This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.
How a proactive approach involving predictive — rather than preventive — tools to identify deficiencies before they compound and become actual problems can result in a healthy bioprocessing facility.
Changing existing or creating new documentation typically involves multiple disciplines and can have long lead times. CRB was able to help a biotech company improve their Global Documentation Change Control Process quickly and easily.
Is your team ready to manufacture larger batch sizes to support if Phase III studies are on the horizon?
Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult. Read on to understand strategies, frameworks and recommendations to achieve these goals.
While there are a certain amount of commonalities in regulations in each country, there are differences which necessitate care from global manufacturers when distributing products.
Real-time release testing can be defined as a set of in-process controls that may provide greater assurance of product quality than end-product testing.