Procedure for Handling Deviations in Ointment Manufacturing

Department	Production/Quality Assurance (QA)/Quality Control (QC)
SOP No.	DM-030
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 identifying, documenting, investigating, and resolving deviations in ointment manufacturing. Proper deviation management ensures compliance with GMP standards and prevents potential product quality issues.

2. Scope

This SOP applies to all personnel involved in the ointment manufacturing process, including production, quality control (QC), and quality assurance (QA) teams.

3. Responsibilities

• Production Supervisor: Identifies and reports deviations in the manufacturing process.
• QA Personnel: Reviews deviations, initiates investigations, and recommends corrective actions.
• QC Analyst: Conducts testing and verification of affected products.
• Engineering Team: Assists in investigating equipment-related deviations.

4. Accountability

The QA Manager is accountable for ensuring that all deviations are recorded, investigated, and resolved as per GMP standards.

5. Procedure

5.1 Types of Deviations

• Minor Deviation: A deviation that does not affect product quality or GMP compliance.
• Major Deviation: A deviation that impacts product quality, safety, or compliance.
• Critical Deviation: A serious deviation that leads to product rejection or regulatory non-compliance.

5.2 Identification and Reporting

• Any personnel detecting a deviation must report it immediately to the Production Supervisor.
• The deviation must be documented in the Deviation Log with details such as batch number, description, and date.
• The QA team must classify the deviation based on severity.

5.3 Investigation of Deviations

• QA will assign an investigation team to analyze the deviation.
• Root cause analysis (RCA) must be conducted using tools such as:
  • 5-Why Analysis
  • Fishbone Diagram
  • Failure Mode and Effects Analysis (FMEA)
• Determine whether the deviation affects product quality or safety.
• Document investigation findings in the Deviation Investigation Report.

5.4 Corrective and Preventive Actions (CAPA)

• Corrective Action: Immediate measures to correct the deviation.
• Preventive Action: Long-term measures to prevent recurrence.
• QA must approve CAPA plans before implementation.

5.5 Documentation and Approval

• Record all deviation details in the Deviation Log.
• QA must approve all deviations before batch release.
• For critical deviations, a detailed report must be submitted to regulatory authorities if required.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• RCA – Root Cause Analysis
• CAPA – Corrective and Preventive Actions

7. Documents

• Deviation Log (Annexure-1)
• Deviation Investigation Report (Annexure-2)
• CAPA Report (Annexure-3)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practices
• ICH Q10 Pharmaceutical Quality System

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 Log

Date	Batch Number	Deviation Type	Description	Reported By	Verified By
01/02/2025	DM-001	Minor	Mixing time exceeded by 2 minutes	John Doe	QA Officer
02/02/2025	DM-002	Major	Temperature fluctuation during cooling	Jane Smith	QA Officer

Annexure-2: Deviation Investigation Report

Date	Batch Number	Root Cause	Impact on Quality	Investigation By	Final Decision
01/02/2025	DM-001	Operator error	No impact	QA Team	Approved
02/02/2025	DM-002	Equipment malfunction	Requires reprocessing	QA Team	Rework

Annexure-3: CAPA Report

Date	Batch Number	Corrective Action	Preventive Action	Implemented By	Verified By
01/02/2025	DM-001	Retraining of staff	Revised SOP	Production Team	QA Officer
02/02/2025	DM-002	Repaired cooling system	Periodic maintenance schedule	Engineering	QA Officer

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head