Effective SOP for Good Warehousing Practices (GWP)
Learn how to design and write a SOP for Good Warehousing Practices (GWP) to ensure proper storage, handling, and distribution of pharmaceutical materials in warehouse.
1.0 PURPOSE
To describe the procedure and requirements for the receipt, storage, handling, and dispatch of raw materials, packaging materials, intermediates, and finished pharmaceutical products in compliance with Good Warehousing Practices (GWP).
2.0 SCOPE
This SOP is applicable to all personnel and operations within the warehouse areas involved in pharmaceutical warehousing at pharmaceuticals, including cold chain and controlled substances where applicable.
3.0 RESPONSIBILITY
3.1 Warehouse Officer/Staff is responsible to ensure receipt, storage, and dispatch of materials/products as per GWP and maintain documentation and cleanliness.
3.2 Quality Assurance (QA) is responsible to conduct regular audits, training for SOP, review and approve records.
3.3 Engineering/Maintenance is responsible to ensure proper functioning of HVAC, temperature control, and monitoring systems.
4.0 ACCOUNTABILITY
4.1 Head of Quality Assurance (QA) is accountable for the overall implementation and compliance with this SOP.
5.0 ASSOCIATED DOCUMENTS
5.1 Material Receipt Logbook
5.2 Temperature & Humidity Monitoring Records
5.3 Pest Control Records
5.4 Material Movement Record
5.5 Cleaning Checklist
5.6 FIFO/FEFO Record Sheet
6.0 PRECAUTIONS
6.1 Ensure materials are protected from sunlight, moisture, contamination, and pests.
6.2 Monitor temperature and humidity continuously.
6.3 Segregate quarantine, rejected, and expired materials.
6.4 Maintain cleanliness and orderliness to avoid cross-contamination.
7.0 PROCEDURE
7.1 Material Receipt
7.1.1 Verify supplier documents (CoA, invoice, delivery note).
7.1.2 Check physical condition of consignment.
7.1.3 Label materials as “Under Quarantine” and store in designated quarantine area.
Inform QA for sampling and approval.
7.2 Material Storage
7.2.1 Store approved materials in designated areas (e.g., RM, PM, FG).
7.2.2 Follow FIFO or FEFO system as per product type.
7.2.3 Maintain environmental conditions as per product requirement (e.g., 15–25°C, 60% RH).
7.2.4 Use racks, pallets, and bins to prevent floor contact.
7.2.5 Clearly label storage areas and materials with status tags.
7.3 Controlled Materials Storage
7.3.1 Store narcotics or restricted substances under lock and key.
7.3.2 Maintain a separate register and access log.
7.4 Cold Storage Management
7.4.1 Store temperature-sensitive materials in cold rooms or refrigerators (2–8°C).
7.4.2 Use calibrated temperature monitoring devices with alarms.
7.5 Stock Rotation
7.5.1 Implement FIFO/FEFO to minimize expiry-related waste.
7.5.2 Perform regular stock checks and reconciliations.
7.6 Cleaning & Housekeeping
7.6.1 Follow cleaning schedules for floors, walls, racks, and equipment.
7.6.2 Record cleaning activity in the cleaning log book.
7.7 Pest Control
7.7.1 Conduct routine pest control per schedule.
7.7.2 Maintain records and verify effectiveness.
7.8 Dispatch of Goods
7.8.1 Ensure QA release before dispatch.
7.8.2 Pack and label finished goods securely.
7.8.3 Verify dispatch documentation and vehicle conditions.
7.9 Documentation & Record-Keeping
7.9.1 Maintain all logs, checklists, and records for traceability.
7.9.2 Archive records as per document retention policy.
8.0 ABBREVIATIONS/DEFINITIONS
8.1 GWP: Good Warehousing Practices
8.2 SOP: Standard Operating Procedure
8.3 QA: Quality Assurance
8.4 FIFO: First In First Out
8.5 FEFO: First Expiry First Out
8.6 RM: Raw Material
8.7 PM: Packaging Material
8.8 FG: Finished Goods
8.9 HVAC: Heating, Ventilation, and Air Conditioning
9.0 ANNEXURES
9.1 Annexure I: Warehouse Cleaning Checklist Log Book
Annexure I: Warehouse Cleaning Checklist Log Book
| Date | Time | Area | Activity | Status (✓/✗) | Cleaned By | Checked By | Remarks |
| Floor Area | Sweeping & Mopping | ||||||
| Racks & Shelves | Dusting | ||||||
| Storage Containers | Wiping & Disinfection | ||||||
| Cold Room | Cleaning Walls & Floor | ||||||
| Entry/Exit Points | Cleaning Door Area | ||||||
| General Observation | Pest Activity Signs |
9.2 Annexure II: Temperature Monitoring Log Book
Annexure II: Temperature Monitoring Log Book
Location: ___________________
| Date | Time | Temp (°C) | Humidity (%RH) | Recorded By | Checked By | Remarks |
9.3 Annexure III: Material Receipt & Verification Form
Annexure III: Material Receipt & Verification Form
Date of Receipt: ____________
Supplier Name: _______________
Invoice No.: ________________
| Material Name | Material Code | Batch No. | Qty. Received | Condition | Quarantine Label Applied (Yes/No) | Received By | Remarks |
Checked by (Warehouse In-charge): __________________
Signature: _____________________
Forwarded to QA for Sampling: □ Yes □ No
9.4 Annexure IV: FIFO/FEFO Tracking Sheet
Annexure IV: FIFO/FEFO Tracking Sheet
Material Type: RM / PM / FG
Tracking Method: □ FIFO □ FEFO
| Material Name | Batch No. | Date Received | Expiry Date | Qty. in Stock | Issue Date | Issued Quantity | Issued To | Remarks |
Verified by (Store Supervisor): __________________
Signature: _____________________
9.5 Annexure V: Pest Control Record Sheet
Annexure V: Pest Control Record Sheet
Frequency: Weekly / Monthly
| Date | Location Treated | Pest Control Activity | Service Provider Name | Observations (Dead/Insects Found) | Signed by Technician | Verified by QA | Remarks |
10. REVISION HISTORY
| Version | Date | Description of Change | Reviewed By | Approved By |
| 1.0 |