Manager is responsible for ensuring compliance with GMP and regulatory requirements during audits.

5. Procedure

5.1 Color-Coding System for Material Status

1. Approved Materials:
   • Green labels indicate that the material has passed all quality control tests and is approved for use.
   • The label should clearly display “APPROVED” along with essential material information.
2. Quarantined Materials:
   • Yellow labels signify that the material is under quarantine, awaiting quality control testing or further investigation.
   • The label should display “QUARANTINE” and include relevant details such as batch number and receipt date.
3. Rejected Materials:
   • Red labels indicate that the material has failed quality control tests and is rejected for use.
   • The label should display “REJECTED” and the reason for rejection, along with other relevant information.

5.2 Labeling Requirements

1. Label Information:
   • All color-coded labels must include the following:
     • Material Name
     • Batch/Lot Number
     • Supplier Name
     • Manufacturing Date
     • Expiry Date or Retest Date
     • Storage Conditions (if applicable)
     • Status (Approved, Quarantine, Rejected)
2. Label Placement:
   • Place labels on the front-facing side of the container to ensure visibility.
   • Ensure labels are securely affixed and resistant to damage or peeling during handling and storage.

5.3 Labeling Procedures

1. Initial Labeling at Receipt:
   • Upon receipt of raw materials, warehouse personnel must apply the appropriate color-coded label based on the initial status (typically Quarantine).
   • Document all labeling activities in the Labeling Log (Annexure-1).
2. Relabeling Due to Status Changes:
   • When a material’s status changes (e.g., from Quarantine to Approved), replace the existing label with the appropriate color-coded label.
   • Remove or mark obsolete labels to prevent confusion.
   • Document relabeling activities in the Status Change Log (Annexure-2).

5.4 Handling of Damaged or Illegible Labels

1. Inspection of Labels:
   • Regularly inspect labels for signs of damage, fading, or illegibility.
   • Report any issues to the Warehouse Manager and QA for corrective action.
2. Replacement of Labels:
   • Immediately replace any damaged or illegible labels with the correct color-coded label.
   • Document label replacements in the Label Replacement Log (Annexure-3).

5.5 Periodic Review and Compliance Monitoring

1. Warehouse Inspections:
   • Conduct periodic inspections to ensure proper use of color-coded labels.
   • Document inspection findings in the Warehouse Inspection Log (Annexure-4).
2. QA Compliance Audits:
   • QA will perform audits to verify that color-coded labeling complies with GMP and regulatory requirements.
   • Document audit findings in the Compliance Audit Log (Annexure-5).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance

7. Documents

1. Labeling Log (Annexure-1)
2. Status Change Log (Annexure-2)
3. Label Replacement Log (Annexure-3)
4. Warehouse Inspection Log (Annexure-4)
5. Compliance Audit Log (Annexure-5)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO GMP Guidelines

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 Log

Date	Material Name	Batch Number	Status	Labeled By
05/02/2025	API-X	API-X-2025-001	Quarantine	Ravi Kumar

Annexure-2: Status Change Log

Date	Material Name	Batch Number	Previous Status	New Status	Changed By
06/02/2025	API-X	API-X-2025-001	Quarantine	Approved	Anjali Mehta

Annexure-3: Label Replacement Log

Date	Material Name	Batch Number	Reason for Replacement	Replaced By
07/02/2025	API-X	API-X-2025-001	Label Damaged	Sunita Sharma

Annexure-4: Warehouse Inspection Log

Date	Area Inspected	Inspector	Findings	Corrective Actions
08/02/2025	Raw Material Storage Area	Anjali Mehta	All labels in compliance	N/A

Annexure-5: Compliance Audit Log

Date	Audit Type	Findings	Corrective Actions	Audited By
09/02/2025	Color-Coding Compliance Audit	Compliant	N/A	Anjali Mehta

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
05/02/2025	2.0	Updated Labeling Procedures and Documentation Formats	Regulatory Compliance	QA Head