that all packaged products are stored correctly and that the packaging documentation is accessible for future reference and audits.

4. Accountability

The Manufacturing Manager is accountable for ensuring that packaging operations are documented according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Documentation During Packaging Operations

1. During each stage of the packaging process, relevant data must be recorded in the appropriate logs. This includes:
   • Filling logs (to record the fill weight, equipment used, operator information, and batch number)
   • Sealing logs (to document the sealing integrity, equipment used, operator information, and inspection results)
   • Labeling logs (to ensure that the correct labels are applied, documenting any errors or corrections)
   • Packaging logs (to record the materials used for packaging and the condition of the finished packs)
2. Each log must include the following information:
   • Batch number
   • Operator’s name and signature
   • Date and time of packaging operations
   • Details of any deviations or issues encountered and the corrective actions taken
3. The completed logs should be signed by the responsible operator and reviewed by the QA team to verify compliance with the packaging specifications and regulatory requirements.

5.2. Verification of Packaging Documentation

1. The QA team will verify that the documentation for each packaging operation is complete, accurate, and complies with the packaging requirements. This verification will include:
   • Checking the completeness of the logs, ensuring that all required fields are filled out.
   • Verifying that the information entered in the logs matches the packaging batch records.
   • Ensuring that any deviations or non-conformances are appropriately documented and corrective actions are noted.
2. Any discrepancies or missing documentation should be immediately reported to the production supervisor for resolution. A non-conformance report should be generated and documented in the Deviation Log (Annexure-1).

5.3. Documentation Storage and Record Keeping

1. All packaging documentation must be stored in an organized and secure location, ensuring that records are easily retrievable for future reference, audits, or regulatory inspections.
2. Packaging logs should be maintained for a minimum of 3 years, or as required by regulatory guidelines. All records should be stored electronically or in hard copy, depending on the company’s document management system.
3. Records should be readily available for internal audits and external regulatory inspections to demonstrate compliance with GMP and regulatory standards.

5.4. Training for Documentation Practices

1. All personnel involved in packaging operations must be trained on the importance of accurate documentation and the specific requirements for completing packaging logs.
2. Training should include:
   • How to properly complete each section of the packaging logs.
   • The importance of traceability and record-keeping for regulatory compliance.
   • How to identify and report discrepancies or deviations in the packaging process.
3. Training records should be maintained in the Employee Training Log (Annexure-2), and all employees should undergo refresher training annually.

5.5. Reporting and Compliance

1. If any discrepancies or errors are identified in the packaging documentation, they must be reported to the QA team immediately. The QA team will review the issue and initiate corrective actions, including retraining if necessary.
2. Compliance with this SOP will be monitored through internal audits and periodic reviews of packaging records by the QA team to ensure ongoing adherence to regulatory standards and company policies.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure
• QA: Quality Assurance

7. Documents

1. Filling Log (Annexure-3)
2. Sealing Log (Annexure-4)
3. Labeling Log (Annexure-5)
4. Packaging Log (Annexure-6)
5. Deviation Log (Annexure-1)
6. Employee Training Log (Annexure-2)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

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

Deviation ID	Deviation Description	Corrective Action	Responsible Person	Status
DEV-12345	Missing batch number on packaging log	Completed the batch number field and re-verified	Rajesh Patel	Completed

Annexure-2: Employee Training Log

Employee Name	Training Date	Training Topic	Trainer	Signature
Rajesh Patel	10/02/2025	Packaging Documentation	Anjali Sharma	Signed

Annexure-3: Filling Log

Batch Number	Fill Weight	Operator Name	Time	Remarks
Batch-001	500g	Rajesh Patel	10:00 AM	All cans filled within specified limits

Annexure-4: Sealing Log

Batch Number	Seal Integrity Check	Operator Name	Time	Remarks
Batch-001	Pass	Rajesh Patel	10:30 AM	No issues detected

Annexure-5: Labeling Log

Batch Number	Labeling Check	Operator Name	Time	Remarks
Batch-001	Pass	Rajesh Patel	11:00 AM	Labels applied correctly

Annexure-6: Packaging Log

Batch Number	Packaging Type	Operator Name	Time	Remarks
Batch-001	Cartons	Rajesh Patel	11:30 AM	Packaging completed successfully

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated documentation procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures