Scientific and Regulatory Affairs

GMP Comparison Worksheet

PDA is providing this worksheet as a supplemental tool for users of the Global Sterile Manufacturing Regulatory Guidance Comparison document. Included in the Microsoft Excel® file worksheet is an additional column for the user to enter notes regarding their company’s practices or compliance status related to the various guidelines presented. The original references and glossary are included for the U.S. FDA Guidance for Sterile Drug Products Produced by Aseptic Processing cGMP immediately follow the table.