Standard Operating Procedure for Routine Checks for Material Integrity in Storage

Department	Warehouse / Quality Assurance
SOP No.	SOP/RM/160/2025
Supersedes	SOP/RM/160/2022
Page No.	Page 1 of 12
Issue Date	29/03/2025
Effective Date	05/04/2025
Review Date	29/03/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for conducting routine checks to ensure the integrity of raw materials stored in the warehouse. These checks are essential to prevent contamination, spoilage, or degradation, thereby maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials stored in the warehouse, including active pharmaceutical ingredients (APIs), excipients, and packaging materials. It covers visual inspections, physical integrity assessments, and documentation procedures.

3. Responsibilities

• Warehouse Personnel: Conduct routine checks for material integrity, report discrepancies, and maintain inspection records.
• Warehouse Supervisor: Oversee inspection schedules, verify inspection results, and implement corrective actions when necessary.
• Quality Assurance (QA): Review inspection records, ensure compliance with GMP, and audit the inspection process.

4. Accountability

The Warehouse Manager is accountable for the proper execution of routine material integrity checks. The QA Manager is responsible for verifying that all inspections comply with regulatory and company standards.

5. Procedure

5.1 Inspection Schedule and Preparation

1. Frequency of Inspections:
   • Routine checks should be conducted on a weekly basis for all raw materials.
   • Critical materials, such as temperature-sensitive or hazardous substances, require daily inspections.
   • Document inspection schedules in the Inspection Schedule Log (Annexure-1).
2. Inspection Preparation:
   • Ensure inspectors have access to Personal Protective Equipment (PPE) as per material handling requirements.
   • Verify that inspection tools (e.g., flashlights, checklists) are available and in good condition.

5.2 Visual and Physical Integrity Checks

1. Visual Inspection:
   • Check for visible signs of damage, such as dents, leaks, rust, or corrosion on packaging.
   • Ensure that labels are intact, legible, and correspond to the correct batch information.
   • Document visual inspection findings in the Visual Inspection Log (Annexure-2).
2. Physical Integrity Assessment:
   • Confirm that seals and closures are intact and free from tampering.
   • For liquid materials, check for signs of phase separation, cloudiness, or sediment.
   • For solid materials, check for clumping, discoloration, or unusual odors.
   • Document physical assessments in the Physical Integrity Log (Annexure-3).

5.3 Handling Non-Conformities

1. Immediate Reporting:
   • Any non-conformity detected during inspection must be reported immediately to the Warehouse Supervisor and QA.
   • Quarantine the affected materials to prevent further use or distribution.
2. Documentation and Corrective Actions:
   • Record non-conformities in the Non-Conformity Report (Annexure-4).
   • Implement corrective actions and document them in the Corrective Action Log (Annexure-5).

5.4 Documentation and Review

1. Record Maintenance:
   • Maintain all inspection records in the warehouse for a minimum of five years.
   • Ensure records are signed and dated by the inspector and verified by the Warehouse Supervisor.
2. QA Review:
   • QA will conduct monthly reviews of inspection records to ensure compliance with SOPs and GMP requirements.
   • Document reviews in the QA Review Log (Annexure-6).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. Inspection Schedule Log (Annexure-1)
2. Visual Inspection Log (Annexure-2)
3. Physical Integrity Log (Annexure-3)
4. Non-Conformity Report (Annexure-4)
5. Corrective Action Log (Annexure-5)
6. QA Review Log (Annexure-6)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Inspection Schedule Log

Date	Material Name	Batch Number	Scheduled Inspection Date	Inspector Name
29/03/2025	Sodium Bicarbonate	SB-1234	01/04/2025	Ravi Kumar
29/03/2025	Isopropyl Alcohol	IPA-5678	01/04/2025	Neha Verma

Annexure-2: Visual Inspection Log

Date	Material Name	Batch Number	Inspection Findings	Inspected By
29/03/2025	Sodium Bicarbonate	SB-1234	No visible damage, label intact	Ravi Kumar
29/03/2025	Isopropyl Alcohol	IPA-5678	Leak detected on cap	Neha Verma

Annexure-3: Physical Integrity Log

Date	Material Name	Batch Number	Physical Integrity Findings	Inspected By
29/03/2025	Sodium Bicarbonate	SB-1234	Seals intact, no contamination detected	Amit Joshi
29/03/2025	Isopropyl Alcohol	IPA-5678	Minor leakage, quarantine recommended	Priya Singh

Annexure-4: Non-Conformity Report

Date	Material Name	Batch Number	Non-Conformity Description	Reported By
29/03/2025	Isopropyl Alcohol	IPA-5678	Leak detected in packaging, potential contamination risk	Neha Verma

Annexure-5: Corrective Action Log

Date	Non-Conformity	Corrective Action Taken	Verified By
29/03/2025	Leak in Isopropyl Alcohol	Quarantined affected batch, replaced packaging	Ravi Kumar

Annexure-6: QA Review Log

Date	Inspector Name	Inspection Period Reviewed	Review Findings	Reviewed By (QA)
29/03/2025	Ravi Kumar	March 2025	All records complete, one non-conformity addressed	QA Manager

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
29/03/2025	2.0	Added Corrective Action Procedures	Enhance Material Integrity Checks	QA Head