Case mock-ups bring QbD to life

Mock implementations of quality by design processes, based on actual projects underway, may help bridge the gap between big pharma companies that have the resources to participate in its development and smaller players waiting for signs that QbD will work for them. The implementations were presented at a meeting hosted by the Parenteral Drug Association and EFPIA, the European drug industry association. Article

Suggested Articles

Drugmakers have voluntarily recalled their generic Zantac from the U.S. market after the FDA raised concerns, but it has not been without a cost.

Just weeks after selling the sterile manufacturing assets of its Kyowa operation in Japan, it has unloaded the rest of its Kyowa drugmaking operation.

India’s Aurobindo, which has yet to close its $1 billion deal to buy 300 Sandoz products in the U.S., continues to rack up FDA issues.