Standard Operating Procedure for Auditing Third-Party Manufacturers of Tablets

Department	Tablet
SOP No.	SOP/TAB/214/2025
Supersedes	SOP/TAB/214/2022
Page No.	Page 1 of 7
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

This SOP provides the procedure for auditing third-party manufacturers of tablets to ensure compliance with GMP, regulatory guidelines, and company quality standards. It aims to assess manufacturing practices, quality control procedures, and documentation practices to ensure tablet products are safe, effective, and manufactured to required specifications.

2. Scope

This SOP applies to all third-party tablet manufacturers used by the company. It includes the auditing process for assessing manufacturing facilities, equipment, quality systems, and production practices, as well as evaluating compliance with regulatory requirements.

3. Responsibilities

• Quality Assurance (QA) Manager: Responsible for overseeing the audit process, ensuring compliance, and reviewing audit reports.
• Auditing Team: Responsible for conducting the audit, reviewing manufacturing and quality control procedures, and reporting findings.
• Regulatory Affairs Team: Ensures that all auditing practices align with FDA, EMA, and other regulatory guidelines.
• Procurement Team: Responsible for coordinating with third-party manufacturers to schedule audits and ensure timely completion of audit processes.

4. Accountability

The QA Manager is accountable for the entire auditing process, from planning and conducting the audit to reviewing and finalizing the audit reports. The Auditing Team is responsible for carrying out the audit and documenting the findings, while the Procurement Team coordinates with third-party manufacturers.

5. Procedure

5.1 Audit Planning

1. Identify the third-party manufacturer to be audited based on a schedule or in response to a need (e.g., new supplier, product line change, recurring audit requirement).
2. Determine the scope of the audit, which includes evaluating production facilities, manufacturing processes, equipment, and quality control measures (Annexure-1).
3. Coordinate with the third-party manufacturer to schedule the audit and ensure availability of relevant personnel and documents.
4. Prepare an audit checklist that includes key areas of focus, such as compliance with GMP, regulatory adherence, and quality control processes (Annexure-2).

5.2 Conducting the Audit

1. Perform the audit according to the prepared checklist, covering areas such as:
   • Manufacturing environment (cleanliness, safety, and organization).
   • Production and equipment maintenance records.
   • Quality control practices, including raw material testing, in-process testing, and final product testing.
   • Compliance with regulatory requirements (FDA, EMA, etc.).
   • Documentation practices (batch records, deviation reports, CAPA records).
2. Interview key personnel involved in manufacturing and quality control to assess their knowledge and compliance with established procedures.
3. Examine records related to manufacturing, quality control, and validation (Annexure-3).

5.3 Identifying Non-Conformances

1. During the audit, identify any non-conformances or gaps in compliance, including:
   • Failure to adhere to established procedures
   • Deficiencies in equipment calibration and maintenance
   • Inadequate training records or lack of qualified personnel
   • Out-of-specification results or failure to follow proper deviation handling procedures
2. Document each non-conformance, including a description, impact assessment, and proposed corrective actions (Annexure-4).

5.4 Reporting and Review

1. Prepare an audit report that includes findings, non-conformances, and corrective actions, if necessary (Annexure-5).
2. Review the audit report with the QA Manager and relevant teams to determine whether the third-party manufacturer is compliant or requires corrective actions.
3. Share the audit report with the third-party manufacturer, outlining findings and requesting corrective actions for non-conformances (Annexure-6).

5.5 Corrective Actions and Follow-Up

1. If non-conformances are identified, the third-party manufacturer must provide a corrective action plan (CAPA) to address the issues (Annexure-7).
2. Review and approve the corrective action plan, ensuring that it adequately addresses the root causes of the deviations.
3. Conduct a follow-up audit to verify that corrective actions have been implemented and are effective.
4. Document the follow-up audit findings and report to the appropriate teams (Annexure-8).

5.6 Documentation and Record Keeping

1. Ensure that all audit documents, including checklists, reports, and corrective action plans, are properly documented and stored for future reference (Annexure-9).
2. Maintain records for a minimum of 5 years or as required by regulatory guidelines for auditing third-party manufacturers.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• CAPA: Corrective and Preventive Action
• FDA: Food and Drug Administration

7. Documents

1. Audit Checklist (Annexure-2)
2. Audit Report (Annexure-5)
3. Non-Conformance Log (Annexure-4)
4. Corrective Action Plan (Annexure-7)
5. Follow-up Audit Report (Annexure-8)
6. Third-Party Manufacturer Audit Records (Annexure-9)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• GMP Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Audit Planning Template

Area of Focus	Criteria	Responsible Team
Manufacturing Facility	Compliance with GMP	Auditing Team

Annexure-2: Audit Checklist

Area	Criteria	Status	Comments
Production Environment	Cleanliness, safety	Pass	Well-maintained

Annexure-3: Audit Findings Report

Audit Finding	Severity	Action Required	Due Date
Lack of training records	High	Provide training records	03/04/2026

Annexure-4: Non-Conformance Log

Non-Conformance ID	Issue	Impact	Corrective Action
NC-001	Missing calibration records	Possible equipment malfunction	Complete calibration records

Annexure-5: Corrective Action Plan

Action ID	Action Description	Responsible Person	Completion Date
CAP-001	Retrain staff on GMP	Training Coordinator	01/04/2026

Annexure-6: Follow-up Audit Report

Audit Finding	Resolution	Follow-up Action
Lack of training records	Training records completed	Monitor training compliance

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated audit procedures	Clarified responsibilities	QA Head