A comprehensive new model has been introduced, for an effective pharmaceutical quality system that not only complies with the International Standard Organization (ISO), but includes the correct manufacturing regulations as well. This new guideline applies to the systems supporting the manufacture and development of pharmaceutical drug substances, including biotechnology and biological products throughout the product life cycle. By recognizing the differences between each stage of development, it allows manufacturers to recognize the different goals of each stage, further developing quality.
This is new system is quickly picking up steam in the life sciences consulting industry because it is a better overall system. They see this new system as an innovative approach to quality systems management because it enhances the quality and quantity of medicines around the world. Implementation of the new quality control system will facilitate innovation and continual improvement throughout the products’ life cycle, while at the same time strengthening the link between pharmaceutical development and manufacturing.
This kind of new quality risk management can also be extremely useful in identifying and prioritizing areas for continual improvement. To properly identify and implement appropriate product quality improvements, which is the goal of any pharmaceutical company, you need to increase the ability to fulfill needs consistently. And this is what this new system is trying to achieve.
By using these new knowledge based management systems and quality risk management systems effectively, companies will be able to implement these new strategies cost effectively and without incident. It is very important in this new system that quality risk management be an integral component. It can provide a proactive approach in identifying and scientifically evaluating potential risks to quality. This facilitates continual improvement of process performance and product quality throughout the entire life cycle of a product.
Using the correct quality risk management approach is extremely vital to the effectiveness of your pharmaceutical quality system. It is an important system in the process of acquiring a systematic approach to analyzing, storing and disseminating information related to products and manufacturing. Without it, it will be impossible to correctly develop activities using scientific approaches, and provide the correct knowledge for product and process understanding. The product and process knowledge should be managed through the entire development of the product’s life cycle, through the commercial life of the product all the way to the end of the product, including discontinuation. Without using this quality systems management approach, the product quality will suffer and so will the integrity of the company.
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