Quality by Design (QbD) in the pharmaceutical industry is a push from the United States Food and Drug Administration (FDA) towards a level of process understanding that would result in assured product quality while the product is being manufactured, rather than Quality by Inspection (QbI) which takes place after the product is completed. This means that pharmaceutical companies would have to have intricate knowledge of the design process and be able to analyze the components during manufacturing, as opposed to relying on final product testing to assess the quality of the product.
In order for the developers to produce this desired state of product, they need to have a complete understanding of all the pieces involved in the process, both of the raw materials and the intermediates as well as the interactions between the two. In other words, they must understand how the Critical Process Parameters (CPP) affects the variability in the Critical Quality Attributes (CQA) so that these can be measured and controlled in the manufacturing process. The solution needed to identify and analyze products in real-time is the ASPEX® Rx for the Personal Scanning Electron Microscope (PSEM).
ASPEX® Rx allows manufacturers a way to identify and analyze foreign particles in the production process by using the automated analysis to acquire images, morphology and elemental composition information with a dedicated interface. By allowing for quality control through the product stream, manufacturers can quickly identify foreign particles that would otherwise compromise their product’s quality. And since ASPEX® Rx can identify particles as small as 0.1 microns, it is an ideal tool for microcontamination quality control.
The benefits of the FDA’s QbD to the business are plentiful. Since these products by their very design are superior quality, there is a reduced failure rate in the product batches. Also, since there is less need for final product testing, which can end up costing the manufacturer and the consumer money, the cost of operations and the cost of the product could be lowered. Since there is also increased predictability of product quality in the manufacturing process, there can also be faster approval for new products.
The advantages to QbD in the pharmaceutical field, while changing the way manufacturers think about product production, can greatly outweigh any upfront costs that are needed to see the system put in place. ASPEX® Rx for the PSEM is an affordable micro contamination analysis solution for manufacturers to comply with the FDA’s QbD standards.
References:
Aspex Rx, http://www.aspexcorp.com/products/rx.html
NGP(http://www.ngpharma.com)
Pharmaceutical Processing (http://www.pharmpro.com)
