Guidance: Makers of Key Drugs Need Emergency Production Plans

Drugmakers that are the sole or primary source for certain key drugs need to be able to continue production during a pandemic and should create emergency production plans that can delay or modify some good manufacturing practices (GMPs). Risk assessments are recommended to prioritize GMPs that might be delayed, substituted or reduced in case of severe absenteeism at one or more plants, and manufacturers should have well-supported conclusions that the actions won’t make products unsafe or ineffective, according to a draft guidance in the Jan. 8 Federal Register.
Drug Industry Daily