Manufacturing And Quality Problems In Pharmaceutical Manufacturing

By Bruce Rehlaender, Ph.D., Director, Formulation Development, and Richard Soltero, Ph.D., President, PharmaDirections, Inc.

Many pharmaceutical and biotech companies put their trust in contract manufacturers when they outsource their GMP production. Even through there are many controls as part of Good Manufacturing Procedures, there are often problems that surface. One of the best ways to overcome problems is to first understand what they are. To this end we collected background information for an article comparing traditional paper-based pharmaceutical manufacturing with electronic manufacturing using an internet survey. We used this survey to ask “what were your most serious manufacturing and quality problems you have seen. The survey was sent to experts in manufacturing and quality assurance. This article summarizes their answers about the most serious productions problems they faced and how quality could be improved when an electronic manufacturing execution system is used.