Never Handle Rejected Goods During Active GMP Production

Rejected Goods Must Not Be Handled During Batch Production

Remember: GMP requires that rejected goods be segregated and not accessed during live production to prevent cross-contamination or mix-ups.

Why This Matters in GMP

Rejected materials, whether due to deviation, damage, or test failure, are considered unfit for use. Handling or moving them during live production activities increases the risk of mix-ups, contamination, or inadvertent use. Even visual confusion between approved and rejected goods can compromise batch integrity. GMP protocols demand strict physical and procedural segregation of rejected materials in designated “REJECT” areas. Handling these goods during production undermines traceability, distracts personnel, and creates quality assurance blind spots. Controlled access and isolation ensure product safety and regulatory confidence.

Also Read: Assign Identification Numbers to All Cleaning Tools for Traceability

Regulatory and Compliance Implications

FDA 21 CFR Part 211.89 requires rejection and segregation of components not meeting acceptance criteria. EU GMP Chapter 5 calls for physical separation of rejected and approved materials to avoid cross-use. WHO GMP reinforces the need to mark and store rejected goods in restricted-access zones, and Schedule M outlines procedures to ensure rejected items do not interfere with routine production operations.

During audits, inspectors often ask for material handling SOPs, logs of rejected goods, access records, and production floor layouts. Evidence of rejected materials being moved, rechecked, or stored near production lines without QA authorization is considered a serious compliance breach. It can also lead to invalidated batch records, poor documentation practices, and even recall scenarios if product quality is compromised. Rejected goods should only be evaluated or moved under QA supervision and only when production is not in session.

Also Read: Health Canada GMP Guidelines for the Manufacture of Sterile Products

Implementation Best Practices

Designate and clearly label rejection zones physically separated from active production areas.
Restrict access to these zones to QA personnel or authorized staff with documented intent.
Update SOPs to prohibit any handling, sampling, or re-evaluation of rejected goods during production hours.
Log every interaction with rejected materials, including reason, personnel involved, and approval reference.
Conduct periodic internal audits to verify that rejected goods are not stored near WIP (work-in-progress) areas.

Regulatory References

FDA 21 CFR Part 211.89 – Rejection of Components and Drug Product Containers
EU GMP Chapter 5 – Production: Segregation of Materials
WHO GMP – Handling of Rejected Materials
Schedule M – Control and Storage of Rejected Goods

Also Read: Never Skip Microbial Monitoring in Critical GMP Zones