ALC - BioAgil

Production and sale of therapeutic drugs requires tight control over the manufacturing, processing, and labeling of these products to ensure the safety of the end user. In the United States, regulations for maintaining the quality of medications such as these are under the jurisdiction of the Food and Drug Administration (FDA). They are referred to as Good Manufacturing Practice (GMP) or Current Good Manufacturing Practice (CGMP) regulations. GMP regulations mandate that manufacturers demonstrate the safety, purity, and efficacy of drug products during clinical testing and after drug approval. These regulations include having suitable quality management systems in place, ensuring the integrity of materials used, establishing appropriate operational processes, and using compliant laboratory facilities to support product characterization and testing. These are considered minimum requirements but are broad reaching, spanning from the proper maintenance and calibration of equipment to the acceptable performance of an analytical test for measuring drug purity. Ultimately, the GMP regulations are designed to address the full manufacturing process, maintain quality drug products, and protect consumers.

As we look towards the development of the next generation of drugs and therapies, it starts to beg the question of whether we are creating the next “cure” or the next “treatment.” A cure would require actively restoring the patient to full health with no disease left whereas a treatment shows an improvement in health but the underlying disease still remains. Both cures and treatments are obviously important but the goal of actively curing a disease remains the ultimate outcome we strive to achieve. However to develop a cure is highly difficult thereby making treatments just as important to develop. A treatment could be a “bandage” on a problem while a cure is developed or implemented.