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QbD and QRM Implementation

Quality by Design (QbD) and Quality Risk Management (QRM)
Quality by Design (QbD) is a relatively new approach to product and process development for the (bio)pharmaceutical industry. It means that the design of a product or process is systematically and scientifically tested and revised before its large-scale production begins. This not only guarantees the development of a safe and effective product, it ensures that the process is robust, can be upscaled and is cost-efficient. Moreover, QbD fits in with the Quality Risk Management System (QRM) of an organisation.

Cost savings and greater potential success
Better flexibility in modifying and optimising registered processes is often claimed to be the greatest advantage. But the real advantages relate to cost savings. A process developed on the basis of a good product and process knowledge will result in fewer deviations and rejects. A shorter lead time can also be achieved. After an initial investment in the required tools (hardware, software and knowledge), process development according to QbD will result in a more efficient and effective working method. The potential success of introducing new products on the market can be increased.

A new way of working
The government and the industry expect QbD and Quality Risk Management (QRM) to be applied increasingly frequently during the development, registration, production and lifecycle of (bio)pharmaceutical products. That means that many companies in the industry will have to adopt a new way of working, necessitating a cultural change. This applies to all departments involved in the start of a product’s development to registration and implementation of production, from R&D and engineering right up to production, QC, QA and registration.

How can Progress-PME help you with this?
The professionals at Progress-PME can advise companies about the most effective implementation of QRM and QbD as well as help prepare the required business procedures and work documents. This can be done at the start of the development of a new product and process, as well as for a (sub) process of an existing product. Progress-PME recommends a top-down approach here. Commitment from top and middle management and the implementing parties is essential for the good implementation of these new methods.

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