SOP for Packing Line Clearance – V 2.0

Procedure for Packing Line Clearance

Department	Packaging/Quality Assurance (QA)/Production
SOP No.	SOP/Ointment/096
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 packing line clearance to ensure that packaging operations are conducted in a clean, contamination-free, and organized manner in compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments involved in conducting line clearance before, during, and after packaging operations.

3. Responsibilities

Packaging Operator: Ensures proper clearance of materials and equipment before starting new batches.
Packaging Supervisor: Conducts line clearance checks and records observations.
Quality Assurance (QA) Officer: Verifies and approves line clearance before the start of packaging.
QA Manager: Ensures compliance with GMP and approves final line clearance documentation.

4. Accountability

The QA and Packaging Managers are accountable for ensuring line clearance is conducted before every new packaging batch.

5. Procedure

5.1 Pre-Packaging Line Clearance

Ensure that the packing area is free of any remnants from the previous batch.
Check that no unused materials, labels, or packaging components are left from prior operations.
Verify that all equipment is cleaned and in proper working condition.

5.2 Verification of Packaging Materials

Ensure that the correct batch-specific packaging materials are available.
Verify that the batch number, expiry date, and product details on labels and cartons are correct.
Check that tamper-evident seals and barcodes (if applicable) are available.

5.3 Equipment Readiness

Ensure that all machines (e.g., sealing, labeling, coding) are calibrated and ready for use.
Verify that the printing machine settings are correctly configured.
Perform a test run of the packaging line to confirm smooth operation.

5.4 QA Approval and Documentation

QA must conduct a final inspection before approving line clearance.
Record line clearance details in the Packing Line Clearance Log.
Only after QA approval can the packaging process begin.

5.5 Post-Packaging Line Clearance

Ensure that all unused packaging materials are returned to the designated storage area.
Remove any product residues and clean the packing line thoroughly.
QA must verify and approve post-packaging clearance before releasing the line for the next batch.

6. Abbreviations

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

7. Documents

Packing Line Clearance Checklist (Annexure-1)
Packing Line Clearance 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: Packing Line Clearance Checklist

Date	Batch Number	Packaging Component	Cleared By	Verified By	Remarks
01/02/2025	OINT-101	Labels, Cartons	Packaging Operator	QA Officer	Compliant
01/02/2025	OINT-102	Sealing Machine	Packaging Operator	QA Officer	Compliant

Annexure-2: Packing Line Clearance Approval Report

Date	Batch Number	Packing Line Status	Verified By	Approval Status
01/02/2025	OINT-101	Cleared	QA Manager	Approved
02/02/2025	OINT-102	Cleared	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