Özet:

As is known, development of safe and efficient new treatments is a long, difficult and expensive process. Instead of testing the quality, with the usage of the new approach that asserting that quality should be provided by design within the product (QbD), quality is increased in the products manufactured, costs are lowered and also product release to the market is accelerated. As mentioned in ICH Q8 guideline, QbD is a systematic drug development approach starting with pre-defined purposes and focusing on ensuring that the product and process are understood based on solid science and quality risk management (1). QbD, as brought forward in this guideline, increases the information about the process, and helps for a better understanding of the product, and it can support this with the application of new technologies like PAT or modeling when necessary. By defending risk based approaches depending on science and scientific knowledge, it allows for ensuring pharmaceutical development, manufacturing and quality assurance. Two fundamental components of QbD are quality risk management and information management concepts.

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