The pharmaceutical industry has always maintained a focus on quality; the risks are simply too high not to. However, we are now seeing an increased emphasis on tackling quality upfront in the pharmaceutical manufacturing process. This means introducing quality as a consideration during the R&D phase rather than waiting until the product is designed and then thinking about how quality will be maintained. After all, quality cannot be tested into a product, it should be there by design.
Quality by Design (QbD) is a systematic approach to product and process development that begins with predefined objectives and emphasizes product and process understanding, based on sound science and quality risk management.
Read the pdf version of the article Incorporating Quality by Design into Pharmaceutical Manufacturing which has been published recently in Manufacturing Chemist or visit the Manufacturing Chemist website