附录16 QP声明：重要问答

Annex 16 QP Certification: important Questions and Answers

附录16 QP声明：重要问答

What can a Supply Chain Diagram look like? How to rely on vendor-supplied samples? These are just two examples of questions being frequently asked in connection with the new Annex 16 of the EU-GMP Guidelines (Certification by a Qualified Person and Batch Release).

供应链结构图看起来会是什么样子？怎么才能依赖中间商提供的样品？这只是与EU GMP指南新附录16（QP声明和批放行）相关的常见问题中的两个例子而已。

The new Annex came into force in April 2016 with quite a few new requirements and expectations. And it is still causing some uncertainty. Some of the major questions have now been answered in a blog of the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate.

新附录自2016年4月起开始生效，其中有一些要求和期望，但其仍然引起了一些不确定的问题。有一些主要问题在MHRA的官方博客上给出了回答。

For example, the new Annex 16 makes clear that "samples may either be taken after arrival in the EU, or be taken at the manufacturing site in the third country in accordance with a technically justified approach which is documented within the company's quality system." But how should this Pharmaceutical Quality System be used to support reliance on the vendor-supplied samples? This question is the first one to be answered in the blog:

例如，新的附录16指明了“样品可以在到达EU之后采取，也可以根据公司的质量体系文件中所载的经过技术论证的方法在第三国的生产场所取样。”。如何使用PQS来支持供应商提供样品的可靠性呢？该问题是博客所回答的第一个问题。

"This could be similar to a typical vendor assurance programme for the qualification of a new vendor. For example, comparative analysis of samples taken in the third country and further samples taken after importation should be tested together, until a justification can be supported to rely on third country samples only. There should be assurances (through audit and technical agreement) that the manufacturing site takes the samples according to approved procedures, and that the samples are random and representative of the entire batch" (…), MHRA says.

“取样问题与常规的确认一个新的供应商的供应商保证计划类似。例如，将在第三国所取的样品与进口后所取的样品同时进行对比检测分析，得到的结果可以支持对第三国样品的依赖。这里，需要确保（通过审计和技术协议）在生产场所进行的取样操作是依据所批准的程序，样品是随机的，可以代表整个批次”（……）。MHRA如是说。

Answers to other questions discuss the timing of comprehensive scientific studies, comparative analysis and how "a review of any unexpected result or confirmed out of specification result could be performed".

对其它问题的回答讨论了全面科学研究的时间问题、对比分析以及如何“审核预期外结果或确认的OOS结果”。

Annex 16 also requires the mapping of the supply chain: "The entire supply chain of the active substance and medicinal product up to the stage of certification is documented and available for the QP. (…) The document should preferably be in the format of a comprehensive diagram" (1.7.2). Now, with this blog, an example of such a supply chain diagram is provided to support the understanding of the supply chain and to "avoid any misinterpretation that can be caused by bulky documentation".

附录16还要求要画出供应链，“整个活性物质和药品的供应链直到认证阶段，都需要有文件记录，并且QP可以获取。（……）。文件最好是采用综合图表格式”（1.7.2）。现在，在该博客中，给出了一个此供应链图的例子，用以帮助理解供应链，以“避免可能会引起连篇累牍文件的错误诠释”。

The complete set of frequently asked questions can be found in part 1 of the MHRA blog.

完整的一套常见问题回答可以参见MHRA博客第一部分。