Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
|Articles|May 16, 2023
A Guide to Developing an Effective Cleaning and Disinfection Program in Aseptic Environments
Author(s)Contec
Regulatory agencies require pharmaceutical manufacturers to control the environments in which they produce finished products to ensure they are free of contamination. This is a guide to developing an effective cleaning and disinfection program.
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