are used in compliance with this SOP.

Quality Control (QC) Team: Verifies that all cleaning processes involving cleaning agents are compliant with safety and environmental standards. They are also responsible for confirming that no cleaning agents remain on the equipment after cleaning.

Health and Safety Officer: Ensures that all personnel involved in cleaning activities are properly trained on the safe handling, storage, and disposal of cleaning agents and are provided with necessary Personal Protective Equipment (PPE).

Waste Management Team: Responsible for ensuring that all cleaning agents are disposed of according to environmental and safety regulations.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed, including the safe handling and proper disposal of cleaning agents. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Handling of Cleaning Agents

1. Before using cleaning agents, review the Material Safety Data Sheets (MSDS) for each chemical to understand potential hazards, safety precautions, and recommended handling procedures.
2. Ensure that all operators handling cleaning agents are trained in the proper handling procedures, including the use of appropriate PPE such as gloves, goggles, and aprons.
3. When transferring cleaning agents, ensure they are stored in their original containers with clear labeling indicating the chemical’s name, hazards, and handling instructions.
4. Store cleaning agents in a well-ventilated area, away from direct sunlight and sources of heat. Ensure that the storage area is cool, dry, and secure to prevent accidental spills or contamination.
5. Ensure that any dispensing equipment used for cleaning agents is properly maintained and cleaned to prevent cross-contamination between different agents.

5.2. Disposal of Cleaning Agents

1. After cleaning operations are completed, dispose of used cleaning agents according to the following guidelines:
   • If the cleaning agent is water-based and non-hazardous, it may be disposed of through the regular wastewater disposal system, provided it meets the company’s discharge limits and regulatory guidelines.
   • If the cleaning agent is flammable or contains hazardous chemicals, dispose of it according to hazardous waste management procedures. Ensure that waste disposal complies with local, state, and federal regulations.
   • For cleaning agents that have not been used, return the remaining product to its original container and store it properly until the next use.
2. Ensure that all waste containers used for cleaning agents are labeled appropriately to identify the contents and ensure safe disposal.
3. Use appropriate spill containment measures, such as absorbent pads or containment booms, in case of accidental leaks or spills during the disposal process.
4. Work with the Waste Management Team to ensure that cleaning agent disposal complies with environmental protection regulations and that waste is handled, stored, and disposed of properly.

5.3. Emergency Procedures

1. In case of accidental exposure to cleaning agents, follow the emergency procedures outlined in the MSDS for the specific agent involved. This may include rinsing the affected area with water, seeking medical attention, or using an eyewash station.
2. If a spill occurs, immediately contain the spill by using appropriate absorbent materials and follow the company’s spill response procedures. Report the spill to the Health and Safety Officer for further action and documentation.
3. Ensure that emergency eyewash stations and safety showers are available and easily accessible in areas where cleaning agents are handled.

5.4. Safety and Environmental Considerations

1. Ensure that all personnel involved in cleaning agent handling are trained on the potential hazards and the proper use of PPE, including gloves, goggles, and respiratory protection if required.
2. Ensure proper ventilation in areas where cleaning agents are used to prevent the buildup of fumes or vapors that could pose a health risk to personnel.
3. Ensure that cleaning agents are not discharged into the environment, including drains, stormwater systems, or open areas, unless they are approved for safe discharge according to environmental regulations.
4. Ensure that all cleaning activities are conducted in compliance with environmental protection laws and regulations, particularly in relation to the disposal of hazardous cleaning agents.

5.5. Documentation and Record-Keeping

1. Document all cleaning agent usage, including the type and quantity of cleaning agents used, the areas cleaned, and the disposal method in the Cleaning Agent Usage Log (Annexure-1).
2. Maintain records of cleaning agent handling, including safety training, emergency procedures, and disposal activities, as per the company’s document retention policy.
3. Ensure that all records are accurate, complete, and available for review during audits or regulatory inspections.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure
• MSDS: Material Safety Data Sheet

7. Documents

1. Cleaning Agent Usage Log (Annexure-1)
2. Emergency Spill Response Log (Annexure-2)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems
• Occupational Safety and Health Administration (OSHA) Regulations

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Agent Usage Log

Cleaning Agent	Quantity Used	Operator Name	Machine ID	Date
Solvent A	5 Liters	Rajesh Patel	F-12345	06/02/2025

Annexure-2: Emergency Spill Response Log

Spill Location	Spill Size	Response Action	Operator Name	Date
Filling Area	Small	Contained, cleaned, and disposed of	Rajesh Patel	06/02/2025

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated procedures for handling and disposal of cleaning agents	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures