Biopharmaceuticals, also known as biological drugs or biologics, are manufactured from living organisms, or contain living organisms that have been genetically engineered to prevent or treat diseases.

The manufacturing industry, stock market, and new product development have really taken off in the past four years, and there’s a lot of focus now on moving offshore manufacturing back into the United States.

As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations.

Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!

Software as a medical device (SaMD) is a growing sector in medical device technology.

According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from

In May 2019, a California jury found Monsanto’s weed killer, Roundup, to be a “substantial factor” in the cancer suffered by a couple and ordered the U.S. agrochemical company to pay them $2 billion in damages.

The food industry is evolving rapidly, with consumers demanding quality, authenticity, and transparency from food manufacturers.

On May 26, 2020, the new European Union Medical Device Regulation (MDR) will finally take effect.

In our constantly evolving, data-rich universe, collecting, interpreting, and understanding process data can be tricky. But it is increasingly important if we want to maintain sustainable quality across product development and manufacturing processes.