issues during the mixing process.

Health and Safety Officer: Ensures that all safety protocols are followed during the agitation process, particularly in ensuring proper ventilation when working with volatile solvents or active ingredients.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed during the continuous agitation process. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation of Ingredients

1. Ensure that all components of the suspension formulation, including active ingredients, excipients, and solvents, are correctly weighed and ready for mixing.
2. Pre-mix ingredients, if necessary, to ensure that no agglomerates or particles are present before the agitation process begins.
3. Ensure that the ingredients are free of contaminants and that they are compatible with each other. This may involve verifying solubility and particle size distributions, particularly for suspensions.
4. Verify that the suspension formulation temperature is within the specified range for optimal mixing (usually ambient or slightly elevated temperatures).

5.2. Selection of Agitation Equipment

1. Choose the appropriate mixing or agitation equipment based on the formulation’s characteristics and batch size. Commonly used equipment includes:
   • High-shear mixers
   • Magnetic stirrers
   • Rotary drum mixers
   • Continuous in-line mixers
2. Ensure that the agitation equipment is properly cleaned, calibrated, and ready for use. All equipment must meet GMP standards and be capable of providing the necessary agitation speed to maintain uniform suspension.
3. Ensure that all necessary safety measures are in place, such as emergency stop buttons and proper ventilation if working with volatile chemicals.

5.3. Agitation Process

1. Load the suspension ingredients into the agitation equipment. Ensure that the suspension is free of air pockets and that there is no clogging of the mixing equipment.
2. Start the agitation process at a low speed to allow for proper mixing of ingredients. Gradually increase the speed to the required level for optimal particle dispersion and suspension.
3. Maintain continuous agitation for the required period of time, ensuring that the mixture remains homogeneous throughout the process.
4. Monitor the agitation process to ensure that the mixing speed is consistent and that there are no interruptions or variations in the process that may affect the quality of the suspension.
5. Periodically check the suspension for uniformity and consistency. Perform in-process tests, including:
   • Visual inspection for uniformity
   • Particle size analysis
   • Viscosity testing (if applicable)
6. If any irregularities are detected, adjust the agitation speed, time, or equipment settings accordingly to correct the issue.

5.4. In-Process Testing

1. Perform in-process testing to verify that the suspension formulation is homogeneous. The following tests should be conducted:
   • Visual inspection for any phase separation or sedimentation
   • Testing for particle size distribution to ensure uniformity
   • Measuring the viscosity to ensure the suspension is within the required flow characteristics
2. Document all test results in the In-Process Testing Log (Annexure-1). If the suspension fails to meet specifications, stop the process and perform corrective actions.

5.5. Post-Agitation Procedure

1. Once the agitation process is complete, stop the mixing equipment and transfer the suspension to the next stage of production (e.g., filling, packaging).
2. Inspect the suspension for any signs of instability, such as phase separation or improper particle dispersion.
3. If the suspension meets all specifications, document the process in the Batch Record and In-Process Testing Log (Annexure-1).
4. Store the suspension in a safe, controlled environment until it is ready for filling or further testing.

5.6. Safety and Environmental Considerations

1. Ensure that the agitation area is well-ventilated to minimize the risk of inhalation exposure to any volatile chemicals or solvents used in the formulation.
2. Operators should wear appropriate PPE, such as gloves, goggles, and lab coats, to prevent exposure to potentially hazardous chemicals.
3. Ensure that the agitation equipment is regularly cleaned and maintained to prevent contamination and equipment malfunction.
4. Dispose of any waste materials from the agitation process in accordance with company safety and environmental protocols.

5.7. Documentation and Record-Keeping

1. Document all steps in the Agitation Log (Annexure-2), including the formulation details, batch number, operator name, and equipment settings.
2. Record the results of the in-process tests (e.g., particle size analysis, viscosity) in the In-Process Testing Log (Annexure-1).
3. Ensure that all batch records, logs, and documentation are stored according to the company’s document retention policy and 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. Agitation Log (Annexure-2)
2. In-Process Testing Log (Annexure-1)

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: In-Process Testing Log

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

Annexure-2: Agitation Log

Batch No.	Agitation Speed	Operator Name	Duration	Comments
12345	1000 rpm	Rajesh Patel	30 mins	No issues

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