are followed, including the correct use of personal protective equipment (PPE) and maintaining the integrity of the clean room environment.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed during the operation of manufacturing equipment in clean rooms. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation for Equipment Operation

1. Ensure that all equipment is clean, calibrated, and ready for use. Equipment should be checked for any signs of wear, contamination, or malfunction before entering the clean room.
2. Ensure that the clean room environment meets the required cleanliness levels (e.g., temperature, humidity, particulate control) before starting the operation. Conduct a quick inspection for any contamination risks.
3. Verify that the required PPE is available for operators, including gloves, gowns, face masks, and other protective gear necessary to maintain the integrity of the clean room environment.
4. Verify that all necessary materials and ingredients are prepared and ready for the manufacturing process.

5.2. Operating Manufacturing Equipment

1. Before starting the equipment, verify that it is properly calibrated according to the specifications of the formulation or product being produced.
2. Operate the equipment as instructed in the equipment’s user manual or standard operating procedures. This includes adjusting settings for speed, temperature, pressure, or any other critical parameters required for the process.
3. During operation, continuously monitor the equipment’s performance, ensuring it is functioning within the defined parameters. Make adjustments as needed to maintain the required process conditions.
4. Ensure that the equipment is not overloaded or misused during operation, as this could compromise product quality or the cleanliness of the manufacturing environment.
5. Record all equipment settings, operational parameters, and observations in the Equipment Operation Log (Annexure-1). This log should include information such as start time, operator details, adjustments made, and any deviations from standard operating conditions.

5.3. In-Process Monitoring and Quality Checks

1. During the operation of the equipment, perform regular in-process checks to ensure that the product quality remains within specifications. These checks may include:
   • Monitoring temperature, pressure, and humidity (if applicable)
   • Checking for any signs of contamination in the product or equipment
   • Sampling the product for consistency and quality tests
2. If any deviations from the set parameters are observed, stop the operation and investigate the cause. Adjust the equipment settings as necessary to correct the issue and ensure that the product meets all quality standards.
3. Document all quality checks, including test results, corrective actions, and any deviations in the In-Process Testing Log (Annexure-2).

5.4. Post-Operation Procedure

1. Once the manufacturing process is complete, properly shut down the equipment and clean it as per the cleaning procedures specified for that particular equipment. Ensure that no residual product is left inside the equipment to prevent cross-contamination.
2. Inspect the equipment for any damage, contamination, or wear that may require maintenance or repair. If any issues are found, report them to the maintenance team for further action.
3. Ensure that all records, including operation logs and quality check results, are completed and stored in accordance with the company’s document retention policy.
4. Transfer the product to the next phase of manufacturing or packaging, ensuring it is properly stored and maintained in accordance with quality control standards.

5.5. Safety and Environmental Considerations

1. Ensure that the clean room is maintained according to safety standards, including proper air filtration, temperature, and humidity controls, to prevent contamination of the product.
2. Ensure that all operators are wearing the appropriate PPE, including gloves, gowns, masks, and face shields, to maintain the cleanliness of the clean room.
3. Ensure that all safety protocols are followed during equipment operation, including proper handling of flammable or hazardous materials and emergency procedures in case of accidents or spills.
4. Ensure that any waste generated during the manufacturing process is properly disposed of in accordance with the company’s environmental safety protocols.

5.6. Documentation and Record-Keeping

1. Complete the Equipment Operation Log (Annexure-1) with all necessary details, including equipment settings, operational parameters, and any deviations or corrective actions.
2. Document all in-process checks, quality checks, and any deviations from the standard procedure in the In-Process Testing Log (Annexure-2).
3. Store all records according to the company’s document retention policy and ensure they are available for review during audits or inspections.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions
• PPE: Personal Protective Equipment
• R&D: Research and Development

7. Documents

1. Equipment Operation Log (Annexure-1)
2. In-Process Testing 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
• International Pharmacopoeia (Ph. Int.) – Aerosol Delivery

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Operation Log

Batch No.	Equipment Used	Operator Name	Settings	Duration	Comments
12345	High-Shear Mixer	Rajesh Patel	Speed: 1000 rpm	30 mins	No issues

Annexure-2: In-Process Testing Log

Test Parameter	Test Result	Test Date	Tested By
Viscosity	Pass	06/02/2025	Rajesh Patel

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 equipment operation procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures