and cleaned according to cGMP requirements.

Regulatory Affairs Team: Ensures that all manufacturing processes comply with applicable local, regional, and international regulatory requirements and facilitates interactions with regulatory agencies.

4. Accountability

The Manufacturing Manager is accountable for ensuring that manufacturing operations comply with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Compliance Planning

1. The QA team will review applicable cGMP guidelines, including FDA, EMA, and other relevant regulatory standards, to ensure that the manufacturing processes meet the required compliance criteria.
2. Develop a compliance plan that includes:
   • Documentation requirements for batch records, validation reports, and quality checks.
   • Equipment calibration and maintenance schedules.
   • Training programs for personnel on cGMP standards and internal procedures.
   • Regular internal audits to assess compliance and identify areas for improvement.
3. The compliance plan should be reviewed annually to ensure that all cGMP standards are up-to-date and in line with regulatory changes.

5.2. Documentation and Record Keeping

1. All manufacturing operations must be fully documented in accordance with cGMP standards. This includes:
   • Batch production records
   • Cleaning logs
   • Equipment calibration and maintenance records
   • Raw material and finished product testing results
   • Employee training records
2. Documents must be signed and dated by authorized personnel and stored securely in a document management system for easy retrieval and review.
3. QA will conduct regular document reviews to ensure that all records are complete, accurate, and compliant with cGMP standards.

5.3. Training and Personnel Requirements

1. All personnel involved in aerosol manufacturing operations must receive cGMP training before performing any tasks. The training should cover:
   • Basic cGMP principles and guidelines
   • Company-specific cGMP policies and procedures
   • Equipment operation and safety procedures
   • Proper documentation practices
   • Handling and reporting deviations and non-conformances
2. QA will ensure that all training records are maintained and updated regularly to reflect the most current cGMP guidelines.
3. Personnel will undergo refresher training annually or as needed when cGMP guidelines are updated.

5.4. Equipment Calibration and Maintenance

1. All equipment used in aerosol manufacturing must be regularly calibrated and maintained to meet cGMP standards. The maintenance schedule should include:
   • Routine calibration of measuring and testing equipment
   • Preventive maintenance of production equipment
   • Cleaning and sanitization of equipment between production runs
2. The Maintenance Team is responsible for scheduling and executing maintenance activities and documenting them in the Equipment Maintenance Log (Annexure-1).
3. Any equipment failures or issues that may affect product quality must be immediately addressed, and the affected batch may need to be discarded or reprocessed.

5.5. In-Process Monitoring and Testing

1. The QC team will monitor and test in-process materials and finished products to ensure that they meet cGMP standards. In-process testing may include:
   • Fill weights
   • Pressure testing
   • Particle size distribution
   • Viscosity and density testing
   • Microbial testing
2. All in-process test results must be documented in the Batch Record and reviewed by the QA team to ensure that they meet product specifications.
3. Any deviations from established specifications must be documented and investigated, with corrective actions implemented as necessary.

5.6. Internal Audits

1. The QA team will conduct regular internal audits of the manufacturing process to ensure ongoing compliance with cGMP standards. Audits should include:
   • Reviewing batch records and documentation for completeness and accuracy.
   • Inspecting equipment and manufacturing areas for cleanliness and suitability.
   • Verifying that personnel are following approved procedures and work instructions.
2. The audit results should be documented in the Internal Audit Log (Annexure-2), and any non-conformances or areas for improvement should be addressed with corrective actions.
3. Management should review audit findings and ensure that corrective actions are implemented promptly.

5.7. Corrective and Preventive Actions (CAPA)

1. If any non-conformances are identified during production, testing, or audits, a Corrective and Preventive Action (CAPA) process should be initiated. The CAPA process includes:
   • Investigating the root cause of the non-conformance
   • Implementing corrective actions to address the issue
   • Implementing preventive actions to prevent recurrence of the same issue
2. The CAPA process should be documented in the CAPA Log (Annexure-3), and the effectiveness of corrective actions should be verified.

6. Abbreviations

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

7. Documents

1. Equipment Maintenance Log (Annexure-1)
2. Internal Audit Log (Annexure-2)
3. CAPA 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: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
FILL-001	06/02/2025	Calibration and cleaning	Rajesh Patel	Equipment is in good condition

Annexure-2: Internal Audit Log

Audit ID	Audit Date	Auditor Name	Findings Summary	Corrective Actions
AUD-001	06/02/2025	Rajesh Patel	No major findings	Ongoing training for new staff

Annexure-3: CAPA Log

Issue ID	Corrective Action	Implementation Date	Responsible Person	Outcome
CAPA-001	Revised training program	10/02/2025	Rajesh Patel	Completed, effectiveness confirmed

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