Procedure for Visual Inspection During Packing

Department	Packaging/Quality Assurance (QA)/Production
SOP No.	SOP/Ointment/098
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 the process for conducting visual inspection during the packaging of ointments. This ensures product integrity, defect-free packaging, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments responsible for visual inspection of packaging components and final packed products.

3. Responsibilities

• Packaging Operator: Conducts visual inspection of packaging materials and final packed products.
• Packaging Supervisor: Monitors the inspection process and ensures defective units are removed.
• Quality Assurance (QA) Officer: Verifies inspection records and ensures compliance.
• QA Manager: Approves the final inspected batch before distribution.

4. Accountability

The QA and Packaging Managers are accountable for ensuring that all packaged products undergo thorough visual inspection before batch release.

5. Procedure

5.1 Pre-Inspection Preparations

• Ensure that the packaging area is clean and free from contaminants.
• Confirm that proper lighting conditions are available for visual inspection.
• Verify that only trained personnel perform visual inspection tasks.

5.2 Visual Inspection Parameters

• Check packaging materials (cartons, tubes, labels) for any visible defects.
• Inspect printed batch numbers, expiry dates, and barcodes for accuracy.
• Ensure that sealing and tamper-evident features are intact.
• Look for signs of leakage, dents, misalignment, or incorrect labeling.

5.3 Defect Classification

• Critical Defects: Issues that affect product safety or compliance (e.g., missing labels, incorrect expiry date).
• Major Defects: Issues that affect usability but not safety (e.g., smudged print, minor carton damage).
• Minor Defects: Cosmetic issues that do not affect function (e.g., minor label misalignment).

5.4 Handling of Defective Units

• Segregate defective units and document reasons for rejection.
• Investigate the cause of defects and take corrective actions.
• Dispose of or rework defective units as per QA decision.

5.5 Documentation and Approval

• Record visual inspection details in the Inspection Log.
• QA must review and approve the inspected batch before release.
• Ensure traceability of inspected batches for regulatory compliance.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BPR – Batch Packaging Record

7. Documents

• Visual Inspection Log (Annexure-1)
• Final Inspection Approval Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q10 – Pharmaceutical Quality System
• USP <41> – Weights and Balances

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Visual Inspection Log

Date	Batch Number	Inspection Parameter	Inspected By	Result	Remarks
01/02/2025	OINT-101	Label Accuracy	QA Officer	Pass	Compliant
01/02/2025	OINT-102	Seal Integrity	QA Officer	Pass	Compliant

Annexure-2: Final Inspection Approval Report

Date	Batch Number	Inspection Component	Verified By	Approval Status
01/02/2025	OINT-101	Cartons, Labels, Tubes	QA Manager	Approved
02/02/2025	OINT-102	Seals, Barcode	QA Manager	Approved

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