Expert review of master and executed batch records, deviations, analytical data, and Certificates of Analysis, so every lot is released with confidence.

What’s included

• Master Batch Records: Review of master records for accuracy and completeness.
• Executed Batch Records: Line-by-line review of completed batch documentation.
• Deviation Review: Check that deviations are documented, assessed and closed.
• Analytical Data: Review of test results and supporting data.
• Certificates of Analysis: Verification of CoAs against specifications.
• Release Decisions: Clear, documented support for product release.