[BOOK][B] Good manufacturing practices for pharmaceuticals

JD Nally - 2016 - taylorfrancis.com
With global harmonization of regulatory requirements and quality standards and national
and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers …

22 FDA Pre-Approval Inspections/Investigations: The Road from Scale-Up and Post-Approval Changes to the Food and Drug Modernization Act

JD Nally - Good Manufacturing Practices for Pharmaceuticals, 2007 - books.google.com
This guidance represents the (FDA's) current thinking on this topic. It does not create or
confer any rights for or on any person and does not operate to bind the FDA or the public …