GMP practices.

2. Scope

This SOP is applicable to all personnel involved in the dispensing of raw materials for intraosseous injection products at the Sterile Injectable Manufacturing facility, including receipt, weighing, labeling, and release.

3. Responsibilities

• Warehouse Chemist: Carries out material dispensing and documentation.
• QA Executive: Conducts verification and approval of dispensed materials.
• Production Pharmacist: Receives and verifies materials before use.
• QC Analyst: Ensures analytical conformity of each material via CoA.

4. Accountability

The Head of Manufacturing shall ensure that all dispensing operations are performed as per this SOP and deviations are investigated and resolved.

5. Procedure

5.1 MRN Verification and Preparation

1. Review the Material Requisition Note (MRN) for completeness and proper authorization.
2. Cross-check the list of required materials against the approved BMR.
3. Ensure availability of valid CoAs and materials with status as “Approved.”

5.2 Weighing Area Control and Setup

1. Perform area cleaning using approved cleaning SOP.
2. Switch ON the RLAF unit and confirm airflow parameters before weighing begins.
3. Arrange labeled weighing tools and accessories in designated sanitized areas.

5.3 Material Weighing and Handling

1. Transport material containers to weighing area after external sanitization with 70% IPA.
2. Weigh materials individually, using pre-calibrated and certified weighing balances.
3. Dispense within the defined limits (±0.1%) as specified in the BMR.
4. Use different tools for different materials to prevent contamination.
5. Log weights in the Material Dispensing Log (Annexure-1) immediately.

5.4 Labeling and Verification

1. Label dispensed containers with: material name, quantity, batch no., dispensed by, date.
2. Complete the Approval and Release Form (Annexure-3) and submit to QA.
3. QA to perform physical verification and document in their review log.

5.5 Release and Transfer

1. After QA approval, materials shall be transferred to the staging area near the aseptic zone.
2. Materials to be segregated by product and labeled clearly to avoid mix-ups.
3. Submit all documentation to QA for archiving and retention.

6. Abbreviations

• SOP: Standard Operating Procedure
• IO: Intraosseous
• QA: Quality Assurance
• QC: Quality Control
• MRN: Material Requisition Note
• CoA: Certificate of Analysis
• BMR: Batch Manufacturing Record

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 TRS 961 Annex 6 – GMP for Sterile Products
• ICH Q9 – Quality Risk Management
• Schedule M – Good Manufacturing Practices (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: Material Dispensing Log

Date	Material	Batch No.	Quantity	Dispensed By	Checked By
17/06/2025	Calcium Gluconate	IO-2025-BN01	100 g	Rajesh Kumar	Sunita Reddy

Annexure-2: Certificate of Analysis (CoA)

Material	Batch No.	Test	Specification	Result	QA Reviewer
Calcium Gluconate	IO-2025-BN01	Assay	95.0–105.0%	98.5%	Ravi Sharma

Annexure-3: Approval and Release Form

Material Name	Calcium Gluconate
Batch Number	IO-2025-BN01
Quantity Dispensed	100 g
Date	17/06/2025
Approved By (QA)	Sunita Reddy

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial SOP implementation	New Manufacturing Line	QA Head
17/06/2025	2.0	Procedure refinement and annexure updates	Annual Review	QA Head