Manufacturing Batch Record Review

Your Manufacturing Batch Record is reviewed by a Certified Quality Specialist. We provide a Batch Record Review Summary and a recommendation to release or not release the manufactured lot.

Deliverables Include:

• An easy to navigate summary page
• Recommendation to release/not release (product disposition)
• Clearly identified errors & missing information
• Recommendations for improvement
• A batch record review documentation packet
• Review of deviations, CAPAs, OOT/OOS, & nonconformances

This service is perfect for a small company just starting out or a large company with a backlog of quality records. 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.