WH001: SOP FOR GOOD WAREHOUSE PRACTICES (GWP)

OBJECTIVE:

This SOP shall describe the requirements and procedures to be followed to ensure proper receipt, storage, handling, control, and dispatch of raw materials, packaging materials, intermediates, finished products, and returned goods in compliance with Good Warehouse Practices.

SCOPE:

This SOP shall be applicable to all warehouse areas including:
- - Raw material warehouse
  - Packaging material warehouse
  - Finished goods warehouse
  - Quarantine, approved, rejected, returned, and recalled goods areas

RESPONSIBILITIES:

Warehouse In-Charge shall ensure implementation of this SOP.
Quality Assurance (QA) Department shall review compliance and approve deviations.
Stores Personnel shall follow the procedures described herein.

DEFINATIONS:

Good Warehouse Practices (GWP): Good Warehouse Practices are a set of controlled activities and requirements that ensure materials and products are received, stored, handled, and distributed in a manner that maintains their identity, quality, safety, and traceability throughout the storage and distribution process.
First In First Out (FIFO): First in First Out is a material management system in which materials that are received first into the warehouse shall be issued or used first, irrespective of their expiry date.
First Expiry First Out (FEFO): First Expiry First Out is a material management system in which materials with the earliest expiry date shall be issued or used first, regardless of the date of receipt.

PROCEDURE:

Warehouse Layout and Segregation:

The warehouse shall be designed to allow orderly storage and prevent mix-ups and cross-contamination.
Separate and clearly demarcated areas shall be maintained for:
- Quarantine materials
- Approved materials
- Rejected materials
- Returned / recalled materials
- All areas shall be clearly labeled and access controlled.

Environmental Conditions:

Temperature, humidity, and pressure differential (where applicable) shall be maintained as per material storage requirements.
Environmental conditions shall be monitored and recorded at defined frequencies.
If the warehouse is non-operational, “No Activity” shall be recorded with operator/designee signature.

Receipt of Materials:

All incoming materials shall be received only against approved purchase orders.
Each consignment shall be visually inspected for:
- Container integrity
- Label correctness
- Physical damage
Received materials shall be labeled as “Under Quarantine” until QA approval.

Storage of Materials:

Materials shall be stored on pallets or racks and shall not be kept directly on the floor.
Adequate space shall be maintained between walls, pallets, and ceilings for cleaning and inspection.
Materials shall be stored as per defined temperature and humidity conditions.
FIFO or FEFO shall be strictly followed.

Handling of Materials:

Material handling shall be done carefully to avoid spillage, damage, or contamination.
Only authorized personnel shall handle warehouse materials.
Clean and dedicated handling equipment shall be used.

Status Labeling:

Each material container shall bear a clear and legible status label indicating:
- - Material name
  - Batch/Lot number
  - Status (Quarantine / Approved / Rejected)
Status labels shall be updated immediately after QA disposition.

Issuance of Materials:

Control of Rejected, Returned, and Recalled Materials:

Cleaning and Housekeeping:

Pest Control:

Pest control activities shall be performed as per an approved pest control program.
Chemicals used shall not pose a contamination risk to stored materials.
Records of pest control activities shall be maintained.

Safety and Security:

Documentation and Records:

All warehouse activities shall be documented contemporaneously.
Records shall be legible, traceable, and retained as per document retention policy.

Deviations:

Any deviation from this SOP shall be documented and investigated.
QA shall review and approve all deviations, appropriate CAPA shall be initiated where required.

Training