If you go back to the latter part of the 20th century, the pharmaceutical industry was very vocal about the challenges of operating a global business successfully, in an environment of often regional GMP regulations.  In an attempt to harmonize these practices, an informal ICH working group, in July 2003, agreed on a vision to develop a pharmaceutical quality system that would be applicable across the entire lifecycle of a product.  They wanted to emphasize an integrated approach to quality risk management mixed with science.  But did they achieve their goals?

What the committee wanted to achieve was the ability to focus on the entire lifecycle of the product, not just manufacturing.  Because the linkage between development and commercial manufacturing is so critical to the successful introduction of a product, and the successful transfer of knowledge, there was no doubt that something had to be done.  In the end, the EWG wanted to augment regional GMP regulations and move from GMP compliance to robust process understanding.  Any good pharmaceutical consultant will tell you that knowledge management, knowledge transfer, and technology transfer, are key aspects of Quality Systems Management.

There has always been a fear in the industry that too many companies were taking commercial GMP requirements and forcing them upon development and manufacturing activities.  That is why it is so important for the elements of the new system to be applied in a manner that is appropriate and proportionate to each product lifecycle stage.  This is why the old system was broken because it failed to recognize the fact that the goal of development is oftentimes much different than the goal of manufacturing.

However, these new guidelines do not replace existing GMP regulations, but rather are used in accordance with the existing regulations.  Because regional GMPs don’t necessarily address all stages of the product lifecycle, nor promote innovation or continual improvement, it is important to take this overall step towards a more quality controlled environment.  Under the new quality control system, the system encourages more use of science and better use of risk-based approaches at every stage of the life cycle.  Using this new system promotes better quality and initiates continual improvement across the product lifecycle, resulting in better quality.  By using innovative methods like these, there is no doubt the pharmaceutical industry is well on its way to achieving the kind of process control and quality that is expected in the 21st century quality system approach.

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