Former FDA Official: Combination Products Guidance Expected Soon

The FDA will soon issue guidelines specific to combination products, resulting in increased regulatory action against cGMP violations, which will affect both laboratories and manufacturing divisions, a white paper by a former FDA official predicts.

“We expect this guideline will incorporate both [process analytical technology] and [design of experiments] requirements regarding both small-molecule and large-molecule process design and scale-up,” Steven Richter, president and chief scientific officer of Microtest Laboratories, wrote.

Manufacturers’ regulatory departments are struggling to address a multitude of testing guidelines, practices and regulations that are unique to combination products, the white paper said.

In a report cited in the white paper, Mike Treadway of The Tech Group said that one of the biggest challenges with combination products is making sure that quality systems are in place and compliant with regulatory requirements. There is a dichotomy between drug GMPs and medical device quality system regulations.

The white paper can be downloaded at www.microtestlabs.com/combinationpaper.