accountable for ensuring that all SOPs within the department are reviewed periodically and are in compliance with current regulatory and operational standards. The Department Heads are responsible for ensuring that their respective SOPs are updated and reviewed within the required timeframe.

5. Procedure

5.1 SOP Review Frequency

1. All SOPs must be reviewed at least once every year, or more frequently if required by changes in regulatory requirements, internal procedures, or production practices.
2. The review schedule should be planned and documented at the beginning of each year (Annexure-1).
3. If regulatory or operational changes occur during the year, the affected SOPs should be reviewed immediately.

5.2 SOP Review Process

1. At the time of review, the assigned responsible personnel should evaluate whether the SOP is still applicable, and whether the procedures outlined are still effective in meeting operational requirements and regulatory standards.
2. During the review, the following aspects should be checked:
   • Compliance with current GMP and regulatory requirements
   • Relevance to current operational practices
   • Clarity and effectiveness of the instructions
   • Any changes in equipment, materials, or procedures that affect the SOP
3. Input from relevant departments, including production, quality control, and regulatory affairs, should be gathered to ensure that the SOP reflects the latest industry standards and practices.
4. If revisions are necessary, the document should be updated accordingly, and any changes should be clearly documented and explained in the revision history section (Annexure-2).

5.3 SOP Approval

1. Once the review is completed, the updated SOP should be submitted to the QA Manager and/or other relevant personnel for final approval.
2. All revisions to the SOP should be approved before being implemented. Approval should be documented with signatures and dates.
3. Once approved, the new version of the SOP should be distributed to all relevant personnel, and any previous versions should be archived for record-keeping purposes.

5.4 Training and Communication

1. Once an SOP has been reviewed and revised, all relevant personnel should be trained on the new or updated procedures.
2. Training should be documented, and records should be maintained (Annexure-3).
3. Communicate any significant changes in the SOP to ensure that all employees are informed of the latest practices.

5.5 Record Keeping

1. Maintain records of all reviewed and revised SOPs, including the version number, approval date, and any relevant documentation such as revision history, training records, and feedback.
2. Ensure that records are easily accessible for audits and regulatory inspections.

5.6 Deviations and Corrective Actions

1. If any deviations from the SOP are identified during the review process, a corrective action plan should be developed and implemented to address the issue and prevent recurrence.
2. All deviations and corrective actions must be documented and tracked until the issue is resolved (Annexure-4).

6. Abbreviations

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

7. Documents

1. SOP Review Log (Annexure-1)
2. SOP Revision History (Annexure-2)
3. Training Record Log (Annexure-3)
4. Corrective Action Report (Annexure-4)

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: SOP Review Log

Review Date	Reviewed By	Comments	Action Taken
01/03/2026	Jane Smith	No significant changes required	No action taken

Annexure-2: SOP Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version created	New SOP creation	QA Head
01/02/2025	2.0	Clarified review timelines and approval process	Updated review procedures	QA Head

Annexure-3: Training Record Log

Training Date	Trainer	Participants	Topic
01/03/2026	John Doe	All QA Staff	SOP Review Process

Annexure-4: Corrective Action Report

Action ID	Issue	Corrective Action	Completion Date
CAPA-001	Delayed SOP reviews	Improved tracking and follow-up procedure	01/03/2026

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	Clarified review timelines and approval process	Updated review procedures	QA Head