Scope

This SOP is applicable to all dispensed raw materials (actives and excipients) at the sterile injectable manufacturing facility that are to be used in batch manufacturing.

3. Responsibilities

• Warehouse Staff: Responsible for generating and affixing correct labels to dispensed materials.
• QA Officer: Verifies label contents and correctness, signs off for approval.
• Production Pharmacist: Ensures labels match BMR entries before use.

4. Accountability

The Head of Warehouse is accountable for ensuring that no dispensed material leaves the area without a correct and compliant label as per this SOP.

5. Procedure

5.1 Preparation for Labeling

1. Use a printed template as per approved format for all labels to avoid manual errors.
2. Labels must be pre-approved by QA and bear controlled document status.

5.2 Label Format Requirements

1. Each label must contain the following information:
   • Material Name (as per BMR)
   • Material Code
   • Batch Number (Raw Material)
   • Quantity Dispensed (with units)
   • Date of Dispensing
   • Container Number (e.g., 1 of 3, 2 of 3)
   • Dispensed By (initials/signature)
2. Use waterproof adhesive labels printed with clear and legible font (minimum size: 10 pt).

5.3 Labeling Execution

1. Affix the label immediately after completion of each individual material weighing.
2. Ensure the label is securely adhered to the container and is not covering any critical markings.
3. In case of label damage or error, strike the label diagonally, attach a new one, and document the change.

5.4 QA Verification

1. QA shall verify each label against the MRN and BMR before approving it for material release.
2. Labels verified and signed by QA must not be altered without QA reapproval.

5.5 Label Storage and Control

1. Unused printed labels must be accounted for and destroyed in presence of QA.
2. Label issuance and destruction shall be documented in the Label Control Log (Annexure-3).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• MRN: Material Requisition Note

7. Documents

1. Label Template Record – Annexure-1
2. Labeling Verification Log – Annexure-2
3. Label Control Log – Annexure-3

8. References

• WHO GMP – Annex 6
• ICH Q10 – Pharmaceutical Quality System
• Schedule M – Good Manufacturing Practice (India)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Store Chemist	QA Executive	Head – Manufacturing
Department	Warehouse	Quality Assurance	Sterile Injectable Manufacturing

11. Annexures

Annexure-1: Label Template Record

Field	Example
Material Name	Sodium Chloride
Batch No.	BN-12345
Qty Dispensed	500 g
Dispensed On	17/06/2025
Container No.	1 of 2
Initials	RK

Annexure-2: Labeling Verification Log

Date	Material	Batch No.	Label Checked By	Remarks
17/06/2025	Sodium Chloride	BN-12345	Sunita Reddy	OK

Annexure-3: Label Control Log

Date	Label Type	Qty Issued	Qty Used	Qty Destroyed	Verified By
17/06/2025	Dispensed Material Label	10	8	2	QA Executive

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
15/02/2022	1.0	Initial issue	New SOP	QA Head
17/06/2025	2.0	Format updates and label log added	Annual Review	QA Head