SOP Guide for Pharma

Aerosol: SOP for QA Oversight During Manufacturing Operations – V 2.0

Auditor

Aerosol: SOP for QA Oversight During Manufacturing Operations – V 2.0

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

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.

See also  Aerosol: SOP for Conducting Internal Audits in Aerosol Manufacturing - V 2.0

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.
See also  Aerosol: SOP for Conducting Risk Assessment During Product Development - V 2.0

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.
See also  Aerosol: SOP for Cleaning Aerosol Filling Machines - V 2.0

6. Abbreviations

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:

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
Exit mobile version