A New Approach to Quality Management Systems

When you get back in the second half of the 20th Go century, the pharmaceutical industry was very vocal about the challenges of successfully operating a global business in an environment often regional GMP regulations. In an attempt to these practices, I harmonize an informal working group in July 2003 agreed on a vision, a pharmaceutical quality, be applicable across the entire lifecycle of a product to be developed. They wanted to emphasize an integrated approach toQuality of risk management, mixed with science. But they have achieved their goals?

What the committee wanted to achieve was the ability to focus on the entire lifecycle of the product, not just production. Since the link between development and commercial production is so crucial for the successful introduction of a product, and the successful transfer of knowledge, there was no doubt that something needed to be done. At the end of the EEC wanted to expand regionalGMP standards and relocation of GMP compliance to understand robust process. Any good pharmaceutical consultant will tell you that transfer of knowledge and technology are the most important aspects of quality management systems.

It has always been afraid in the industry that too many companies that were commercial GMP requirements and force them to design and manufacture. That is why it is so important for theElements of the new system will be applied in a manner appropriate and proportionate to each product's life cycle stage. That is why the old system was broken, because they do not, the fact that the goal of development is often seen very differently than the goal of production.

However, these new guidelines are not to replace existing GMP regulations, but are used in accordance with applicable regulations. As regional GMP does not necessarily address allLifecycle of the product, or promoting innovation and continuous improvement, it is important to take this step towards a general quality-environment. Under the new system for quality control, the system prompts the use of science and better use of risk-based approaches at all stages of the lifecycle. With this new system promotes a better quality and initiates continuous improvement throughout the product life cycle, leading to better quality. By using innovative methods such asthis, there is no doubt that the pharmaceutical industry is on its way to achieving the kind of process control and quality, which in the 21 Century Quality System is expected approach.

If you liked this article to a pharmaceutical consultant, please feel free to them on your website or blog and forward this link to send to your friends. Have a great day!


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