Audit Report

EAG Laboratories JA – 836

Audit #: JA - 836
Region: United States
Material: API/Excipients
Company: EAG Laboratories
Location: 7220 E ABC Lane Columbia MO 63202
Date: 11 July 2017

This Rx-360 Audit Report contains the following scope:

The scope of the audit includes the review of quality systems that support drug development services (combination of labs and GMP production areas)
1. Analytical method development and method validation
2. Stability testing and QC release
3. Impurity identification and characterization
4. Extractable and leachable testing

  1. Custom synthesis
    6. Radiolabeling

 

Using the audit document based on Rx-360 Consortium guidelines for Active Pharmaceutical Ingredients and the Rx-360 Supply Chain Security Checklist 2.0.