It’s not easy to cross-reference FDA regs and guidance on the FDA website: CGMP Concise Desk Reference Needed
Originally posted November 9, 2009
The FDA website is designed to allow the user to search on terms only within the sections the user specifies. This means we frequently miss, or are not aware of, all of the regulations and guidance documents that apply to us in industry. The pocket CFR manuals available at conferences and training events are not easy to search and don’t include all of the information we need. This book fills in the gaps.
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“Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference” (634 pages)
Included Reference Tools: