Enlisting Management Support for GMPs

罗伊鲱

Dear Clinic:
I currently work for a small medical device manufacturer with a big problem. Their first product was recently approved; now they want GMP to satisfy the FDA. That is where I come in.

When I was hired, I was told they had a good start toward compliance. Unfortunately, I did not confirm this with an audit prior to coming on board. Although they had previously brought in a consultant to start the process, I discovered that this company does not know the difference between a generic "boiler-plate" document and a specific operating procedure. The entire manufacturing process must be written for the company. Moreover, management is more concerned with marketing than with production, and consistently pulls personnel off GMP projects for marketing projects. Although they "walk the walk" of quality, implementing the structure is like pulling teeth. I have tried meeting with the various departments to explain concepts and priorities, but little gets done. They all feel they must control the process even though they do not understand the goal.

Prior to joining this firm, I worked with several companies to successfully implement GMPs. How can I deal with such stubborn resistance to a structured quality system?

Signed, Tug-of-War (and I'm the Rope!)

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Dear "Rope":
We certainly can appreciate your current situation. It often seems that the two groups who raise the most opposition to a structured quality system are R&D and Marketing, although for different reasons. When this happens, it is almost impossible to implement the GMPs successfully without the support of upper management. As you probably can attest to, no matter how much progress you make, chances are the structure ultimately is going to break down if you do not have the blessing of the "higher ups".

In a case like yours, we have a suggestion for dealing with the situation, with about a 50/50 chance of success. You may consider scheduling a short, focused, dynamic GMP training session for corporate management, emphasizing their responsibilities and regulatory liabilities on both the corporate AND personal levels, and the repercussions on non-compliance to the company's bottom line.

First, you should fully discuss the legal and regulatory power of the FDA, the Agency's ability to impose sanctions, and what those sanctions can include. Make sure Management understands the enormous extent to which they are personally liable for their company's lack of compliance. Many CEOs have no idea that they can be held accountable for their company's state of compliance. You might also want to emphasize the fact that FDA 483s are public information; i.e., make the point that potential damages are not restricted to the sanctions themselves, but can extend to a damaged reputation in the industry and marketplace. Plainly put, if your company has problems, your customers sooner or later will know about them. Restoring severely-damaged client confidence can take longer and be more expensive than correcting the compliance problems (and can cost more than implementing the GMPs to start with)!

Support your points by pulling in real-life stories from industry. Do a little research to find examples of companies who manufacture similar products and were non-compliant. Describe the regulatory actions that were taken with them, and their effects on each company. For starters, you should look at the Barr decision for an excellent recent example of the impact of regulatory sanctions.

Next, after you have scared the heck out of them with the facts about regulatory liability, focus their attention on the company's bottom line. First, make sure they understand that successful implementation of GMPs will maximize quality, while minimizing production cycle time, "on hold" time, required manpower, etc. Then, point out this eye-opener: for a product that could generate $300 million of sales in the marketplace in one year (not an unrealistic expectation), your company will LOSE $1 MILLION PER DAY for every day that product is delayed or otherwise prevented from reaching the marketplace.

Hope you didn't mind this long-winded response. As you can probably tell, we have conducted this kind of "fire and brimstone" training on a number of occasions. Needless to say, it's based on the theory that if you can't instill a quality mentality, you'll have to resort to fear! As previously mentioned, the success rate in our experience is about 50%, but if your company has potential, it's worth a try. Good luck and keep us posted.

叮儿

{:soso_e113:}{:soso_e112:}

GmpForEver

Who is Clinic? may be a GMP consultor.

胜利者

毒手药王邓智先

亲爱的诊所：

我现在有一个大问题的小的医疗设备制造商的工作。他们的第一个产品是最近批准了；现在他们要满足FDA的GMP。这就是我来的。

当我被录用，我告诉他们有一个良好的开端，对合规。不幸的是，我并没有证实这一审计到船上之前。虽然他们曾带来了一个顾问来启动的过程中，我发现这家公司不知道一个通用的“锅炉板”文件和具体操作程序的区别。整个生产过程必须为公司写的。此外，管理更关注的是销售比生产，不断把人员去营销项目的GMP项目。虽然他们的“走自己的路”的质量方针，实施结构就像是拔牙。我曾会见各部门解释概念和优先权，但没有完成的。他们都觉得他们必须控制的过程，即使他们不明白的目标。

在加入本公司之前，我与几家公司成功实施GMP工作。我怎么处理这些顽固的抵抗一个结构化的质量体系？

签署，拔河比赛（我的绳子！）

亲爱的“绳”：

我们一定会欣赏你的现状。似乎这两组人提高到一个结构化的质量体系是最反对的研发和营销，虽然出于不同的原因。当这一切发生的时候，它的实施与成功没有高层管理人员的支持几乎是不可能的。你或许可以证明，无论你多么努力，机会是结构最终将崩溃如果你没有“更高层的祝福”。

像你的情况下，我们处理的情况，建议，大约有50 / 50的成功机会。你可以考虑调度短，集中，企业管理的动态GMP培训会议，强调他们的责任和监管责任的企业和个人的水平，和不遵守的影响到公司的底线。

首先，你应该充分讨论的FDA的法律和监管的权力，该机构的能力进行制裁，这些制裁包括什么。确保管理层了解巨大的程度，他们的公司没有遵守个人责任。很多首席执行官都不知道他们可以在遵守公司的国家责任。你可能还想强调一个事实，FDA 483s是公共信息；即，使潜在的破坏是不受限制的制裁，但可以扩展到一个受损的声誉在行业和市场。坦率地说，如果你的公司有问题，你的顾客迟早会知道。恢复受损严重的客户的信心可能需要更长的时间，比修正的依从性问题（和更昂贵的成本超过实施GMP的开始）！

拉在现实生活中的故事业支持你的观点。做一点研究发现公司也生产类似产品实例进行非标准。描述了他们的监管措施，并在每个公司的影响。首先，你应该看看为监管制裁的影响一个优秀的例子，巴尔的决定。

接下来，在你吓死他们监管责任的事实，他们的注意力集中在公司的底线。第一，确保他们理解GMP的成功实施将最大限度地提高质量，同时最大限度地减少生产周期时间，“搁置”的时间，所需的人力，等。然后，指出这个大开眼界：对一个产品，一年就可产生在市场上销售的300000000美元（不是一个不切实际的期望），你的公司将失去1000000美元每天的每天，产品延迟或阻止到达市场。

希望你不介意这长篇大论的响应。你可以说，我们已经进行了这种“火与硫磺”在许多场合训练。不用说，它的基础上，如果你不能灌输质量心理理论，你将不得不诉诸恐惧！正如前面提到的，在我们经历的成功率约为50%，但如果你的公司有潜力，值得一试。祝你好运，让我们知道。

syhorchid

谢谢分享

coriolan

翻译的也看不明白，还是慢慢去看英文的吧{:soso_e115:}