SOP for Primary and Secondary Packaging – V 2.0

Procedure for Primary and Secondary Packaging

Department	Packaging/Quality Assurance (QA)/Production
SOP No.	SOP/Ointment/093
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 establish a systematic method for primary and secondary packaging of ointments. This ensures compliance with Good Manufacturing Practices (GMP), product integrity, and regulatory requirements.

2. Scope

This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments involved in the primary and secondary packaging of ointments.

3. Responsibilities

Packaging Operator: Performs primary and secondary packaging operations as per the batch packaging record (BPR).
Packaging Supervisor: Ensures proper material usage and compliance with specifications.
Quality Assurance (QA) Officer: Conducts in-process checks and verifies packaging quality.
QA Manager: Approves the final packaged batch before release.

4. Accountability

The QA and Packaging Managers are accountable for ensuring that packaging operations meet GMP and regulatory requirements.

5. Procedure

5.1 Pre-Packaging Preparation

Ensure that the packaging area is clean and ready for operations.
Verify the availability of approved packaging materials as per the BPR.
Check that equipment settings are correct for primary and secondary packaging.

5.2 Primary Packaging Process

Load ointment tubes into the filling machine.
Ensure that each tube receives the correct quantity of product.
Seal tubes properly and ensure no leakage.
Print batch number, expiry date, and manufacturing date on each tube.

5.3 Secondary Packaging Process

Insert filled ointment tubes into cartons along with patient information leaflets (PILs).
Ensure proper alignment and sealing of cartons.
Apply tamper-evident labels and barcodes if required.

5.4 Inspection and Quality Control

Perform random sampling of packaged products for quality checks.
Verify label accuracy, seal integrity, and carton quality.
QA must approve the packaged batch before dispatch.

5.5 Handling of Rejected Units

Separate defective units and document reasons for rejection.
Dispose of rejected units as per SOP for waste management.
Record all rejected units in the Packaging Defect Log.

5.6 Documentation and Review

Record packaging details in the Packaging Log.
Ensure traceability of all packaged batches for regulatory compliance.
QA must sign off on the final packaged batch before distribution.

6. Abbreviations

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

7. Documents

Packaging Inspection Log (Annexure-1)
Final Packaging 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: Packaging Inspection Log

Date	Batch Number	Packaging Component	Inspected By	Result	Remarks
01/02/2025	OINT-101	Tubes	QA Officer	Pass	Compliant
01/02/2025	OINT-102	Cartons	QA Officer	Pass	Compliant

Annexure-2: Final Packaging Approval Report

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