.9)]大量产品是通过无菌工艺生产的。因此，除菌过滤器在确保成品无菌方面是一个关键组件。在欧盟，《附录1》（5）几乎强制要求在使用前验证灭菌后的过滤器装置完整性（即“使用前-灭菌后完整性测试”或 PUPSIT）。而在美国《联邦法规》（CFR）或FDA指南文件中，并没有等效的要求。PUPSIT 就是欧美监管要求或期望存在差异的又一个例子。

[color=rgba(0, 0, 0, 0.9)]Tables that compare the EU and US regulations have been created by many a company. These are very useful; however, as shown above, this is not enough to really fully understand the detailed expectations, which are often published in guidances and in the case of the EU may only be available in national or regional communications in the local languages. For a full picture, it is always recommended to consult with the local agencies.

[color=rgba(0, 0, 0, 0.9)]许多公司都制作过对比欧盟和美国法规的表格，这些表格非常有用；然而，如上所述，仅靠这些表格还不足以真正全面理解那些详细的监管期望。这些期望通常发布在各类指导文件中，而在欧盟，有时只会在成员国或地区的本地语言通讯中体现。为了全面了解法规要求，始终建议与当地监管机构进行咨询沟通。

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References

• EC. EudraLex–Volume 4–Good Manufacturing Practice (GMP) Guidelines. https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
• EC. Annex 16–Certification by a Qualified Person and Batch Release. EudraLex–Volume 4, https://health.ec.europa.eu/document/download/20c41532-33d5-4635-ae80-8735d3d09fe0_en?filename=v4_an16_201510_en.pdf
• EDQM. Human Biologicals (OCABR). EDQM.eu. https://www.edqm.eu/en/omcl/human-biologicals-ocabr-
• S. Schmitt. The Role of the Quality Unit. Pharm.Technol. 2017 41 (9).
• EC. Annex 1–Manufacture of Sterile Medicinal Products. EudraLex–Volume 4https://health.ec.europa.eu/document/download/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf
  

About the author

[color=rgba(0, 0, 0, 0.9)]Siegfried Schmitt, PhD is vice president, Technical at Parexel.

Article details

[color=rgba(0, 0, 0, 0.9)]BioPharm International®
Vol. 38, No. 4
May 2025
Page: 26

Citation

[color=rgba(0, 0, 0, 0.9)]When referring to this article, please cite it as Schmitt, S. Complying with European versus US GMPs. BioPharm International 2025 38 (4)

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