and ICH guidelines.

2. Scope

This SOP applies to all dispensing operations related to the preparation of intramuscular injection formulations conducted at the Sterile Injectable Manufacturing facility.

3. Responsibilities

• Warehouse Staff: Responsible for dispensing raw materials as per production requirements.
• Production Chemist: Reviews requisition and receives dispensed materials.
• QA Officer: Verifies dispensing records, ensures compliance, and authorizes material release.
• QC Personnel: Confirms material quality through CoA verification and sampling.

4. Accountability

The Head of Sterile Injectable Manufacturing is accountable for the implementation, compliance, and periodic review of this SOP.

5. Procedure

5.1 Receiving Material Requisition

1. Receive signed MRN from the Production department with material specifications, batch sizes, and required quantities.
2. Check that MRN is authorized and complete.

5.2 Verification and Line Clearance

1. Check material containers for intact packaging, labeling, and expiry status.
2. Review CoA and cross-verify against batch number and specification.
3. Ensure designated weighing area is cleaned and cleared (line clearance to be documented).

5.3 Material Weighing and Dispensing

1. Carry materials into the classified weighing booth under RLAF after sanitizing outer surfaces.
2. Use pre-cleaned containers and calibrated weighing balances with valid calibration status.
3. Dispense each material accurately within ±0.1% of the specified weight.
4. Document each weighing in the Material Dispensing Log (Annexure-1).

5.4 Labeling and QA Verification

1. Affix labels with details such as material name, quantity, batch number, date, and dispensed by.
2. Present all containers and documentation for QA verification.
3. QA to fill and sign the Approval and Release Form (Annexure-3).

5.5 Transfer and Documentation

1. Transfer labeled and approved materials to the pre-cleanroom staging area.
2. Ensure segregation of actives and excipients in transit.
3. Ensure all dispensing documentation is signed and filed for traceability.

6. Abbreviations

• SOP: Standard Operating Procedure
• IM: Intramuscular
• CoA: Certificate of Analysis
• MRN: Material Requisition Note
• QA: Quality Assurance
• QC: Quality Control
• 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 – Annex 6: Manufacture of Sterile Medicinal Products
• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• Schedule M – Indian GMP Requirements

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: Material Dispensing Log

Date	Material Name	Batch No.	Qty Dispensed	Dispensed By	Checked By
17/06/2025	Benzyl Alcohol	BN-IM125	250 mL	Rajesh Kumar	Sunita Reddy

Annexure-2: Certificate of Analysis (CoA)

Material	Batch No.	Test	Specification	Result	Approved By
Benzyl Alcohol	BN-IM125	Purity	98.0–102.0%	99.5%	Ravi Sharma

Annexure-3: Approval and Release Form

Material Name	Benzyl Alcohol
Batch No.	BN-IM125
Qty Dispensed	250 mL
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 release	New SOP	QA Head
17/06/2025	2.0	Updated procedures and annexures	Periodic Review	QA Head