由认证机构进行的GDP认证以及QP进行的GDP审计---危险的误解

20151014 ECA新闻：由认证机构进行的GDP认证以及QP进行的GDP审计---危险的误解  
GDP certification by accredited bodies and GDP audit by QPs - dangerous misunderstandings
由认证机构进行的GDP认证以及QP进行的GDP审计---危险的误解
With the publication of the new GDP Guideline in the year 2013 the legal requirements concerning the Good Distribution Practice have increased significantly. This has manifold consequences because now compliance with the quality requirements is controlled throughout the complete distribution chain until the final release to the patient. This is the objective at least.
随着新的GDP指南在2013年公布，对优良销售规范的要求已大大提高。这些要求产生了很多后果，因为现在质量要求的符合性已在整个销售链要求受控，一直延伸到最终放行给患者。这是最低的要求。
The competent supervisory authorities carry out GDP inspections of companies that undertake tasks requiring GDP in the course of distribution. And this is where the problem already starts. Since the date of availability of the new GDP Guideline each company which comes into contact with the supply chain of medicinal products tries to receive a GDP certificate. After all, it is the declared objective of the EU to guarantee GDP compliance throughout the complete supply chain. The GDP certificates are listed throughout Europe in a central database called EudraGMDP. Here, the GDP non-compliance reports are also recorded. So what could be more natural than to attempt to be listed there in order to demonstrate GMP compliance to the customers?
国家监管当局要对承担了销售业务，需要GDP管理的公司进行GDP检查。这里已经发现了问题。自从新的GDP指南发布，每个与药品供应链有业务的公司都想要获得一份GDP证书。最后，EU宣布其目标是在一个整个供应链中保证GDP符合性。整个欧洲的GDP证书已经在EUDRAGMDP数据库里列出。GDP不符合性报告也记录在这里。所以说，还有什么比列在这里更能向客户证明自己的GDP符合性呢？
But the EU GDP Guide defines the group of companies which are subject to supervision very strict. This means that many of the actors in the supply chain are not under supervision but must implement GDP nevertheless. The competent authority for GDP will normally not carry out GDP inspections at transport companies (shipping companies) or at airport hubs.
但是，EU GDP对进行监管的公司对象定义非常严格。这就是说，许多供应链里的活动者并不在监管范围内，但必须实施GDP。GDP监管当局一般不会对运输公司（海运公司）或机场进行GDP检查。
This gap is now filled by a number of service providers that grant GDP certificates. Some accredited or non accredited bodies have started to offer GDP certificates for shipping companies or even airports. An auditor of the (accredited) body carries out an audit and at the end a GDP certificate beckons which will then be advertised in the internet and in company brochures. And here a big misunderstanding arises. Because these commercial certificates cannot be compared to the GDP certificates issued by the supervisory authority. But many actors in the supply chain are not aware of this fact. The GDP certificate might be a marketing instrument such as the ISO 9001 certificate or a certificate certifying compliance with environmental standards. But it does not confirm GDP compliance within the meaning of an official GDP certificate. This can only be done by the competent supervisory authority.
这个差距现在由颁发GDP证书的大量服务商所弥补。一些经过认证或未经认证的公司已开始向货运公司甚至机场提供GDP证书。认证机构的一个审计员实施审计，最后会有一份GDP证书，这份证书会被放在网络上和公司的宣传小册中。这里就产生了很大的误解。因为这些商业证书并不能与监管当局所颁发的GDP证书相提并论。但供应链里的许多活动者并不明白这个情况。GDP证书可以是一种销售工具，例如ISO9001证书，或者符合环境标准的认证证书。但它并没有在官方的GDP证书意义上确认其GDP符合性。官方的GDP符合性证书只能由监管当局来签发。
One also hears more and more about so-called QP audits carried out by independent consultants who allegedly confirm GDP compliance by means of a GDP Certificate. As QPs play a central role in the pharmaceutical law it is assumed by some companies that these "QP certificates" have a particularly high significance and that they could virtually serve as substitute for the GDP certificate of the supervisory authority. But this is not the case - as has already been explained for the GDP certificates issued by accredited companies. A QP who actually works as part of the supplier qualification for a pharmaceutical company will never issue a GDP certificate or written confirmation.
大家现在越来越多听到所谓的QP审计，这些审计由独立的顾问实施，据说他们通过一份GDP证书确认了GDP符合性。由于QP在药事法里扮演了核心角色，因此有些公司以为这些“QP证书”具有特别重要的意义，以为这些证书可以真的取代监管当局的GDP证书。但其实并不是这样---正如已经解释的，这些GDP证书只是由一些经过认证的公司所颁发的。一个为制药公司工作的QP，在对供应商进行确认工作时，从来不会签发任何GDP证书或书面证明。
What should companies do that would like to have a GDP certificate but will not be inspected by the authority? It is important that each of these companies implements GDP. The requirements can be checked in the GDP Guideline. A further certificate is not required. The key is an internal quality management system for establishing GDP requirements with sufficiently qualified personnel. In the case of a new customer/supplier relationship, for instance, the external auditor will want to see the concrete implementation of GDP - regardless of a GDP certificate of any organisation.
那么公司要怎么样做才能获得一份GDP证书，但却不要监管当局来检查呢？对这些公司来说很重要的是实施GDP。GDP的要求可以在GDP指南中找到。证书其实是不一定需要的。关键是由足够资质的人员来建立内部质量管理体系，符合GDP要求。例如，对于新的客户/供应商关系，外部审计人员就要看看具体的GDP实施情况---而不管是否有任何组织签发GDP证书。

来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720159170744508/

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