for any discrepancies, and ensuring compliance with regulatory requirements.

Regulatory Affairs Team: Ensures that the coding and marking process complies with all applicable local, regional, and international regulations, including labeling and traceability requirements.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all aerosol products are properly coded and marked in accordance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Review of Coding and Marking Requirements

1. Before coding and marking begins, the QA team will review the required coding and marking specifications. This includes:
   • Batch number format
   • Manufacturing date and expiration date format
   • Regulatory compliance information (e.g., warning labels, certification marks)
   • Any other product-specific markings (e.g., serial numbers, product type)
2. The coding and marking requirements must be approved by the QA team and Regulatory Affairs team to ensure compliance with applicable regulations.

5.2. Coding and Marking Process

1. The coding and marking team will use automated coding equipment or manual methods to apply the codes and marks to aerosol cans. The process should include:
   • Batch number
   • Manufacturing date
   • Expiration date
   • Regulatory symbols and compliance marks
   • Any additional product-specific markings
2. The equipment used for coding and marking should be calibrated and maintained according to the equipment maintenance schedule. The Coding and Marking Equipment Log (Annexure-1) should be reviewed to ensure that the equipment is functioning correctly.
3. After the codes are applied, the cans should be inspected to ensure that the information is legible, accurate, and correctly placed. Any cans with incorrect or illegible codes should be flagged for removal and correction.
4. Any errors found in the coding and marking process should be documented in the Coding Error Log (Annexure-2).

5.3. Verification and Inspection

1. The QA team will conduct a verification process to ensure that the correct codes and marks are applied to a random sample of aerosol cans from each batch. The inspection should include:
   • Checking the batch number, manufacturing date, and expiration date for accuracy and clarity.
   • Ensuring that the codes are legible and properly applied without smudges or misprints.
   • Confirming that the required regulatory symbols and information are included on the labels.
2. If any discrepancies are found during the inspection, the affected cans should be segregated, and corrective actions should be taken as necessary. The issue should be documented in the Deviation Log (Annexure-3).
3. Once the batch passes the QA verification, the cans are approved for the next stage of production or packaging.

5.4. Documentation and Record Keeping

1. All coding and marking activities must be documented to ensure traceability and compliance with regulatory requirements. Documentation should include:
   • Batch numbers and corresponding codes
   • Manufacturing and expiration dates
   • Details of any errors or deviations found during the coding process
2. Records should be maintained for all coded and marked aerosol products, and any discrepancies should be investigated and addressed in a timely manner. These records should be stored in the document management system for future reference and audits.
3. All coding and marking records should be retained for a minimum of 3 years or as required by regulatory guidelines.

5.5. Reporting and Compliance

1. If any regulatory issues are identified during the coding and marking process, they should be reported to the Regulatory Affairs Team immediately. The Regulatory Affairs Team will ensure that any necessary corrective actions are taken and that the appropriate notifications are made to regulatory authorities.
2. The QA team will include coding and marking compliance in the internal audit schedule and will review this process regularly to ensure ongoing compliance with GMP and regulatory standards.

6. Abbreviations

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

7. Documents

1. Coding and Marking Equipment Log (Annexure-1)
2. Coding Error Log (Annexure-2)
3. Deviation Log (Annexure-3)

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: Coding and Marking Equipment Log

Equipment ID	Maintenance Date	Calibration Date	Operator Name	Remarks
CME-001	05/02/2025	04/02/2025	Rajesh Patel	Equipment in good working condition

Annexure-2: Coding Error Log

Error ID	Error Description	Action Taken	Operator Name	Approval
ERR-001	Misaligned batch code	Re-applied label and corrected error	Rajesh Patel	Approved

Annexure-3: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Responsible Person	Status
DEV-12345	Incorrect labeling format	Revised labeling format and re-applied labels	Rajesh Patel	Completed

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 coding and marking process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures