removing residues and maintaining a contamination-free environment.

2. Scope

This SOP applies to all cleaning personnel and operators involved in the preparation and use of cleaning agents for cleaning and sanitizing manufacturing equipment, utensils, and contact surfaces in aseptic, solution preparation, and dispensing areas of the sterile injectable facility.

3. Responsibilities

• Production Operator: Prepares and uses cleaning agents as per instructions.
• Sanitation Personnel: Executes cleaning activities and records details in logs.
• Quality Control: Tests efficacy of cleaning agents periodically.
• Quality Assurance: Verifies records, approves cleaning agent lists, and audits practices.

4. Accountability

Head of Production and Head of QA are jointly accountable for ensuring proper use of validated cleaning agents as per this SOP and GMP regulations.

5. Procedure

5.1 Approved Cleaning Agents

1. Use only QA-approved cleaning agents listed in the approved Cleaning Agent Master List (Annexure-1).
2. Common cleaning agents:
   • Alkaline cleaner (e.g., 1% sodium hydroxide)
   • Acidic cleaner (e.g., 1% phosphoric acid)
   • Non-ionic detergent (e.g., enzymatic agents)
   • Disinfectants (e.g., 70% IPA, QAC-based)

5.2 Preparation of Cleaning Agents

1. Prepare cleaning agents using purified water or WFI as per instruction sheets/SDS.
2. Preparation must be done in a dedicated area with appropriate PPE.
3. Label solution containers with:
   • Name of cleaning agent
   • Concentration
   • Date/time of preparation
   • Prepared by
   • Expiry date/time (as per stability)
4. Record preparation details in Cleaning Agent Logbook (Annexure-2).

5.3 Rotation of Cleaning Agents

1. Implement rotation policy to prevent microbial resistance buildup.
2. Maintain a rotation schedule approved by QA (Annexure-3).
3. Ensure minimum two different classes of disinfectants rotated weekly or monthly.

5.4 Application Method

1. Apply agents using lint-free cloths, spray bottles, or automated CIP systems depending on surface and equipment.
2. Follow contact time as specified by manufacturer or validation study (e.g., 10 minutes for QAC, 30 seconds for IPA).
3. After contact time, rinse if applicable or allow to air dry.

5.5 Documentation

1. Document each cleaning activity including:
   • Name and concentration of cleaning agent used
   • Equipment cleaned
   • Time and date
   • Performed by and verified by signatures
2. Maintain records in Equipment Cleaning Log (Annexure-4).

5.6 Handling and Storage

1. Store cleaning agents in designated chemical storage areas with temperature control.
2. All containers must be properly closed, labeled, and stored away from raw materials or drug products.

5.7 Disposal

1. Expired or unused cleaning agents must be discarded as per hazardous waste SOPs.
2. Document disposal in Cleaning Agent Disposal Log (Annexure-5).

6. Abbreviations

• SOP: Standard Operating Procedure
• PPE: Personal Protective Equipment
• QA: Quality Assurance
• QC: Quality Control
• IPA: Isopropyl Alcohol
• QAC: Quaternary Ammonium Compound
• WFI: Water for Injection

7. Documents

1. Annexure-1: Cleaning Agent Master List
2. Annexure-2: Cleaning Agent Preparation Log
3. Annexure-3: Cleaning Agent Rotation Schedule
4. Annexure-4: Equipment Cleaning Log
5. Annexure-5: Cleaning Agent Disposal Log

8. References

• ICH Q7 Good Manufacturing Practice Guidelines
• EU GMP Annex 1: Manufacture of Sterile Medicinal Products
• WHO TRS 961
• 21 CFR Part 211

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Sanitation Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Cleaning Agent Master List

Cleaning Agent	Type	Concentration	Approved By
IPA	Disinfectant	70%	Sunita Reddy
QAC	Disinfectant	1%	Sunita Reddy
Sodium Hydroxide	Alkaline Cleaner	1%	Sunita Reddy

Annexure-2: Cleaning Agent Preparation Log

Date	Agent	Concentration	Prepared By	Expiry
22/06/2025	QAC	1%	Ravi Joshi	23/06/2025

Annexure-3: Cleaning Agent Rotation Schedule

Week	Primary Agent	Alternate Agent	Verified By
Week 1	QAC	IPA	QA
Week 2	IPA	QAC	QA

Annexure-4: Equipment Cleaning Log

Date	Equipment ID	Agent Used	Cleaned By	Checked By
22/06/2025	VL-05	IPA	Suresh Kumar	QA

Annexure-5: Cleaning Agent Disposal Log

Date	Agent	Quantity	Disposed By	Witnessed By
22/06/2025	QAC	2 Litres	Anita Sharma	QA

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
24/06/2025	2.0	Updated rotation policy and annexures	Annual Review	QA Head