Assign QA Oversight to Product Destruction Activities in GMP

Remember: Product destruction must always be supervised and documented by QA to ensure traceability, prevent misuse, and maintain GMP compliance.

Why This Matters in GMP

Rejected products, expired drugs, or returned goods must be destroyed in a controlled manner to prevent reentry into the supply chain. Improper or unsupervised destruction risks contamination, regulatory breaches, or intentional misuse. Without QA oversight, it is difficult to verify whether destruction was complete, traceable, and aligned with SOPs. QA plays a central role in authorizing destruction, ensuring accurate documentation, and verifying that the disposal method complies with local environmental laws and GMP protocols. Destruction is not just a physical act—it is a quality-critical process that must be safeguarded.

Regulatory and Compliance Implications

FDA 21 CFR Part 211.208 mandates that returned or rejected drug products must be destroyed in a manner approved by the quality unit. EU GMP Chapter 5 and Chapter 8 require that rejected products be securely destroyed with QA involvement and proper records. WHO GMP recommends oversight of destruction operations to prevent unauthorized use and ensure documentation. Schedule M also specifies that destruction activities be carried out under the direct supervision of QA with supporting records.

Auditors review destruction logs, witness reports, deviation records (if any), and contracts with third-party disposal agencies. Absence of QA in destruction or incomplete documentation is a frequent cause of regulatory observations. In severe cases, unverified destruction can result in product diversion or counterfeiting in the market. QA’s involvement ensures the destruction is conducted ethically, securely, and in line with the organization’s quality system.

Implementation Best Practices

• Prepare a destruction plan detailing product name, quantity, reason for destruction, and method.
• Have QA authorize and witness the destruction process; both QA and operations must sign records.
• Use tamper-evident seals and barcodes to track rejected goods from warehouse to disposal site.
• Involve authorized third-party vendors only after qualification and QA approval.
• Archive certificates of destruction and attach them to corresponding batch records or QA logs.

Regulatory References

• FDA 21 CFR Part 211.208 – Returned Drug Products
• EU GMP Chapter 5 – Production and Quality Control
• EU GMP Chapter 8 – Complaint and Product Recall
• WHO GMP – Disposal of Rejected Products
• Schedule M – Disposal and Destruction under QA Supervision