Ultimate Solid Oral Dose Audit Tool

If you’re preparing for an FDA inspection of your Oral Solid Dose (OSD) facility, this audit tool is your secret weapon. Designed by former FDA Investigators and seasoned pharmaceutical industry experts, it shows you exactly what to look for—what FDA finds, how they find it, and how to correct it before they show up.

Whether your operation includes tablets, capsules, or modified-release products, this tool walks through all the critical systems and operations that FDA routinely inspects:

✔️ Granulation
✔️ Compression
✔️ Encapsulation
✔️ Coating
✔️ Cleaning validation
✔️ Environmental controls
✔️ Equipment qualification
✔️ Process validation
✔️ Data integrity
✔️ Stability programs
✔️ SOPs and recordkeeping

This is not generic guidance or a regulatory copy/paste. It is a field-tested, inspection-style roadmap with targeted questions, how to verify compliance, and specific examples of what FDA commonly cites.

Perfect for:

• QA Managers
• Internal Auditors
• Regulatory Compliance Teams
• Consultants
• Pharma Executives preparing for FDA audits or pre-approval inspections (PAIs)

Bonus:
This tool also trains your internal auditors to audit like the FDA does. It provides:

• Structured prompts modeled after FDA-483 observation language
• “How to Verify” sections that mimic FDA’s evidence-gathering approach
• “Common Deficiencies” summaries aligned with actual Warning Letter findings

It can be used to perform risk-based internal audits, vendor evaluations, and mock inspections that truly reflect FDA expectations.

Get your hands on what the FDA would ask—before they ask it.

🧠 Based on real-world audits
📋 Structured to reflect actual FDA inspection methodology
🚫 Not AI-generated fluff — built by professionals who’ve conducted FDA inspections