SOP for Handling Interruptions During Ointment Manufacturing – V 2.0

Procedure for Handling Interruptions During Ointment Manufacturing

Department	Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Engineering
SOP No.	SOP/Ointment/199
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a structured approach for handling interruptions during ointment manufacturing to minimize product loss, maintain compliance with GMP standards, and ensure process integrity.

2. Scope

This SOP applies to manufacturing, production, quality assurance, and engineering personnel responsible for managing and documenting interruptions in ointment manufacturing.

3. Responsibilities

Production Supervisor: Identifies and documents manufacturing interruptions.
Process Operator: Ensures proper corrective actions are taken as per SOP.
QA Officer: Assesses potential impact of interruptions on product quality.
QC Analyst: Conducts necessary testing post-interruption.
Engineering Team: Troubleshoots and resolves equipment or utility failures.

4. Accountability

The Head of Manufacturing is accountable for ensuring that all manufacturing interruptions are managed and documented as per GMP regulations.

5. Procedure

5.1 Identifying Types of Interruptions

Classify interruptions into:
- Equipment Failures
- Power Failures
- Raw Material Shortages
- Environmental Conditions (e.g., temperature fluctuations)
Document details in the **Interruption Report Log (Annexure-1).**

5.2 Immediate Actions for Handling Interruptions

Pause the manufacturing process to prevent batch contamination.
Notify the production supervisor and engineering team.
Record immediate corrective measures in the **Corrective Action Log (Annexure-2).**

5.3 Investigating Root Causes

Conduct root

cause analysis using tools such as **5 Whys** or **Fishbone Diagram**.

Identify if the issue is recurring or isolated.

Document findings in the **Root Cause Investigation Report (Annexure-3).**

5.4 Restarting the Manufacturing Process

Perform **line clearance checks** before restarting.
Ensure all equipment is recalibrated and functional.
Verify batch integrity with QA before resumption.
Record batch restart approval in the **Batch Restart Authorization Log (Annexure-4).**

6. Abbreviations

GMP – Good Manufacturing Practices
QA – Quality Assurance
QC – Quality Control
SOP – Standard Operating Procedure
OOS – Out of Specification

7. Documents

Interruption Report Log (Annexure-1)
Corrective Action Log (Annexure-2)
Root Cause Investigation Report (Annexure-3)
Batch Restart Authorization Log (Annexure-4)

8. References

FDA Guidelines on Manufacturing Process Controls
ICH Q9 – Quality Risk Management
WHO GMP Guidelines for Process Deviations

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Interruption Report Log

Date	Batch No.	Type of Interruption	Duration	QA Approval
07/02/2025	OINT-9001	Equipment Failure	30 mins	Approved

Annexure-2: Corrective Action Log

Date	Batch No.	Issue Identified	Corrective Action Taken	QA Approval
07/02/2025	OINT-9001	Power Failure	Switched to backup power	Approved

Annexure-3: Root Cause Investigation Report

Date	Batch No.	Root Cause Identified	Analysis Performed	QA Approval
07/02/2025	OINT-9001	Motor Overheating	5 Whys Analysis	Approved

Annexure-4: Batch Restart Authorization Log

Date	Batch No.	Restart Approved By	Remarks	QA Approval
07/02/2025	OINT-9001	QA Head	Batch integrity maintained	Approved

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
07/02/2025	2.0	Updated handling procedures for major interruptions	Process Improvement	QA Head
01/01/2024	1.0	Initial SOP	New SOP Implementation	QA Head