FDA公布组合医用产品的cGMP要求指南

20150128 ECA新闻：FDA公布组合医用产品的cGMP要求指南  

2015-02-03 23:20:30|  分类： ECA新闻|

GMP News

28/01/2015

FDA publishes Guidance on cGMP Requirements for Combination Products

FDA公布组合医用产品的cGMP要求指南

In ourGMP News from 10 April 2013, we reported about FDA's new GMP regulations for Combination Products (combination of a medical device with another product, e.g.  a drug). These regulations came into force on 22 July 2013 as 21 CFR 4. The scope of these GMP provisions is relatively "light" and has been drafted in a kind of Question & Answer form. Now, the FDA has released the draft of Guidance on GMP requirements for Combination Products.  

在我们2013年4月10日的GMP新闻中，我们报道了FDA关于组合医用产品（由医疗器械与另一种产品，例如，一种药品组合）的新GMP法规。这些法规在2013年7月22日作为21CFR4已经生效。这些GMP条款的范围是相对“较小”的，且已以一种问答的方式进行了起草。现在FDA将复合医用产品的GMP要求指南草案公布征求意见。

The document - composed of 46 pages ist pretty extensive. It is divided into 6 chapters:

该文件有46页，内容非常多，共分为6章：

I Introduction
II Background
III General Considerations for CGMP Compliance
IV What do I need to know about the CGMP requirements specified in 21 CFR 4.4(b)?
V Application of CGMP requirements to specific types of combination products
VI Contact Us
VII References

第一章 绪论

第二章 背景

第三章 CGMP符合性基本要求

第四章 我需要知道21CFR 4.4(b)中的哪些CGMP要求？

第五章 CGMP要求在特定类型的组合医用产品中的应用

第六章 联系方式

第七章 参考文献

The introduction briefly outlines the content of the document. The definition of Combination Product is given in the background (Chapter 2) which provides an overview of 21 CFR 4. In Chapter III the draft deepens definitions like the term "manufacturer" and gives general explanations about which GMP requirements apply to a product or a manufacturing facility. Comparable to 21 CFR 4, the explanations are also presented in a Question & Answer system. An individual subchapter addresses the topic Change Control to a combination product (not in the Question & Answer system in this case).

绪论部分简要列出了文件的内容。组合医用产品的定义在背景（第二章）中给出，其中对21CFR4进行了简要回顾。在第三章中，给出了一些定义如“生产商”的更深入的定义，给出了关于哪些GMP要求适用于一个产品或一个生产设施的原则性解释。与21CFR4相比，这些解释也在一份问答系统中出现。有一个单独的子章节说明关于对组合医用产品（这种情形没在问答系统内）的变更控制问题。

The content of Chapter IV concretely goes into the specifications of medical devices (from a drug manufacturer perspective). For example the responsibilities of the management (21 CFR 820.20) or the topic Design (21 CFR 820.30) are addressed - i.e. provisions which aren't regulated as medical devices in the drug environment. Conversely - from a medical device manufacturer perspective - provisions specific to drugs (e.g. on stability testing, 21 CFR 211.166 and reserve samples, 21 CFR 211.170) are explained in detail. In addition, the draft specifies Compliance requirements when the medical device is combined with a biological product (21 CFR 600-680) or tissue (21 CFR 1271).

第四章的内容给出了医疗器械的具体标准（从药品生产商的角度）。例如，其中说明了管理责任（21CFR820.20）或设计主题（21CFR820.30）---即在药品环境中未规定的医疗器械条款。相反--从医疗器械生产商的角度—对药品的特定条款（例如，关于稳定性试验，21CFR211.166和留样，21CFR211.170）进行了详细解释。另外，草案中指出了当医疗器械与生物制品组合（21CFR600-680）或与组织组合（21CFR1271）时的符合性要求。

Chapter V is of utmost interest: it describes detailed regulations e.g. also a risk analysis as part of the design process. However, these detailed regulations refer to only three product groups:
1. Prefilled syringes,
2. Drug-coated meshes and
3. drug-eluting stents.

第五章是最有用的，它描述了详细的规范要求，例如，风险分析作为设计过程的一部分。但是，这些详细的法规仅包括了三种产品类型：

1. 预充式注射剂

2. 药膜筛以及

3. 药物释放支架

The document ends with the contact data of the respective Offices (CDER, CBER, CDRH and Office of Combination Products) and a list of references to relevant FDA documents for medical devices, drugs, biological products, tissues and combination products.

文件结尾是各相关办公室的（CDER、CBER、CDRH和组合医用产品办公室）联系数据，以及对相关医疗器械、药品、生物制品、组织和组合医用产品的FDA文件的引用清单。

Conclusion: although it is only a draft, Chapter 4 with its detailed regulations i.e. cGMP requirements reveals to be interesting. Yet, they only address explicitly prefilled syringes, drug-coated meshes and drug-eluting stents.

总结：尽管它只是一份草案，第四章中详细的法规条款，即CGMP要求，仍很引人注意。当然，它们只适用于三类产品：预充式注射剂、药膜筛以及药物释放支架。

The draft guidance entitled "Current Good Manufacturing Practice Requirements for Combination Products" can be commented on within 60 days.

该题为“复合医用产品的CGMP要求”的指南草案在60天内征求意见。

Are you interested in (GMP) requirements on combination products both from a US-American and a European perspective? On 24 - 25 March 2015, anECA Combination Products course will take place in Vienna, Austria.

你对美国和欧洲关于复合医用产品的GMP要求感兴趣么？ECA将于2015年3月24-25日在奥地利维也纳举办复合医用品的讲座。

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201513112030735/

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