materials, including toxic, flammable, corrosive, or reactive substances used in the preparation of sterile injectable products at the pharmaceutical facility.

3. Responsibilities

• Dispensing Operator: Responsible for executing the procedure for hazardous material handling as per SOP.
• Production Supervisor: Ensures all required materials, PPE, and documentation are available and checks adherence.
• Quality Assurance (QA): Verifies documentation, cross-checks procedures, and audits compliance with SOP.
• EHS Officer: Provides hazard information and ensures appropriate safety measures are implemented.

4. Accountability

The Head of Production is accountable for ensuring overall compliance with this SOP and the safe handling of hazardous materials during dispensing operations.

5. Procedure

5.1 Receiving and Preliminary Inspection

1. Receive hazardous raw materials in designated receiving bays.
2. Visually inspect containers for damage, tampering, or leakage.
3. Ensure all containers are labeled with product name, batch number, expiry date, and hazard symbols.
4. Transfer materials to the hazardous material storage area using appropriate transport trolleys and PPE.

5.2 Documentation and Verification

1. Check the Certificate of Analysis (CoA) against material specifications.
2. Verify batch numbers, quantity received, and labeling against purchase orders and delivery challans.
3. Log all entries in the Material Dispensing Log (Annexure-1).

5.3 Dispensing and Handling of Materials

1. Ensure differential pressure and HVAC systems in dispensing area are operational and compliant.
2. Wear full PPE including gloves, face shield, chemical-resistant overalls, and respirator (if required).
3. Place the container inside an appropriate dispensing booth or isolator for containment.
4. Weigh the required quantity using a calibrated balance as per the batch manufacturing record (BMR).
5. Use antistatic mats and grounding clamps if flammable materials are involved.
6. Immediately close and reseal partially used containers, label them appropriately, and return to hazardous storage.

5.4 Labeling, Approval, and Release of Materials

1. Affix “Dispensed” labels on each dispensed container with material name, weight, date, and initials.
2. Allow QA to verify the dispensed quantity and label accuracy.
3. QA releases material with a stamp and signature on Approval and Release Form (Annexure-3).

5.5 Documentation and Record-Keeping

1. Document material code, batch number, quantity dispensed, and initials in the Dispensing Log.
2. Attach a copy of CoA to each batch folder and retain in QA files.
3. Submit copies of all documentation to Production and QA for archival as per documentation policy.

6. Abbreviations

• SOP: Standard Operating Procedure
• PPE: Personal Protective Equipment
• CoA: Certificate of Analysis
• QA: Quality Assurance
• 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 986 Annex 2 – GMP for Pharmaceutical Products
• ICH Q9 – Quality Risk Management
• OSHA Chemical Safety Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Material Dispensing Log

Date	Material Name	Batch No.	Qty Dispensed (g)	Operator
18/06/2025	Sodium Metabisulfite	SMB202506	250	Rajesh Kumar

Annexure-2: Certificate of Analysis (CoA)

Material	Hydroxypropyl Beta-Cyclodextrin
Batch No.	HBC-0618A
Test Performed	LOD, Assay, Identification
Result	Complies
Reviewed By	Sunita Reddy

Annexure-3: Approval and Release Form

Date	18/06/2025
Material Name	Thiocolchicoside
Qty Dispensed	100 g
Verified By (QA)	Pravin Mehta
Status	Approved

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
18/06/2025	2.0	Updated procedure and annexures	Periodic Review	QA Head