Product Release
Your manufacturing batch records are reviewed and released by a Certified Quality Specialist.
We review all the associated GMP manufacturing records against U.S. FDA requirements, product specifications, in-process test results, and industry standards.
Deliverables Include:
Batch Record Review Packet
Executive Summary
Recommendations for improvement
Review of deviations, CAPAs, OOT/OOS, & nonconformances
Streamline your product release process with our trained professionals. Our services can be further customized to focus on Batch Records, Supplier Records, Quality Investigations, Training Records, Packaging Records, or other GMP Records to support FDA regulated products.