labels, cartons, tags, and other packaging materials used for labeling, packing, and shipping of Active Pharmaceutical Ingredients (APIs), intermediates, and reference standards. It includes both in-house and externally printed materials.

3. Responsibilities

• Packaging or Stores Department: Initiates label requests, handles procurement, and submits samples for approval.
• QA Department: Reviews label and artwork content, cross-verifies regulatory data, and maintains label control records.
• QC Department: Verifies printed data during usage and sampling.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that no label or packaging component is used unless approved, validated, and verified for accuracy, GMP compliance, and traceability.

5. Procedure

5.1 Initiation of Label Review

1. The concerned department (e.g., Production, Packaging, Regulatory Affairs) shall submit a Label Approval Request Form (Annexure-1) along with the draft label/artwork or updated design to QA.
2. Label revisions must be supported by Change Control documentation if they affect regulatory content or format.

5.2 Elements of Label/Packaging Review

1. QA shall review labels and printed packaging materials for:
   • Correct Product Name and Code
   • Batch Number placeholder (variable field)
   • Manufacturing Date and Retest/Expiry Date
   • Net weight and packaging size
   • Storage conditions (as applicable)
   • Regulatory declarations (if required)
   • Correct artwork, fonts, color coding, barcodes
   • Revision status and document number
2. Cross-checking shall be done against:
   • Product Specification File
   • Customer/market requirements
   • Previous version for changes
   • Pharmacopoeial or regulatory statements
3. Discrepancies, errors, or deviations shall be documented in the Label Review Comment Form (Annexure-2).

5.3 Approval and Version Control

1. Upon satisfactory review, QA shall:
   • Sign the Label Approval Sheet (Annexure-3)
   • Assign an internal approval number or control ID
   • Record details in the Label Control Register (Annexure-4)
2. Only approved versions shall be printed and used. All obsolete versions shall be marked “OBSOLETE” and archived.

5.4 Printing and Verification

1. Label printing shall be done only against an approved and controlled master copy.
2. During printing and issuance:
   • QA shall verify initial batch-specific overprints (Batch No., Mfg. Date, etc.)
   • Any discrepancies must be reported, and labels segregated
3. Print samples shall be filed with the packaging batch record.

5.5 Usage and Reconciliation

1. QA shall reconcile label issuance and usage for each batch using the Label Usage Log (Annexure-5).
2. Any excess or damaged labels must be destroyed in the presence of QA and recorded accordingly.

5.6 Storage and Security

1. All approved labels and printed packaging materials shall be stored in a restricted access area under lock and key controlled by QA or an authorized person.
2. Obsolete or rejected labels must be removed from access immediately and documented for destruction.

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure
• API: Active Pharmaceutical Ingredient
• ID: Identification

7. Documents

1. Label Approval Request Form (Annexure-1)
2. Label Review Comment Form (Annexure-2)
3. Label Approval Sheet (Annexure-3)
4. Label Control Register (Annexure-4)
5. Label Usage Log (Annexure-5)

8. References

• ICH Q7 – Section 9: Packaging and Identification
• 21 CFR Part 211.122 – Labeling and Packaging Control
• EU GMP Guide Part II – Section 9
• WHO GMP for APIs – TRS 957

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Label Approval Request Form

Product	Code	Requested By	Department	Date
API-X	API01	Rajesh Kumar	Production	12/04/2025

Annexure-2: Label Review Comment Form

Label ID	Observation	Action Suggested	QA Reviewer
LBL/API/001	Incorrect expiry format	Use dd/mm/yyyy	Sunita Reddy

Annexure-3: Label Approval Sheet

Label ID	Version	Approval Date	QA Sign
LBL/API/001	1.0	14/04/2025	QA Head

Annexure-4: Label Control Register

Label ID	Product	Version	Status	Remarks
LBL/API/001	API-X	1.0	Active	—

Annexure-5: Label Usage Log

Date	Batch No.	Label ID	Qty Issued	Qty Used	Qty Destroyed
13/04/2025	API01/2504/001	LBL/API/001	500	480	20

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
14/04/2025	2.0	Updated format and reconciliation process	Regulatory alignment	QA Head