GMP Audit Checklist – Storage of Starting Materials

1. Storage Area Design & Conditions

• Is the storage area clean, well-lit, pest-free, and secure?

• Are temperature and humidity continuously monitored and recorded?

• Are conditions maintained as per material storage requirements (e.g., controlled room temperature, cold storage)?

• Are alarms and alerts in place for excursions (e.g., temperature deviation)?

• Is there segregation of different types of materials (e.g., APIs, excipients, solvents, packaging)?

2. Identification & Segregation

• Are materials clearly labeled with name, batch/lot number, status (quarantine, released, rejected)?

• Is there physical and/or electronic segregation between quarantined, released, and rejected materials?

• Is there a dedicated area for returned or recalled materials?

• Are flammable or hazardous materials stored in suitable cabinets/rooms?

3. Receipt & Sampling

• Are incoming materials inspected for damage, contamination, and integrity before storage?

• Is sampling done in controlled, designated areas to avoid contamination?

• Is sampled material resealed and properly labeled after sampling?

• Are materials only moved to approved storage areas after proper checks?

4. Stock Management

• Is FIFO (First-In-First-Out) or FEFO (First-Expiry-First-Out) system followed?

• Are expired or nearing expiry materials handled according to SOPs?

• Is stock rotation documented properly?

• Are partial containers re-labeled and re-sealed appropriately?

5. Documentation & Traceability

• Are Material Receipt Records maintained (with supplier, batch, COA details)?

• Are warehouse logs contemporaneous, complete, and accurate?

• Are all movements (receipt, sampling, issue, return) documented and traceable?

• Are materials linked to approved suppliers and COA verified before use?

6. Cleaning & Hygiene

• Is there a cleaning schedule for storage areas (including floors, racks, walls)?

• Are cleaning records maintained and signed?

• Is there a pest control program with records?

• Are personnel following gowning and hygiene practices when entering storage areas?

7. Equipment & Monitoring

• Are storage racks, pallets, and containers made of suitable GMP-compliant material?

• Are monitoring devices (temperature/humidity loggers, alarms) calibrated?

• Is equipment like forklifts or trolleys clean and maintained?

• Is there backup (e.g., generators) for refrigerated or controlled areas?

8. Regulatory Compliance

• Do storage practices comply with cGMP and pharmacopeial guidelines?

• Is there compliance with supplier qualification requirements?

• Are audit findings or deviations related to storage investigated and closed?

✅ Key Objective: Ensure that starting materials are stored in a controlled and compliant manner, preventing contamination, mix-ups, or deterioration before use in manufacturin

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