Standard Operating Procedure for Preventive Action Reports (PAR) for Deviations

Department	Tablet
SOP No.	SOP/TAB/200/2025
Supersedes	SOP/TAB/200/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To establish the procedure for the identification, documentation, and investigation of deviations from established processes and the initiation of Preventive Action Reports (PARs) to prevent recurrence.

2. Scope

This SOP applies to all tablet manufacturing processes within the facility. It covers the management of deviations from established procedures, identification of root causes, and the development of preventive actions to eliminate recurrence.

3. Responsibilities

• Quality Assurance (QA): Responsible for reviewing and approving PARs, ensuring that corrective and preventive actions are effectively implemented, and verifying that the process remains in control.
• Production Team: Responsible for identifying deviations during tablet manufacturing and reporting them immediately to the QA team. They also assist in implementing corrective and preventive actions.
• Regulatory Affairs: Ensures that the PAR process complies with applicable regulatory requirements, such as FDA and GMP guidelines.
• CAPA Coordinator: Responsible for ensuring that all preventive actions are documented, tracked, and verified for effectiveness.

4. Accountability

The QA Manager is accountable for overseeing the entire PAR process, including approval of preventive actions. The Production Manager is accountable for ensuring that deviations are immediately addressed and that the necessary preventive actions are implemented.

5. Procedure

5.1 Identification of Deviations

1. Monitor manufacturing processes for any deviation from standard operating procedures (SOPs), batch records, or regulatory requirements during tablet production.
2. Identify deviations as soon as they occur and immediately report them to the QA team for review and investigation.
3. Document all deviations in the deviation log (Annexure-1), including details such as the date of occurrence, the operator involved, the nature of the deviation, and the corrective actions taken.

5.2 Documentation of Preventive Action Report (PAR)

1. If a deviation is found to be significant, initiate a Preventive Action Report (PAR) by documenting the event and the root cause analysis in the PAR log (Annexure-2).
2. Include details of the deviation, the reason for its occurrence, the potential impact on product quality, and the proposed preventive actions in the PAR documentation.
3. Ensure that the PAR includes the date of the event, personnel involved, and a summary of the preventive measures to prevent recurrence.

5.3 Root Cause Analysis

1. Conduct a root cause analysis (RCA) for each significant deviation to determine the underlying causes of the event. This may include equipment failure, operator error, material issues, or process inconsistencies.
2. Use appropriate RCA tools such as Fishbone Diagrams, 5 Whys, or Fault Tree Analysis to identify the root cause.
3. Document the findings of the RCA and use them to design effective preventive actions (Annexure-3).

5.4 Preventive Action Implementation

1. Based on the root cause analysis, develop preventive actions aimed at eliminating the root cause of the deviation and preventing its recurrence.
2. Implement corrective actions and preventive actions (CAPA) immediately after the PAR is raised. These may include process adjustments, training, equipment maintenance, or changes in material handling (Annexure-4).
3. Ensure that all corrective actions are tracked and verified for effectiveness during follow-up reviews.

5.5 Monitoring and Effectiveness Check

1. Monitor the effectiveness of the preventive actions implemented through follow-up checks, audits, and process verification.
2. Review any similar deviations or re-occurrence of the issue after the preventive actions have been implemented to verify their success in eliminating the root cause.
3. Document the results of the follow-up checks in the PAR log (Annexure-5) and close the report once it is verified that the preventive actions have been successful.

5.6 Documentation and Record Keeping

1. Maintain all PAR documentation, including deviation reports, root cause analysis findings, and corrective action records, in compliance with regulatory guidelines and internal SOPs.
2. Ensure that all records are properly filed and stored for future reference and audits. These records should be accessible for review during regulatory inspections (Annexure-6).

5.7 Reporting to Regulatory Authorities

1. If required, submit the PAR details to regulatory authorities (e.g., FDA, EMA) for further review and compliance. Include any changes made to manufacturing practices or quality assurance protocols in the submission.
2. Ensure that all regulatory reporting is completed on time and accurately.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• PAR: Preventive Action Report
• RCA: Root Cause Analysis

7. Documents

1. Deviation Log (Annexure-1)
2. PAR Log (Annexure-2)
3. Root Cause Analysis (Annexure-3)
4. CAPA Documentation (Annexure-4)
5. PAR Follow-up Log (Annexure-5)
6. Regulatory Reporting Log (Annexure-6)

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: Deviation Report

Deviation ID	Deviation Description	Operator	Date	Action Taken
DEV-001	Deviation in tablet compression force	John Doe	01/03/2026	Adjusted compression force

Annexure-2: Preventive Action Report (PAR) Log

PAR ID	Deviation Description	Corrective Action	Preventive Action	Completion Date
PAR-001	Deviation in tablet hardness	Recalibrated press	Updated SOPs for press calibration	01/04/2026

Annexure-3: Root Cause Analysis (RCA)

RCA ID	Cause Description	Investigation Findings	Corrective Action
RCA-001	Inconsistent tablet weight	Operator error in material dispensing	Re-trained operator on correct material dispensing

Annexure-4: CAPA Documentation

CAPA ID	Action Description	Responsible Person	Completion Date
CAPA-001	Corrected deviation in tablet weight	Jane Smith	01/05/2026

Annexure-5: PAR Follow-up Log

PAR ID	Follow-up Action	Completion Date	Status
PAR-001	Completed requalification of tablet press	01/05/2026	Completed

Annexure-6: Regulatory Reporting Log

Report	Submission Date	Authority	Status
PAR Submission	01/06/2026	FDA	Submitted

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	Added preventive actions review	Improved corrective actions	QA Head