and compliance with GMP and sustainability goals.

Engineering Department: Support implementation of energy-efficient equipment and systems.

4. Accountability

The Head – Manufacturing shall be accountable for ensuring the continuous improvement of sustainable practices in gel manufacturing operations and for compliance with applicable environmental regulations.

5. Procedure

5.1 Energy Management

1. Install energy-efficient lighting (e.g., LED) and automate lighting systems using motion sensors.
2. Use variable frequency drives (VFDs) on motors and pumps to reduce electricity consumption.
3. Monitor power consumption daily and compare against benchmark targets.
4. Shut down idle equipment during non-production hours.
5. Conduct periodic energy audits to identify areas of improvement.

5.2 Water Conservation

1. Use flow restrictors and low-flow valves in water outlets.
2. Recycle and reuse purified water for non-critical cleaning processes wherever feasible.
3. Install sensors or timers on cleaning equipment to control water usage.
4. Capture rainwater through harvesting systems for facility maintenance use.

5.3 Waste Reduction and Segregation

1. Implement source segregation of hazardous, non-hazardous, recyclable, and biomedical waste.
2. Use color-coded bins for each waste type in all gel manufacturing areas.
3. Establish partnerships with authorized recyclers for packaging material reuse.
4. Minimize overproduction and rework through lean manufacturing practices.

5.4 Raw Material Efficiency

1. Adopt just-in-time (JIT) inventory practices to reduce expired or unused raw materials.
2. Use environmentally friendly excipients, preservatives, and APIs where possible.
3. Implement first-expiry-first-out (FEFO) for material utilization.

5.5 Green Chemistry Adoption

1. Identify and substitute hazardous solvents with green alternatives (e.g., ethanol in place of methanol).
2. Conduct risk assessments and toxicological profiling of all gel ingredients during R&D stage.
3. Encourage use of biodegradable gelling agents like carbomers and natural polymers.

5.6 Emission and Pollution Control

1. Install air pollution control devices like scrubbers and HEPA filters on exhaust systems.
2. Monitor VOC levels in manufacturing areas and ensure they remain within permissible limits.
3. Ensure zero liquid discharge (ZLD) policy is followed in effluent treatment plants (ETP).

5.7 Training and Awareness

1. Conduct quarterly training programs for staff on sustainability topics.
2. Display posters and infographics in production areas promoting green practices.
3. Include environmental KPIs as part of individual performance reviews.

5.8 Compliance and Continuous Improvement

1. Track and report monthly environmental performance indicators (EPIs).
2. Conduct internal sustainability audits bi-annually.
3. Review SOP annually and update based on new technologies or regulatory updates.

6. Abbreviations

• SOP: Standard Operating Procedure
• EHS: Environment, Health, and Safety
• VFD: Variable Frequency Drive
• VOC: Volatile Organic Compounds
• ETP: Effluent Treatment Plant
• ZLD: Zero Liquid Discharge
• KPI: Key Performance Indicator

7. Documents

1. Energy Audit Report – Annexure-1
2. Monthly Environmental KPI Sheet – Annexure-2
3. Raw Material Sustainability Checklist – Annexure-3
4. Green Chemistry Evaluation Form – Annexure-4
5. Training Attendance Record – Annexure-5

8. References

• WHO Guidelines on Good Manufacturing Practices (GMP) for Pharmaceutical Products
• UN Sustainable Development Goals (SDGs)
• Central Pollution Control Board (CPCB) India – Environmental Norms

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Production Officer	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Energy Audit Report

Area	Consumption (kWh)	Reduction Opportunity

Annexure-2: Monthly Environmental KPI Sheet

Parameter	Target	Achieved	Remarks

Annexure-3: Raw Material Sustainability Checklist

Material Name	Biodegradable	Hazardous	Action Plan

Annexure-4: Green Chemistry Evaluation Form

Chemical	Alternative	Score	Feasibility

Annexure-5: Training Attendance Record

Name	Employee ID	Date	Topic	Trainer

Revision History

Revision Date	Revision No.	Description of Change	Reason	Approved By
01/03/2022	1.0	Initial version	New SOP	QA Head
09/06/2025	2.0	Added green chemistry and energy audit sections	Process Optimization	QA Head