Pharma-Grade Raw Materials: COA, TDS & SDS
Documentation essentials for regulated markets and how to verify batch consistency.
Why Documentation Matters
Regulated markets require complete, verifiable batch documentation. Strong document control reduces release delays, deviations, and audit findings.
What to Check
- COA: Batch assay, impurities, residual solvents, micro limits, and compliance to specs.
- TDS: Typical properties, use, compatibility, and storage/handling guidance.
- SDS: Hazards, PPE, first-aid, spill response, and transport classification.
Traceability & Change Control
- Unique lot IDs linked to manufacturing records.
- Change notifications for site/process/spec updates.
- Supplier qualification, re-qualification, and audit cadence.
Best Practices
- Cross-check COA specs vs. monographs and internal limits.
- Control revisions; archive superseded documents.
- Trend critical attributes to detect drift early.