the labels comply with regulatory standards.

Regulatory Affairs Team: Ensures that the product labels meet all relevant local, regional, and international regulatory requirements and that any changes to labeling are approved by the appropriate regulatory authorities.

4. Accountability

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

5. Procedure

5.1. Label Review and Approval

1. Before labeling begins, the QA team will review the labeling design to ensure that it complies with regulatory standards and company policies. The label should include the following information:
   • Product name
   • Ingredients and active substances
   • Usage instructions
   • Batch number and expiration date
   • Safety warnings (e.g., “Pressurized container. Do not pierce or burn.”)
   • Manufacturer’s name and address
   • Regulatory symbols or compliance statements
2. The label design must be approved by both the QA and Regulatory Affairs teams before production labeling starts. Any changes to the label design must undergo a review and approval process.

5.2. Labeling Process

1. Once the label design is approved, the labeling team will receive the prepared labels. Each label should be checked for accuracy before application, ensuring that the correct labels are used for each specific product batch.
2. The labeling team will apply labels to aerosol cans using automated or manual labeling machines, depending on the scale of production. The cans should be inspected to ensure:
   • Correct label placement on the can (i.e., centered, without wrinkles or bubbles).
   • Label edges are properly adhered to prevent peeling.
   • All necessary information is clearly visible and legible.
3. In the event of a labeling error (e.g., incorrect label applied or label misalignment), the affected cans should be removed from the production line and segregated for re-labeling or disposal. The error should be documented in the Labeling Error Log (Annexure-1).

5.3. Labeling Inspection and Verification

1. After the labels are applied, the QA team will conduct a final inspection of a sample of aerosol cans from each batch. The inspection should verify:
   • Label accuracy and completeness (correct product name, ingredients, usage instructions, etc.).
   • Correct placement and adhesion of the label.
   • Compliance with regulatory labeling requirements.
2. If any discrepancies are found during the inspection, the affected cans should be removed from the production line and addressed according to the deviation handling procedure. The issue should be documented in the Deviation Log (Annexure-2).
3. The final batch approval for labeling will only be granted once the QA team has confirmed that the labeling meets all requirements. Once approved, the cans are ready for packing.

5.4. Documentation and Record Keeping

1. All labeling activities, including label review, approval, application, inspection, and any deviations, must be documented in the relevant records:
   • Labeling Approval Log (Annexure-3)
   • Labeling Error Log (Annexure-1)
   • Deviation Log (Annexure-2)
2. Each record should include details such as the batch number, label design version, operator information, and any corrective actions taken.
3. All records must be stored in the document management system for future reference and regulatory inspections. Labeling 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 or compliance issues are identified during the labeling process, they should be reported to the Regulatory Affairs Team immediately. Any necessary reports or notifications to regulatory authorities should be initiated by the Regulatory Affairs Team.
2. The QA team will maintain a summary of labeling compliance during internal audits, ensuring that all processes follow 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. Labeling Error Log (Annexure-1)
2. Deviation Log (Annexure-2)
3. Labeling Approval 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: Labeling Error Log

Error ID	Error Description	Action Taken	Operator Name	Approval
ERR-001	Label misalignment	Re-labeled affected cans	Rajesh Patel	Approved

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Responsible Person	Status
DEV-12345	Incorrect label applied	Re-labeled cans	Rajesh Patel	Completed

Annexure-3: Labeling Approval Log

Batch Number	Approval Date	Approving Authority	Comments
Batch-001	10/02/2025	Anjali Sharma	Approved for packaging

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 labeling procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures