Quality by Design (QbD) refers to the strategies developed and advanced by the US Food and Drug Administration, the International Conference on Harmonisation (ICH), and the United States Pharmacopeia (USP),^1-5 based on scientific principles and risk assessment and focused on product and process understanding.

On the 3rd June, 2013, United States Pharmacopeia (USP) published the revised mandatory Chapter 41 on balances as well as new updates to the advisory Chapter 1251. With just six months to comply, METTLER TOLEDO’s global weighing standard, GWP®, can help pharmaceutical manufacturers and suppliers to meet the new requirements.

The Thermo Scientific iCAP 6000 Series ICP-OES and Thermo Scientific iTEVA Software are ideal for the analysis of trace elements in pharmaceutical products.

To date, we’ve experienced a year of mega-mergers with six of the top pharmaceutical players combining forces to become three major contenders. What does this mean for the affected employees and managers alike? Well, believe it or not, it can lead to employment opportunities and personal successes that otherwise may not have been considered.

Like other new tools in the drug discovery process, automation, implemented properly, can generate the insight necessary to drive the pharmaceutical business forward.

The FDA has increased its focus on modernizing the regulation of pharmaceutical manufacturing and drug product quality. As a result, innovative pharmaceutical companies are re-examining whether traditional drug development and commercialization processes are sufficient.