Use Material Transfer Notes (MTNs) When Moving Raw Materials

Do Not Move Materials Without a Valid Material Transfer Note

Remember: Always accompany material movement with an authorized MTN to preserve traceability and control.

Why This Matters in GMP

Material Transfer Notes (MTNs) serve as vital documents that authorize and document the movement of raw and packaging materials within GMP facilities. Unauthorized or undocumented movement poses significant risks including cross-contamination, mix-ups, inventory discrepancies, and non-traceable material usage. Without MTNs, it becomes challenging to track who moved the material, where it was sent, and whether it was handled correctly. This can result in mislabeling, stock variance, or even use of wrong-grade materials in production. A missing MTN may derail root cause analysis during deviation investigations or raise red flags during audits. MTNs reinforce transparency, accountability, and flow control across departments.

Also Read: How to Integrate Risk-Based Approaches in Continuous Improvement for GMP

Regulatory and Compliance Implications

GMP regulations (FDA 21 CFR Part 211.80 and 211.105, EU GMP Chapter 4, Schedule M) require complete records of material movement and usage. These include labeling, status, and traceability from receipt to dispensing. Failure to document transfers using MTNs has resulted in audit citations for poor inventory control and material traceability lapses. Regulatory bodies expect documented evidence of authorized material movement, including person responsible, material description, batch number, and destination. MTNs also play a critical role during investigations and batch release reviews, validating that materials used were approved, within expiry, and handled per SOPs.

Implementation Best Practices

Implement pre-numbered, carbon- MTNs authorized by warehouse and production heads.
Include key details: material code, quantity, batch number, source/destination area, and approval signature.
Digitize MTNs for traceability and linkage with inventory management systems.
Train staff on SOPs for material issuance, return, and destruction using MTNs.
Keep MTN records retrievable for at least the full product lifecycle per GMP archiving norms.

Also Read: The Future of GMP in the Global Pharmaceutical Supply Chain

Regulatory References

FDA 21 CFR Part 211.80 – General Requirements for Components and Drug Product Containers and Closures
FDA 21 CFR Part 211.105 – Identification of Components
EU GMP Chapter 4 – Documentation
Schedule M – Material Management and Warehousing