Do Not Stockpile Rejected Units in Pharmaceutical Dispensing Areas

Rejected Units Must Not Be Stored in Dispensing Areas

Remember: Rejected materials should be promptly removed from dispensing areas to prevent mix-ups, cross-contamination, or unauthorized usage.

Why This Matters in GMP

Dispensing areas are reserved for handling approved materials that meet all quality specifications. Keeping rejected materials in such zones increases the risk of mix-ups, unintended use in production, and product quality compromise. These materials may be visually similar to approved lots, making it difficult to distinguish without rigorous checks. Their presence in active workspaces undermines segregation controls and raises serious contamination and traceability concerns. GMP requires immediate removal of rejected goods to designated quarantine or rejection areas with appropriate labeling. Stockpiling such items in the dispensing zone reflects a breakdown in material control and quality assurance.

Also Read: How Schedule M (Revised) GMP Guidelines Ensure Safety in the Manufacturing of Injectable Products

Regulatory and Compliance Implications

FDA 21 CFR Part 211.42 and 211.80 mandate segregation of rejected materials to prevent their reuse or accidental dispensing. WHO GMP and Schedule M emphasize immediate labeling and physical separation of non-conforming materials. EU GMP expects clear zoning and control over material flow to ensure product safety. Auditors inspect material movement logs, rejection records, and area practices. Rejected goods found near dispensing operations may lead to Form 483 observations, recalls, or production holds. Proper segregation ensures batch integrity and prevents reprocessing without formal investigation and QA approval.

Implementation Best Practices

Label rejected units clearly and transfer them immediately to designated rejection areas.
Restrict access to rejected goods and ensure their records are updated in the inventory control system.
Train staff on immediate reporting and handling procedures for non-conforming materials.
Install visual indicators (e.g., red tags, rejection bins) in dispensing areas to prevent confusion.
Include rejection logs and movement records in QA oversight and internal audits.

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

Regulatory References

FDA 21 CFR Part 211.42 – Design and Construction Features
FDA 21 CFR Part 211.80 – General Requirements for Components
WHO GMP – Section 5.22: Control of Rejected Materials
Schedule M – Handling of Rejected Goods
EU GMP Chapter 5 – Production