Standard Operating Procedure for Storage of Raw Materials in Compliance with GMP Guidelines

Department	Warehouse / Quality Assurance
SOP No.	SOP/RM/101/2025
Supersedes	SOP/RM/101/2022
Page No.	Page 1 of 15
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the guidelines for storing raw materials in compliance with Good Manufacturing Practices (GMP). It ensures that materials are stored under appropriate conditions to maintain their quality, integrity, and traceability.

2. Scope

This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other chemicals stored in the warehouse. It covers storage conditions, labeling, segregation, and documentation requirements in accordance with GMP guidelines.

3. Responsibilities

• Warehouse Personnel: Ensure proper storage, labeling, segregation, and documentation of raw materials.
• Quality Assurance (QA): Verify compliance with GMP storage requirements and conduct periodic audits of storage practices.
• Warehouse Manager: Oversee the storage process, ensure proper environmental conditions, and maintain records of material movement.

4. Accountability

The QA Manager is accountable for ensuring that storage practices comply with GMP guidelines. The Warehouse Manager is responsible for maintaining proper storage conditions and accurate records.

5. Procedure

5.1 General Storage Guidelines

1. Receiving and Initial Inspection:
   • Upon receipt, raw materials must be inspected for damage and documented in the Material Receipt Log (Annexure-1).
   • Only materials that pass initial inspection should be moved to the storage area.
2. Segregation of Materials:
   • Segregate materials based on their status: Approved, Quarantined, or Rejected.
   • Store hazardous, flammable, and temperature-sensitive materials in designated areas.
   • Ensure physical separation of incompatible materials to prevent cross-contamination.

5.2 Storage Conditions

1. Temperature and Humidity Control:
   • Store raw materials under controlled temperature and humidity conditions as specified by the manufacturer or regulatory guidelines.
   • Document environmental conditions in the Temperature and Humidity Log (Annexure-2).
2. Controlled Storage for Sensitive Materials:
   • APIs, hygroscopic, and light-sensitive materials should be stored in controlled environments with proper protective measures (e.g., desiccants, UV-protected storage).
   • Maintain a separate log for sensitive material storage (Annexure-3).

5.3 Labeling and Documentation

1. Labeling Requirements:
   • Each container must be labeled with:
     • Material Name
     • Batch Number
     • Manufacturing Date and Expiry Date
     • Status (Approved, Quarantine, Rejected)
     • Storage Conditions (if applicable)
   • Document all labeling activities in the Labeling Log (Annexure-4).
2. Inventory Control:
   • Maintain an up-to-date inventory of all raw materials, including quantities, storage locations, and status.
   • Record inventory updates in the Inventory Control Log (Annexure-5).

5.4 Periodic Review and Compliance Checks

1. Warehouse Inspections:
   • Conduct regular inspections of storage areas to ensure compliance with GMP guidelines.
   • Record inspection findings in the Warehouse Inspection Log (Annexure-6).
2. Corrective Actions:
   • Document and address any deviations from storage protocols.
   • Record corrective actions in the Corrective Action Log (Annexure-7).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

1. Material Receipt Log (Annexure-1)
2. Temperature and Humidity Log (Annexure-2)
3. Sensitive Material Storage Log (Annexure-3)
4. Labeling Log (Annexure-4)
5. Inventory Control Log (Annexure-5)
6. Warehouse Inspection Log (Annexure-6)
7. Corrective Action Log (Annexure-7)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO GMP Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Receipt Log

Date	Material Name	Batch Number	Supplier	Received By
01/02/2025	API-X	API-X-2025-001	Supplier A	Ravi Kumar

Annexure-2: Temperature and Humidity Log

Date	Storage Area	Temperature (°C)	Humidity (%)	Recorded By
01/02/2025	Warehouse A	22°C	45%	Sunita Sharma

Annexure-3: Sensitive Material Storage Log

Date	Material Name	Batch Number	Storage Condition	Monitored By
01/02/2025	Light-Sensitive API	LS-API-2025-002	Stored in UV-Protected Area	Anjali Mehta

Annexure-4: Labeling Log

Date	Material Name	Batch Number	Label Status	Labeled By
01/02/2025	API-X	API-X-2025-001	Quarantine	Ravi Kumar

Annexure-5: Inventory Control Log

Date	Material Name	Batch Number	Quantity	Location	Updated By
01/02/2025	API-X	API-X-2025-001	100 kg	Shelf A1	Sunita Sharma

Annexure-6: Warehouse Inspection Log

Date	Area Inspected	Inspector	Findings	Corrective Actions
02/02/2025	Warehouse A	Anjali Mehta	No issues found	N/A

Annexure-7: Corrective Action Log

Date	Issue Identified	Corrective Action Taken	Actioned By
03/02/2025	Incorrect labeling of Batch API-X-2025-001	Label corrected to reflect proper status	Ravi Kumar

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated Storage Procedures and Documentation Formats	Regulatory Compliance	QA Head