Phase-Appropriate cGMP Comprehensive Guide

Phase-Appropriate cGMP Comprehensive Guide

I spent 14 years as an FDA Investigator and issued more Form FDA-483s than I care to count. For the 13 years afterwards including part of the team that navigated J&J out of consent decree, I was directly responsible for FDA-483s received.

One of the most common mistakes I saw across companies at every stage of the IND cycle: applying full commercial cGMP rigor to a pre-clinical program, or worse, applying pre-clinical laxity to a Phase III program headed toward an NDA. FDA's expectations scale with development phase. Most companies never get a clear, single reference for what that scaling actually looks like, stage by stage.

This guide fixes that. It walks the full clinical development lifecycle, pre-clinical through Phase III, and lays out exactly what FDA expects at each stage: documentation rigor, quality system maturity, analytical testing requirements, and the specific compliance expectations that shift as a product advances.

[This is an employer-reimbursable professional compliance resource. Send this page to your Quality Director, Site Head, Regulatory Affairs leader or Learning and Development department for approval.]

What's inside:

• A phase-by-phase breakdown of cGMP expectations from pre-clinical through Phase III
• Analytical testing requirements mapped to each phase of development
• A fully hyperlinked table of contents for fast navigation
• Fully developed prose sections, not just bullet-point summaries, so you can hand this directly to a team member or use it as a training reference
• Grounded throughout in FDA's actual enforcement patterns, not just the regulation text

Who this is for:

Quality and regulatory professionals at companies moving a product through clinical development who need a clear, defensible reference for what "phase-appropriate" actually means in practice, and consultants who need a credible deliverable to bring to clients navigating the same question.

This is the same standard I apply when advising clients directly. If you need this guide adapted to your specific program or a full gap assessment against your current phase-appropriate practices, reach out: devaughn@fdaid.org.