In GMP manufacturing, batch records are essential to guarantee process traceability, reproducibility, and audit readiness. Munit integrates comprehensive batch documentation into all its API micronization and powder handling workflows.
What Are Batch Records?
Batch records document the entire manufacturing process — from raw material handling to final product release. This includes equipment logs, in-process controls, cleaning steps, and analytical results, aligned with EU GMP Part I & II.
Munit’s Approach to Documentation
Our team provides fully validated, audit-ready batch records for every project, including:
- Master and executed batch records
- Cleaning and equipment logs
- Analytical results (PSD, OEL, etc.)
- QA approvals and change control
All documentation supports client QPs, regulators, and internal QA teams.
Traceability and Compliance
We ensure full traceability from incoming material to product dispatch, using lot coding, retained samples, and version-controlled documentation — helping our clients meet both regulatory and internal quality goals.
Choose a partner who delivers on documentation.
Talk to Munit about batch record compliant processing.