GMP, WHO, and ICH guidelines.

2. Scope

This SOP covers all dispensing operations for active ingredients and excipients used in the formulation of subcutaneous injection products at the Sterile Injectable Manufacturing department.

3. Responsibilities

• Store Executive: Handles material weighing and initial verification.
• QA Officer: Monitors compliance with SOP and signs off on dispensed materials.
• Production Chemist: Verifies and receives dispensed materials.
• QC Personnel: Verifies CoA and material suitability before release.

4. Accountability

The Head of Manufacturing is accountable for ensuring the implementation of this SOP and training of all related personnel.

5. Procedure

5.1 Material Request and Verification

1. Receive MRN from production with batch number, material details, and quantity.
2. Verify storage conditions, integrity of containers, and label clarity.
3. Cross-check material expiry, status label, and CoA availability.

5.2 Weighing Area Preparation

1. Ensure the RLAF unit is functioning and area is cleaned.
2. Place cleaned and calibrated weighing balances in position.
3. Sanitize outer surfaces of all containers with 70% IPA.

5.3 Dispensing Operations

1. Weigh each raw material individually under RLAF using pre-cleaned containers.
2. Use separate spatulas/scoops for each material to prevent contamination.
3. Record details in Material Dispensing Log (Annexure-1) immediately after weighing.
4. Ensure weighing accuracy within permissible limits of ±0.1%.

5.4 Labeling and Documentation

1. Affix label on each container with material name, quantity, batch number, date of dispensing, and operator signature.
2. Fill the Approval and Release Form (Annexure-3) and submit to QA.
3. Maintain traceability through batch linkage to MRN and BMR.

5.5 QA Review and Release

1. QA Officer checks container labels, quantities, and documentation.
2. Signs the release section and authorizes transfer to staging area.
3. Release approved materials to production with acknowledgment.

6. Abbreviations

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

7. Documents

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

8. References

• ICH Q7 – GMP for APIs
• WHO GMP: Good Manufacturing Practices for Pharmaceutical Products
• Schedule M – Drugs and Cosmetics Rules

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Material Dispensing Log

Date	Material	Batch No.	Qty	Dispensed By	Verified By
17/06/2025	Hydroxypropyl Cellulose	SC-1009	100 g	Meena Iyer	Sunita Reddy

Annexure-2: Certificate of Analysis (CoA)

Material	Batch No.	Test	Specification	Result	QA Reviewer
Hydroxypropyl Cellulose	SC-1009	Loss on Drying	≤5.0%	3.8%	Ravi Sharma

Annexure-3: Approval and Release Form

Material Name	Hydroxypropyl Cellulose
Batch Number	SC-1009
Quantity Dispensed	100 g
Date	17/06/2025
Approved By (QA)	Sunita Reddy

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/03/2022	1.0	Initial Issue	New SOP Release	QA Head
17/06/2025	2.0	Revised for clarity and updated annexures	Periodic Review	QA Head