Good Manufacturing Practice: The DNA of Pharmaceutical Quality

Good Manufacturing Practices or GMP's are the pharma industry’s fundamental guidance set up by regulatory authorities to describe what is necessary to manufacture safe, effective drugs. Essentially, GMPs (referred to as current Good Manufacturing Practices or cGMPs in the U.S.) provide a framework of manufacturing best practice standards that pharmaceutical processors are compelled to adopt and incorporate into their drug-making processes.

GMPs, as promulgated, are intended not to be prescriptive. To be compliant, drug manufacturers need to demonstrate to regulators that their drug-making processes within the production environment meet what the industry recognizes as best practice, not what regulators tell you they are. In other words, GMPs guide pharma manufacturers on what they should do, not how they should do it. By design, these regulating standards prompt drug manufacturers to assure drug quality and therefore drug safety, by incorporating the best, most up-to-date manufacturing technologies and processes into their standard operations.