The Ultimate API Audit Tool

This professional-grade audit tool was developed by multiple former FDA Investigators to help pharmaceutical manufacturers evaluate and strengthen their Active Pharmaceutical Ingredient (API) operations. Aligned with FDA regulations (21 CFR 211) and ICH Q7 expectations, this tool is ideal for internal audits, mock FDA inspections, supplier assessments, and inspection readiness activities.

Whether you're manufacturing in-house or relying on third-party API suppliers, this tool guides you through:

• Facility and equipment compliance
• Cleaning validation and contamination control
• Process validation and critical process parameters
• Raw material and impurity control
• Data integrity, batch records, and laboratory practices
• API stability, storage, and handling
• Supplier qualification and material traceability

Includes fillable fields for capturing observations, assigning responsibilities, and documenting audit outcomes. Also highlights common FDA deficiencies seen in API audits.

If API compliance is mission-critical to your operation, this tool ensures you audit like the FDA does.