for attending the training sessions, applying the knowledge learned during training, and following the machine operation and safety guidelines.

Quality Control (QC) Team: Responsible for ensuring that operators maintain the required standards for product quality and machine operation during production runs.

Health and Safety Officer: Ensures that all safety protocols are included in the training, particularly related to the safe handling of pressurized equipment and machine components.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that all operators are adequately trained on machine handling. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Initial Training Program

1. New operators must complete a comprehensive training program that includes:
   • Introduction to aerosol manufacturing machines and their components
   • Detailed instructions on machine setup and operation
   • Hands-on practice with machine operation under the supervision of a qualified trainer
   • Training on machine-specific safety features and emergency shutdown procedures
   • Basic troubleshooting techniques and understanding of common machine issues
   • Workplace safety protocols, including PPE usage and emergency procedures
2. The training program should include both theoretical learning (classroom-based) and practical training (hands-on operation of the machines).
3. After the training, operators should pass a written exam and practical evaluation to demonstrate their understanding of machine handling and safety protocols.
4. Record the completion of the initial training program in the Operator Training Log (Annexure-1), including the date of training, trainer’s name, and operator’s performance assessment.

5.2. Refresher Training Program

1. Experienced operators must complete a refresher training program annually or whenever new machinery, updates, or procedures are introduced.
2. The refresher training program should include:
   • Review of machine operation and safety procedures
   • Updates on any changes to machine settings, procedures, or safety protocols
   • Discussion of common machine issues and best practices for troubleshooting
   • Reinforcement of workplace safety protocols and emergency procedures
3. Operators must demonstrate continued competency in machine operation and safety procedures by completing a practical evaluation and a brief written test.
4. Record the completion of the refresher training in the Operator Training Log (Annexure-1), noting any updates or changes covered during the training.

5.3. On-the-Job Training and Mentorship

1. New operators should be paired with an experienced mentor or trainer for on-the-job training.
2. The mentor will provide guidance during production runs, ensure that the operator follows proper machine handling and safety procedures, and offer corrective feedback when necessary.
3. Operators should be encouraged to ask questions and seek clarification from their mentors if they encounter any difficulties or uncertainties during machine operation.
4. Documentation of on-the-job training sessions should be completed in the On-the-Job Training Log (Annexure-2), which includes the mentor’s name, training dates, and any issues addressed during the training.

5.4. Ongoing Training and Skills Development

1. Provide ongoing training opportunities for operators to enhance their skills, including advanced troubleshooting techniques, machine maintenance training, and safety updates.
2. Encourage operators to participate in continuous improvement initiatives, such as process optimization, to enhance their understanding of machine performance and efficiency.
3. Regularly review operator performance and provide additional training or support if performance issues are identified during production runs.
4. Record any ongoing or additional training in the Ongoing Training Log (Annexure-3), which should include details of the training content, date, and the operator’s performance.

5.5. Documentation and Record-Keeping

1. Ensure that all training activities, including initial, refresher, on-the-job, and ongoing training, are accurately documented and stored in the operator’s training record.
2. All training records should be kept in accordance with the company’s document retention policy and be available for internal audits or regulatory inspections.
3. Ensure that all training logs (Annexures-1, 2, and 3) are updated regularly and maintained in an organized manner for easy reference.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Operator Training Log (Annexure-1)
2. On-the-Job Training Log (Annexure-2)
3. Ongoing Training Log (Annexure-3)

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

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Operator Training Log

Operator Name	Training Date	Trainer Name	Training Content	Assessment Result
Rajesh Patel	06/02/2025	Anjali Sharma	Machine Operation and Safety	Pass

Annexure-2: On-the-Job Training Log

Operator Name	Mentor Name	Training Dates	Topics Covered	Remarks
Rajesh Patel	Ajay Kumar	06/02/2025	Machine Setup, Operation	Completed successfully

Annexure-3: Ongoing Training Log

Operator Name	Training Date	Training Content	Trainer Name	Performance
Rajesh Patel	06/02/2025	Advanced Troubleshooting	Anjali Sharma	Pass

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 training content and procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures