Tablets: SOP for Auditing Third-Party Manufacturers of Tablets – V 2.0
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 outlines the procedure for auditing third-party manufacturers of tablets to ensure they comply with GMP, regulatory guidelines, and company quality standards. The goal is to assess the manufacturer’s ability to consistently produce safe, effective, and high-quality tablets.
2. Scope
This SOP applies to all third-party tablet manufacturers contracted by the company. It covers audits of manufacturing facilities, production processes, quality control systems, documentation, and compliance with applicable regulations.
3. Responsibilities
- Quality Assurance (QA) Manager: Responsible for overseeing the entire audit process, including planning, execution, and review of audit findings.
- Auditing Team: Responsible for conducting the audit, reviewing processes, equipment, documentation, and compliance with GMP and regulatory guidelines.
- Procurement Team: Coordinates with third-party manufacturers to schedule and arrange audits.
- Regulatory Affairs Team: Ensures that audits are conducted according to regulatory requirements such as FDA, EMA, and ICH guidelines.
4. Accountability
The QA Manager is accountable for ensuring the auditing process is conducted effectively and in compliance with all regulatory and company standards. The Auditing Team is responsible for executing the audit and documenting their findings.
5. Procedure
5.1 Audit Planning
- Identify the third-party manufacturer to be audited, either based on the scheduled audit or due to a specific requirement (e.g., a new product, regulatory requirement, or performance issues).
- Define the scope of the audit, which should cover the following:
- Manufacturing processes
- Equipment and facilities
- Quality control systems and testing procedures
- Documentation and record-keeping practices
- Compliance with GMP and regulatory standards
- Notify the third-party manufacturer about the audit date, requirements, and expected areas of focus.
- Prepare an audit checklist based on regulatory requirements and company standards (Annexure-1).
5.2 Conducting the Audit
- The Auditing Team arrives at the third-party manufacturing facility and begins the audit by reviewing the audit checklist (Annexure-2).
- Audit the following areas:
- Manufacturing equipment, ensuring it is maintained and calibrated properly
- Production processes, ensuring they comply with approved procedures
- Material storage and handling, verifying that raw materials are stored according to specifications
- Quality control procedures, including testing methods, batch records, and finished product release criteria
- Documentation practices, including batch records, environmental monitoring records, and any deviations or non-conformances
- Compliance with regulatory requirements, such as FDA, GMP, and local regulations
- Interview relevant personnel and request any additional records or documentation needed to verify compliance.
- Observe the production environment and manufacturing practices to ensure cleanliness, safety, and compliance with operational procedures.
5.3 Audit Report and Findings
- After the audit, the Auditing Team compiles all findings into an audit report (Annexure-3). The report should include:
- Summary of the audit findings
- Any non-conformances or deviations from GMP or regulatory guidelines
- Observations on quality control and production practices
- Recommendations for corrective actions
- Request for clarification on any items if necessary
- The audit report should be reviewed and approved by the QA Manager before being shared with the third-party manufacturer.
- If any deviations are found, a follow-up plan should be outlined to address these issues and verify corrective actions.
5.4 Corrective Actions and Follow-Up
- Once the audit report is reviewed, the third-party manufacturer must provide a response outlining corrective actions for any identified deviations or non-conformances (Annexure-4).
- QA and the Auditing Team review the proposed corrective actions and agree on a timeline for their implementation.
- The third-party manufacturer must implement corrective actions and provide documentation or evidence to confirm compliance.
- Schedule a follow-up audit if necessary to verify the effectiveness of corrective actions.
5.5 Documentation and Record Keeping
- Ensure that all audit documents, including checklists, reports, and corrective action plans, are properly documented and stored for future reference (Annexure-5).
- Ensure all documentation is stored securely and is accessible for future reference, audits, or regulatory inspections.
- All records must be retained for a minimum of 5 years, or as required by applicable regulatory guidelines.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- FDA: Food and Drug Administration
- CAPA: Corrective and Preventive Action
7. Documents
- Audit Checklist (Annexure-1)
- Audit Report (Annexure-2)
- Audit Findings and Corrective Actions (Annexure-3)
- Corrective Action Plan (Annexure-4)
- Audit Documentation Records (Annexure-5)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 9001 – Quality Management Systems
- ISO 13485 – Quality Management Systems for Medical Devices
9. SOP Version
Version: 2.0
10. Approval Section
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Approved By |
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11. Annexures
Annexure-1: Audit Checklist
Audit Area |
Checklist Item |
Compliance Status |
Production |
Verify equipment calibration records |
Compliant |
Quality Control |
Review quality control procedures |
Compliant |
Annexure-2: Audit Report
Audit Date |
Audit Area |
Findings |
Corrective Actions |
02/03/2026 |
Manufacturing |
Non-compliant equipment maintenance records |
Corrective maintenance performed, records updated |
Annexure-3: Corrective Action Plan
Action ID |
Action Description |
Completion Date |
CAP-001 |
Recalibrate equipment |
06/03/2026 |
Annexure-4: Supplier Qualification Records
Supplier Name |
Qualification Date |
Audit Result |
ABC Pharma |
01/02/2026 |
Passed |
Annexure-5: Audit Documentation Records
Document Type |
Document Location |
Retention Period |
Audit Reports |
Document Archive |
5 years |
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 auditing procedure |
Clarified responsibilities |
QA Head |