Standard Operating Procedure for Internal Audits of Tablet Manufacturing Facilities

Department	Tablet
SOP No.	SOP/TAB/180/2025
Supersedes	SOP/TAB/180/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To outline the procedures for conducting internal audits in tablet manufacturing facilities to ensure compliance with cGMP guidelines, regulatory requirements, and company standards.

2. Scope

This SOP applies to the internal audit process within the tablet manufacturing department, covering all areas of production, quality control, documentation, and equipment maintenance.

3. Responsibilities

• Quality Assurance (QA): Responsible for planning and coordinating internal audits, conducting audits, and ensuring that audit findings are addressed in a timely manner.
• Audit Team: Responsible for performing the audits in accordance with the established audit checklist, evaluating compliance, and reporting findings.
• Department Heads: Responsible for ensuring that corrective actions are taken and that audit reports are reviewed by relevant personnel.
• All Personnel: Required to cooperate during audits and provide necessary documentation, records, and explanations as requested by the audit team.

4. Accountability

The QA Manager is accountable for overseeing the internal audit process, ensuring audits are scheduled and performed regularly, and that corrective actions are implemented based on audit findings.

5. Procedure

5.1 Audit Planning

1. Plan audits annually, ensuring that all departments and functions within tablet manufacturing are audited at least once a year.
2. Prepare an audit schedule outlining the scope of each audit, audit team members, and the timelines for completion.
3. Notify all relevant departments about the upcoming audits at least two weeks in advance to ensure preparedness.
4. Ensure that audit teams are comprised of trained personnel familiar with cGMP guidelines, company SOPs, and regulatory requirements.

5.2 Audit Checklist

1. Create a comprehensive audit checklist that includes key areas to be evaluated, such as:
   • Raw material handling
   • Equipment calibration and maintenance
   • Production process controls
   • In-process testing and quality control
   • Final product inspection
   • Documentation and record-keeping
   • Personnel training and hygiene
   • Sanitation practices
2. Ensure that the checklist is regularly updated to reflect changes in regulations, equipment, or processes.

5.3 Conducting the Audit

1. The audit team will visit all areas of the tablet manufacturing facility, review records, inspect equipment, and observe processes to assess compliance with cGMP guidelines.
2. Interviews with personnel may be conducted to evaluate their understanding of cGMP practices and their adherence to standard operating procedures (SOPs).
3. Verify that all documentation is complete, accurate, and up to date, and that all necessary records are available for review.
4. Any non-compliance or deviations from SOPs or regulatory requirements must be noted and documented for further action.

5.4 Audit Report

1. At the conclusion of the audit, the audit team will prepare a detailed report outlining their findings, including any deviations from cGMP or company standards, and providing recommendations for corrective actions.
2. The audit report should include:
   • Audit scope and objectives
   • Summary of findings
   • Non-conformities and deviations
   • Corrective and preventive actions (CAPA) required
   • Timeline for implementing corrective actions
3. The audit report should be submitted to the QA Manager and relevant department heads within five business days after the audit.

5.5 Corrective and Preventive Actions (CAPA)

1. Upon receipt of the audit report, department heads must review the findings and implement corrective actions to address any identified non-conformities or deviations.
2. Corrective actions must be documented, and timelines for completion must be established (Annexure-1).
3. Preventive actions must also be identified to ensure that similar issues do not recur in the future.
4. The effectiveness of corrective actions must be monitored and verified by the QA team.

5.6 Follow-up Audits

1. Follow-up audits should be scheduled to verify that corrective actions have been implemented and that they are effective in resolving identified issues.
2. Any unresolved issues or incomplete corrective actions should be addressed and escalated as necessary.

5.7 Audit Records

1. All audit records, including reports, corrective action documentation, and follow-up audit reports, must be maintained for a minimum of five years or as required by regulatory guidelines (Annexure-2).
2. Audit records should be stored securely and be readily accessible for review during regulatory inspections or internal reviews.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• CAPA: Corrective and Preventive Action

7. Documents

1. Audit Report (Annexure-1)
2. Corrective and Preventive Action Plan (Annexure-2)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Corrective and Preventive Action Plan

Action ID	Non-Conformity	Corrective Action	Preventive Action	Completion Date
CAPA-001	Deviation in equipment calibration	Recalibrate equipment	Revise calibration procedure	01/04/2026

Annexure-2: Audit Records

Audit ID	Audit Date	Department Audited	Audit Results	Corrective Actions Taken
AUD-123	01/02/2026	Production	Minor non-conformities found	Recalibration of equipment and documentation review

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 scope and CAPA procedures	Enhanced compliance monitoring	QA Head