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Bioburg Warehouse, including design, regulatory compliance, and operational best practices. This content is ideal for documentation, investor decks, facility planning, or pharma company presentations:
A Pharmaceutical Warehouse is a critical infrastructure component in the pharma supply chain where medicines, raw materials, packaging items, and medical devices are stored under controlled conditions. The warehouse must meet regulatory, safety, and quality compliance to ensure product integrity from manufacturing to the end-user.
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Objective |
Description |
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Storage |
Safekeeping of finished goods, raw materials, excipients, and packaging |
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Distribution |
Supplying products to distributors, franchisees, hospitals, and retailers |
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Compliance |
Ensuring all products are stored under recommended temperature/humidity |
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Inventory Management |
Real-time tracking of batches, expiry, and stock rotation |
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Traceability |
Maintaining audit trails and batch-wise traceability for recalls or audits |
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Area |
Function |
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Receiving Area |
For raw material/incoming goods inspection |
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Quarantine Area |
Hold materials until quality clearance |
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Approved Material Area |
Segregated area for cleared stock |
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Rejected Material Area |
Dedicated zone for non-conforming or expired stock |
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Finished Goods Store |
Temperature-controlled storage for market-ready products |
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Cold Storage |
2–8°C zone for heat-sensitive products |
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Dispensing Area |
For weighing, sampling, and transferring materials for production |
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Dispatch Area |
For packaging, invoicing, and logistics handover |
✅ The warehouse design should ensure unidirectional flow to avoid cross-contamination and mix-ups.
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Parameter |
Ideal Range |
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Temperature |
15–25°C (unless otherwise specified) |
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Cold Chain |
2–8°C (for insulin, vaccines, etc.) |
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Humidity |
35–65% RH |
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Monitoring |
24/7 digital logging and alert systems |
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Power Backup |
UPS & diesel generators for cold storage protection |
🧊 Thermohygrometers, data loggers, and HVAC systems are mandatory for maintaining pharmaceutical-grade conditions.
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Authority |
Key Requirements |
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CDSCO (India) |
Good Storage Practices (GSP), Schedule M |
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WHO-GMP |
Annex 9: GSP and Supply Chain Integrity |
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USFDA |
21 CFR Part 211 – cGMP for Storage |
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NABCB/NABL |
For cold chain verification labs |
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State Drug Licensing |
Mandatory for wholesale operations |
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Area |
Practice |
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Inventory |
FIFO (First In First Out) / FEFO (First Expiry First Out) |
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Documentation |
Batch records, GRNs, dispatch logs, cleaning records |
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Security |
CCTV, access control, physical security |
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Sanitation |
Pest control, cleaning SOPs, no food/drink zones |
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Traceability |
Barcode/RFID-enabled stock tracking |
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Training |
Staff trained in SOPs, hygiene, fire safety |
|
Tool |
Function |
|
WMS (Warehouse Management System) |
Real-time stock monitoring and control |
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ERP Integration |
End-to-end traceability with production and dispatch |
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e-BMR/e-BPR Integration |
Electronic batch/production records for quality audits |
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Cloud Backup |
For audit-proof data archiving |
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Temperature Mapping Software |
Validates uniform temperature across zones |
|
License |
Purpose |
|
Wholesale Drug License (Form 20B/21B) |
For stocking and selling pharma goods |
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Storage Approval |
By Drug Inspector and Pollution Control Board |
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Cold Chain Certificate |
For thermolabile products |
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NABL Calibration Reports |
For thermometers, freezers, etc. |
Bioburg operates with state-of-the-art pharma-compliant warehouses, including:
Our warehouses support our in-house products, third-party manufacturing clients, and pharma franchise distributors.
|
Feature |
Detail |
|
Role |
Ensures product integrity, traceability, and compliance |
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Environmental Control |
Temperature, humidity, cold chain |
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Licensing |
CDSCO, GSP, Drug Control Approval |
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Tools |
WMS, ERP, digital logs, SOPs |
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Bioburg’s Focus |
Safe, scalable, GDP-compliant warehousing |