The c in cGMP

C (little c) could stand for so many things, but in the GMP world, it stands for “current” meaning FDA’s current interpretation of Good Manufacturing Practices. The c comes up in many publications and conferences, but most of all in Guidances. FDA just published their guidance on GMPs for Cell and Gene Therapy, “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications,” which contains a wealth of information for the CMC part of INDs and by extension, good information for the CMC part of new BLAs for gene therapies.