Manager is accountable for ensuring proper lighting in all storage areas, while the Maintenance Manager is responsible for maintaining the lighting infrastructure. The QA Manager ensures compliance through regular audits.

5. Procedure

5.1 Lighting Standards and Requirements

1. General Lighting Requirements:
   • Ensure lighting levels meet the minimum standards of 200 lux for general storage areas and 300 lux for inspection zones.
   • Install shatterproof light covers to prevent contamination from broken bulbs.
   • Use energy-efficient LED lighting where applicable to reduce heat emissions.
2. Special Requirements for Light-Sensitive Materials:
   • Store light-sensitive materials under UV-protected lighting or in designated dark storage areas.
   • Document the storage of light-sensitive materials in the Light-Sensitive Material Log (Annexure-1).

5.2 Monitoring and Inspection of Lighting

1. Daily Visual Inspection:
   • Warehouse personnel must perform daily visual checks to ensure all lights are operational.
   • Record findings in the Daily Lighting Inspection Log (Annexure-2).
2. Monthly Maintenance Check:
   • The maintenance team shall conduct a detailed inspection of all lighting systems monthly.
   • Ensure all light fittings are secure and free from dust or obstructions.
   • Document inspections in the Monthly Lighting Maintenance Log (Annexure-3).

5.3 Handling and Reporting Lighting Deficiencies

1. Reporting Procedure:
   • Any faulty lighting must be reported immediately using the Lighting Deficiency Report (Annexure-4).
   • The maintenance team must address the issue within 24 hours of reporting.
2. Corrective Actions:
   • Document corrective actions taken in the Lighting Corrective Action Log (Annexure-5).
   • QA must verify the resolution of lighting issues and sign off on the report.

5.4 Preventive Maintenance

1. Scheduled Preventive Maintenance:
   • The maintenance team will conduct preventive maintenance of lighting fixtures quarterly.
   • Replace aging bulbs, clean light fixtures, and ensure backup lighting systems are operational.
   • Document preventive maintenance in the Preventive Maintenance Log (Annexure-6).
2. Emergency Lighting Systems:
   • Test emergency lighting systems monthly to ensure functionality during power outages.
   • Record emergency lighting checks in the Emergency Lighting Test Log (Annexure-7).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• LED: Light Emitting Diode

7. Documents

1. Light-Sensitive Material Log (Annexure-1)
2. Daily Lighting Inspection Log (Annexure-2)
3. Monthly Lighting Maintenance Log (Annexure-3)
4. Lighting Deficiency Report (Annexure-4)
5. Lighting Corrective Action Log (Annexure-5)
6. Preventive Maintenance Log (Annexure-6)
7. Emergency Lighting Test Log (Annexure-7)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
• Occupational Safety and Health Administration (OSHA) Lighting Standards

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Light-Sensitive Material Log

Date	Material Name	Batch Number	Storage Condition	Stored By
21/03/2025	Vitamin C	VC-1234	UV-Protected Cabinet	Ravi Kumar
21/03/2025	Riboflavin	RB-5678	Dark Storage Area	Neha Verma

Annexure-2: Daily Lighting Inspection Log

Date	Storage Area	Inspection Status	Remarks	Inspected By
21/03/2025	Warehouse A1	All lights operational	—	Priya Singh
21/03/2025	Hazardous Storage Area	One light flickering	Reported to Maintenance	Amit Joshi

Annexure-3: Monthly Lighting Maintenance Log

Date	Area	Maintenance Performed	Maintained By	Verified By
21/03/2025	Warehouse A2	Replaced 2 faulty LED lights	Ravi Kumar	Neha Verma
21/03/2025	Cold Storage Area	Cleaned fixtures, all lights functional	Amit Joshi	Priya Singh

Annexure-4: Lighting Deficiency Report

Date	Storage Area	Deficiency Identified	Reported By	Action Taken
21/03/2025	Hazardous Storage Area	Light flickering near entry	Amit Joshi	Pending
21/03/2025	Warehouse B1	Dim lighting in back corner	Ravi Kumar	Bulb replacement scheduled

Annexure-5: Lighting Corrective Action Log

Date	Deficiency	Corrective Action Taken	Corrected By	Verified By
21/03/2025	Flickering light in Hazardous Storage	Replaced with new LED light	Ravi Kumar	Neha Verma
21/03/2025	Dim lighting in Warehouse B1	Installed brighter LED bulb	Amit Joshi	Priya Singh

Annexure-6: Preventive Maintenance Log

Date	Area	Maintenance Activity	Performed By
21/03/2025	General Storage Area	Cleaned all light covers	Ravi Kumar
21/03/2025	Cold Storage	Checked backup lighting systems	Amit Joshi

Annexure-7: Emergency Lighting Test Log

Date	Test Area	Status of Emergency Lights	Tested By	Remarks
21/03/2025	Warehouse Exit A	Functional	Priya Singh	—
21/03/2025	Cold Storage Emergency Exit	Non-functional	Neha Verma	Reported for repair

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
21/03/2025	2.0	Included preventive maintenance protocols	To align with updated GMP and OSHA guidelines	QA Head