Critical Supplier Audit
The FDA is cracking down on API suppliers. Almost daily, pharmaceutical firms broadcast recall alerts for their FDA approved drug products. The materials you use in your operation can make or break you. Hospitals and pharmacies may not have the time or be well-versed in GMP to conduct an adequate audit of a compounding material supplier. 503B outsourcing facilities and GMP manufacturing sites may also prefer to sub this work out to a competent GMP auditor so they can focus on mass production. Our auditors hold certified quality auditor (CQA) designation and have deep GMP experience. Don’t take time away from your operation. Let us take the guess work out of auditing your critical material suppliers.
What’s Included
Compliance Audit: Assess the Facility, Equipment, Training and Documentation, Process Controls, Finished Product Testing, and Quality Assurance Program
Findings Report
Remediations Recommendation