Never Move Unverified Materials to GMP Dispensing Areas

Unverified Materials Must Not Enter GMP Dispensing Areas

Remember: Only QA-released and verified materials should be moved to dispensing—unverified items are a serious GMP risk.

Why This Matters in GMP

Dispensing is the first step in manufacturing, where materials are measured for batch production. Introducing unverified or unapproved materials into this stage can result in batch contamination, deviation, or recalls. Verification confirms identity, quality, and compliance with specifications, and must be completed by QA. GMP requires physical and documented control of material status—unverified items must remain in quarantine. Moving such items prematurely breaks traceability and compromises batch records. Facilities must enforce controls to ensure only materials with formal QA release labels are permitted in dispensing zones.

Also Read: The Role of CAPA (Corrective and Preventive Actions) in Continuous Improvement for GMP

Regulatory and Compliance Implications

FDA 21 CFR Part 211.84 requires testing and approval of components before use. EU GMP Chapter 5 mandates that only released materials be used in manufacturing. WHO GMP and Schedule M emphasize material quarantine and QA clearance before transfer to production. Regulatory audits focus on warehouse movement records, material status labeling, and dispensing controls. Unauthorized use of unverified materials is a critical GMP violation that can trigger 483s, warning letters, or product holds. QA must verify and document material approval before any movement.

Implementation Best Practices

Clearly label material containers as “Quarantined,” “Approved,” or “Rejected.”
Use warehouse access controls and movement logs to prevent unauthorized transfers.
Maintain electronic or manual QA release records linked to each material lot.
Train warehouse and production staff to check QA approval before initiating dispensing.
Establish barcode or RFID systems to prevent accidental movement of unverified stock.

Also Read: Prohibit Forklift Use in Primary Packaging Areas to Prevent Contamination

Regulatory References

FDA 21 CFR Part 211.84 – Testing and Approval of Components
EU GMP Chapter 5 – Production
WHO GMP – Warehouse and Material Control
Schedule M – Material Quarantine and Release Procedures