GMP Audit Check List- Storage of Starting Materials
🏭 GMP Audit Checklist – Storage of Starting Materials
1. Material Receipt & Identification
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✅ Are incoming starting materials received against approved suppliers and purchase orders?
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✅ Are materials inspected for damage, tampering, contamination, and labeling before acceptance?
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✅ Are quarantine materials physically or electronically segregated?
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✅ Are materials labeled with unique IDs, batch/lot numbers, and status (Quarantine/Released/Rejected)?
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✅ Is sampling done in a controlled area by trained personnel as per SOP?
2. Storage Conditions & Controls
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✅ Are materials stored under recommended temperature and humidity conditions?
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✅ Are temperature/humidity monitoring devices installed, calibrated, and records maintained?
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✅ Are mapping studies performed for warehouses, cold rooms, and freezers?
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✅ Is there an alarm system for excursions with documented corrective actions?
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✅ Are materials stored off the floor (on pallets/racks) and away from walls for cleaning & inspection access?
3. Segregation & Labeling
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✅ Are rejected, expired, or returned materials segregated in a controlled area?
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✅ Are hazardous, flammable, or light-sensitive materials stored as per safety guidelines?
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✅ Is there clear status labeling (“Quarantine,” “Released,” “Rejected”) for all containers?
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✅ Is FEFO/FIFO (First Expired/First Out or First In/First Out) system implemented?
4. Documentation & Traceability
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✅ Are warehouse logbooks and material movement records complete and contemporaneous?
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✅ Are electronic systems (ERP/SAP) validated and access-controlled?
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✅ Are inventory levels regularly reconciled with records?
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✅ Are deviations in material handling (spillage, mix-up, temperature excursion) documented and investigated?
5. Sampling & Dispensing Areas
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✅ Are sampling and dispensing areas controlled (dust extraction, gowning, cross-contamination prevention)?
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✅ Are balances calibrated before use in dispensing?
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✅ Is line clearance performed before each operation?
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✅ Are materials weighed/dispensed under proper labeling to avoid mix-ups?
6. Housekeeping & Safety
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✅ Are storage areas clean, pest-free, and free from unnecessary items?
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✅ Are pest control records up to date?
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✅ Are fire extinguishers, alarms, and safety signs available?
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✅ Is PPE used appropriately when handling hazardous materials?
7. Periodic Review & Compliance
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✅ Are materials periodically reviewed for shelf-life and retesting needs?
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✅ Are expired/rejected materials immediately labeled and stored in a separate controlled area?
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✅ Is there a system for disposal/destruction of obsolete materials?
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✅ Are GMP training records of warehouse staff current?
📌 Quick Pre-Audit Focus Points
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Material status labeling & segregation
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Temperature & humidity monitoring compliance
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Documentation completeness & traceability
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Expired/rejected materials control
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Sampling & dispensing hygiene
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