dispensing, and sterility assurance.

2. Scope

This SOP applies to all raw material dispensing activities related to the manufacturing of intravenous injections at the Sterile Injectable Manufacturing unit. It covers activities from receipt of material requisition to final transfer to the cleanroom staging area.

3. Responsibilities

• Stores Executive: Responsible for physical dispensing of materials as per requisition.
• Quality Assurance (QA) Officer: Ensures compliance with SOP and monitors documentation and line clearance.
• Production Chemist: Verifies and receives dispensed materials before manufacturing.
• Quality Control (QC): Reviews the CoA and conducts necessary sampling and testing.

4. Accountability

The Head of Sterile Injectable Manufacturing is accountable for ensuring strict compliance with this SOP, proper training of personnel, and timely review of records.

5. Procedure

5.1 Receiving and Preliminary Inspection

1. Receive the approved Batch Manufacturing Record (BMR) or Material Requisition Note (MRN) from the production department.
2. Cross-check material names, quantities, batch numbers, and storage conditions.
3. Inspect material containers for integrity, label clarity, and shelf-life validity.
4. Ensure approved status and CoA availability before proceeding to dispense.

5.2 Documentation and Verification

1. Record each item in the Material Dispensing Log (Annexure-1).
2. Verify the Certificate of Analysis (CoA) of each material (Annexure-2).
3. Ensure the weighed quantity is within specified tolerance (±0.1%).
4. Use calibrated weighing balances and ensure calibration tags are valid.

5.3 Dispensing and Handling of Materials

1. Sanitize the outer surface of containers using 70% IPA prior to bringing them into the weighing booth.
2. Dispense materials in a controlled environment — classified area with reverse laminar airflow (RLAF).
3. Use pre-cleaned, labeled stainless steel or plastic containers for dispensing.
4. Close lids immediately after weighing to prevent contamination.

5.4 Labeling, Approval, and Release of Materials

1. Affix “Dispensed” labels with material name, quantity, batch number, date of dispensing, and operator signature.
2. QA to review and approve each dispensed container using the Approval and Release Form (Annexure-3).
3. Transfer dispensed materials to the designated staging area near the cleanroom entrance.
4. Ensure physical segregation of materials to avoid cross-contamination.

5.5 Documentation and Record-Keeping

1. All entries must be in indelible ink with date, time, and signature.
2. Strike out errors with a single line and provide justification if needed.
3. Ensure all documentation is reviewed by QA before releasing materials for manufacturing.

6. Abbreviations

• SOP: Standard Operating Procedure
• IV: Intravenous
• CoA: Certificate of Analysis
• QA: Quality Assurance
• QC: Quality Control
• MRN: Material Requisition Note
• RLAF: Reverse Laminar Air Flow

7. Documents

1. Material Dispensing Log – Annexure-1
2. Certificate of Analysis (CoA) – Annexure-2
3. Approval and Release Form – Annexure-3

8. References

• WHO GMP Guidelines for Sterile Products
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• Schedule M – Drugs and Cosmetics Rules, India

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Material Dispensing Log

Date	Material Name	Batch No.	Qty Dispensed	Dispensed By	Checked By
17/06/2025	Sodium Chloride	BN-1025	500 g	Rajesh Kumar	Sunita Reddy

Annexure-2: Certificate of Analysis (CoA)

Material	Batch No.	Test	Specification	Result	Approved By
Sodium Chloride	BN-1025	Purity	99.0–100.5%	99.8%	Ravi Sharma

Annexure-3: Approval and Release Form

Material Name	Sodium Chloride
Batch No.	BN-1025
Qty Dispensed	500 g
Date	17/06/2025
QA Approved By	Sunita Reddy

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/04/2022	1.0	Initial version released	New SOP	QA Head
17/06/2025	2.0	Updated procedure and annexures	Annual Review	QA Head