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AUDIT COMPLIANCE REPORT USE OF EXPIRED RAW MATERIALS

July 2, 2026

Context of Observation :

During the WHO GMP inspection of the AABBCC pharmaceutical manufacturing facility, inspectors observed that expired raw material(s) were present in the manufacturing or warehouse system and there was inadequate assurance that only approved materials within their assigned expiry or retest period were available for dispensing or use. This raised concerns regarding material control, inventory management, status segregation, and compliance with Good Manufacturing Practices.

Immediately following the observation, Quality Assurance (QA), Warehouse, and Production initiated a joint investigation. All potentially affected raw materials were identified, physically segregated, and placed under QA control pending verification. A retrospective review of inventory records, ERP transactions, dispensing logs, Batch Manufacturing Records (BMRs), analytical records, and warehouse status labels was initiated.

The investigation confirmed that the observation represented a deficiency in material lifecycle control and required strengthening of procedural and operational controls. Where retrospective review identified no actual use of expired material in released batches, this conclusion was documented with supporting evidence. Where any actual use was identified, affected batches would be immediately placed under investigation and dispositional in accordance with the quality management system.

2. Root Cause Analysis (Detailed)

A multidisciplinary investigation using the 6M methodology was performed.

A. Man (Personnel)

Warehouse personnel did not consistently verify expiry or retest dates before dispensing.
Supervisory checks were not uniformly documented.
Refresher training on FEFO (First-Expire-First-Out) and material status verification was inadequate.

B. Method (Procedure)

Existing SOPs did not require an independent second-person verification of expiry/retest dates before material issuance.
Escalation procedures for approaching expiry materials were not sufficiently defined.
Periodic reconciliation of expiring inventory was not consistently performed.

C. Machine/System

ERP or inventory management alerts for approaching expiry were not fully utilized or configured.
Manual controls were relied upon for certain warehouse transactions.

D. Material

Retest dates on some containers were not prominently visible after repeated handling.
Temporary relabeling practices required enhancement.

E. Measurement

Internal audits did not specifically verify expiry status management.
KPIs related to expired inventory and FEFO compliance were not routinely monitored.

F. Management

Management Review Meetings did not include trending of expiring inventory or warehouse material status metrics.
Effectiveness checks for inventory control procedures were limited.

Root Cause Conclusion

The primary root cause was insufficient procedural controls and supervisory verification to ensure systematic prevention of dispensing or use of expired materials, combined with inadequate inventory monitoring and periodic review mechanisms.