dispensing operations of all raw materials required for gel formulations within the dedicated dispensing areas of the Gel Manufacturing facility.

3. Responsibilities

• Warehouse Staff: Responsible for picking and transferring raw materials to the dispensing area.
• Dispensing Operator: Carries out weighing and labeling of materials under supervision.
• Quality Assurance (QA): Performs area clearance, verification of labels, and release of dispensed materials.
• Production Pharmacist: Ensures reconciliation of received materials and records all transactions.

4. Accountability

The Manufacturing Head is accountable for ensuring adherence to this SOP and that materials are dispensed in accordance with GMP and regulatory expectations.

5. Procedure

5.1 Receiving and Preliminary Inspection

1. Ensure material requisition is raised for the required batch and formulation.
2. Cross-check the material against approved QC clearance and stock status.
3. Inspect the condition of the container, seals, and labeling before dispatching to the dispensing area.

5.2 Documentation and Verification

1. Enter each material into the Material Dispensing Log (Annexure-1) with lot number and quantity.
2. Ensure Certificate of Analysis (Annexure-2) is available and corresponds with the material.
3. Verify calibration of weighing balance and record balance ID.

5.3 Dispensing and Handling of Materials

1. Perform area line clearance by QA before commencing dispensing.
2. Weigh material as per the Batch Manufacturing Record using designated, cleaned containers.
3. Handle sensitive materials (e.g., light-sensitive or moisture-sensitive) under appropriate conditions.
4. Record exact quantity weighed and any discrepancies observed.

5.4 Labeling, Approval, and Release of Materials

1. Affix a Dispensed Material Label containing material name, code, batch number, quantity, date, and analyst initials.
2. Supervisor verifies and initials on the label tag.
3. QA Officer releases the material after cross-verification and signs the Approval and Release Form (Annexure-3).

5.5 Documentation and Record-Keeping

1. Attach copies of the label, dispensing log, and CoA to the batch record.
2. All records should be legible, traceable, and signed with date and time.
3. Any correction must be struck-through with a single line, signed, and justified with remarks.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• 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 GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Schedule M – Drugs and Cosmetics Act (India)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Material Dispensing Log

Date	Material Name	Batch No.	Quantity	Dispensed By
02/06/2025	Carbopol 940	CBP94001	20.0 kg	Rajesh Kumar

Annexure-2: Certificate of Analysis (CoA)

Material	Carbopol 940
Batch No.	CBP94001
Manufacturer	ABC Polymers Pvt. Ltd.
Mfg Date	01/05/2025
Expiry Date	30/04/2027
QC Approval	Approved

Annexure-3: Approval and Release Form

Material	Carbopol 940
Dispensed Quantity	20.0 kg
Verification Status	Verified
Released By (QA)	Sunita Reddy
Release Date	02/06/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New SOP	QA Head
02/06/2025	2.0	Annexures added, format revised	Annual Review	QA Head