Never Discard Rejected Materials in General Trash Bins

Rejected Materials Must Not Be Thrown into General Waste Bins

Remember: Discarding rejected materials in general trash is a serious GMP violation—use designated, controlled disposal procedures.

Why This Matters in GMP

Rejected pharmaceutical materials, whether due to contamination, deviation, or quality failure, must be handled with utmost care. Disposing of these materials in uncontrolled trash bins increases the risk of misuse, re-entry into production, contamination of other products, and environmental hazards. It undermines traceability and opens the door to product diversion or counterfeiting. GMP requires full accountability for all materials from receipt to disposal. Proper disposal of rejected goods ensures they cannot be mistaken for approved materials and supports a secure supply chain. Disregarding this practice reflects poorly on a facility’s quality culture and can lead to severe consequences during inspections.

Also Read: How to Achieve GMP Compliance for IMPs in Regulated Markets

Regulatory and Compliance Implications

FDA 21 CFR Part 211.94 and 211.192 require clear identification and proper disposition of rejected materials. WHO GMP and Schedule M emphasize controlled destruction and segregation of non-conforming products. EU GMP mandates secure handling and documentation of rejects to prevent unintended use. Regulatory agencies often inspect waste areas, destruction records, and the flow of rejected materials. Improper disposal is treated as a critical non-compliance issue, possibly resulting in Form 483s or warning letters. All rejected goods must be quarantined, documented, and destroyed under QA supervision, with destruction records traceable and retained for audit purposes.

Implementation Best Practices

Designate secure, labeled containers for rejected materials—never mix with general trash.
Maintain a rejection log that includes batch numbers, reasons, quantities, and disposition methods.
Implement SOPs for rejection handling, including QA approval before destruction.
Train staff to immediately segregate rejected goods and report them to QA.
Use incineration, shredding, or validated destruction vendors with certificates of disposal.

Also Read: Avoid Operating Equipment Without Completing Logbook Entries

Regulatory References

FDA 21 CFR Part 211.94 – Drug Product Containers and Closures
FDA 21 CFR Part 211.192 – Production Record Review
WHO GMP – Control of Rejected Products
Schedule M – Disposal of Waste and Rejected Materials
EU GMP Chapter 5 – Production