SOP for QA Oversight During Manufacturing Operations

Department	Aerosol
SOP No.	SOP/Aerosol/088/2025
Supersedes	SOP/Aerosol/088/2022
Page No.	Page 1 of Y
Issue Date	06/02/2025
Effective Date	16/02/2025
Review Date	06/02/2028

1. Purpose

This Standard Operating Procedure (SOP) outlines the responsibilities of Quality Assurance (QA) during aerosol manufacturing operations. The objective is to ensure that the manufacturing process is carried out in compliance with GMP regulations and that the quality of the finished aerosol products meets company standards and regulatory requirements. QA oversight helps identify and mitigate risks during production, ensuring the safety, efficacy, and quality of the product.

2. Scope

This SOP applies to all aerosol manufacturing operations at [Company Name]. It covers the role of QA in monitoring production activities, reviewing records, conducting inspections, and ensuring that all processes comply with quality standards and regulatory requirements.

3. Responsibilities

• QA Team: Responsible for overseeing manufacturing operations, ensuring compliance with GMP guidelines, conducting in-process inspections, reviewing batch records, and approving or rejecting finished products based on quality standards.
• Production Team: Responsible for executing manufacturing processes according to approved procedures, documenting production activities, and reporting any deviations or non-conformances to the QA team.
• Maintenance Team: Ensures that all equipment used in manufacturing is properly maintained and calibrated, and that it operates within specified parameters.
• Regulatory Affairs Team: Ensures that manufacturing operations meet all relevant regulatory requirements and that any necessary reporting or compliance activities are completed.

4. Accountability

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

5. Procedure

5.1. QA Oversight Planning

1. Before production begins, the QA team will review the production schedule, batch records, and relevant documentation to ensure that all required materials, equipment, and processes are in place.
2. QA will ensure that personnel involved in the manufacturing process are trained in GMP and the specific procedures for the batch being produced.
3. QA will confirm that all equipment used in the manufacturing process is calibrated and maintained according to established procedures.
4. The QA team will ensure that appropriate in-process tests and inspections are scheduled throughout the manufacturing process.

5.2. Monitoring Production Activities

1. During the manufacturing process, the QA team will conduct periodic inspections of the production areas, including:
   • Inspecting equipment and manufacturing areas for cleanliness and suitability.
   • Monitoring in-process testing (e.g., fill weights, pressure testing, particle size analysis) to ensure that product specifications are being met.
   • Ensuring that production personnel are following approved procedures and work instructions.
2. QA will document all inspections and observations, noting any discrepancies or non-compliance issues. If any deviations are found, they must be reported to the production team immediately.
3. Any non-conformance issues observed during the inspection should be addressed promptly by the production team, and corrective actions should be documented in the Deviation Log (Annexure-1).

5.3. Review of Batch Records

1. After each production batch is completed, the QA team will review the batch records to ensure that all required documentation is complete and accurate. The batch records should include:
   • Raw material usage
   • Process parameters (e.g., temperature, pressure, speed)
   • In-process test results
   • Operator and supervisory signatures
   • Any deviations or non-conformances and associated corrective actions
2. QA will ensure that all batch records are complete and that any deviations have been properly investigated and resolved before the batch is released for packaging.
3. If the batch records are incomplete or inaccurate, QA will request additional information or clarification before approving the batch.

5.4. Product Release

1. Before a finished batch is released for packaging, the QA team will conduct a final review of the batch records, in-process test results, and cleaning validation data (if applicable).
2. If all quality standards have been met and no issues remain, the QA team will approve the batch for release to packaging.
3. If any discrepancies or issues are identified during the final review, the batch will not be approved until corrective actions have been taken. The QA team will document these issues in the Non-Conformance Log (Annexure-2).

5.5. Reporting and Documentation

1. The QA team will maintain comprehensive records of all oversight activities, including in-process inspections, batch record reviews, and product approvals.
2. All reports and documentation related to QA oversight must be stored in the document management system for easy access and future reference.
3. QA will provide regular reports to management on the status of manufacturing operations, including any issues or concerns related to product quality and regulatory compliance.

5.6. Corrective and Preventive Actions

1. If any deviations or non-compliance issues are identified during QA oversight, corrective actions must be implemented immediately. Corrective actions may include:
   • Investigating the root cause of the deviation.
   • Implementing changes to manufacturing procedures or equipment.
   • Providing retraining for personnel.
2. Preventive actions should also be considered to prevent recurrence of the same issue. These may include process improvements, additional testing, or enhanced monitoring procedures.
3. All corrective and preventive actions must be documented in the Corrective Action Log (Annexure-3), including the person responsible, due date, and status of the action.

6. Abbreviations

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

7. Documents

1. Deviation Log (Annexure-1)
2. Non-Conformance Log (Annexure-2)
3. Corrective Action 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: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Operator Name	Approval
DEV-12345	Underfill detected	Adjusted filling machine settings	Rajesh Patel	Approved

Annexure-2: Non-Conformance Log

Non-Conformance ID	Non-Conformance Description	Corrective Action	Responsible Person	Status
NC-001	Improper temperature during filling	Re-calibrated temperature control	Rajesh Patel	Completed

Annexure-3: Corrective Action Log

Deviation ID	Corrective Action	Implementation Date	Responsible Person	Status
DEV-12345	Re-calibrated filling machine	07/02/2025	Rajesh Patel	Completed

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