Tuesday, 9 March 2021 14.00 - 15.30 h
GMP News |
CDER Guidance Agenda Published |
Guidelines regarding GMP can be found in the "chemistry" category. An example for this is a guideline on Change Control, which will bear the title "CMC Post-Approval Changes Reportable in an Annual Report". Another planned document concerns sterilisation for registration purposes ("Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes"). The most important "GMP category", however, is the "compliance" category. It includes the following publications:
As in the past years, the revision of the Process Validation Guideline is on the agenda again. To manufacturers of combination products (medical devices with medicinal products), another expected guideline will be of interest: Drug Diagnostic Co-Development. The complete list of planned guidelines can be found at:
http://www.fda.gov/cder/guidance/CY08.pdf |