all preservative dispensing activities carried out in the Gel Manufacturing Department for topical gel formulations. It includes commonly used preservatives such as methylparaben, propylparaben, benzyl alcohol, and phenoxyethanol.

3. Responsibilities

• Dispensing Operator: Handles the materials as per the procedure and performs weighing and labeling.
• Supervisor: Verifies the materials, weighing quantity, and ensures proper documentation.
• QA Officer: Performs area clearance, approves weighed material, and ensures compliance.

4. Accountability

The Head of Manufacturing is accountable for ensuring adherence to this SOP and that the dispensing of preservatives is executed under GMP-controlled conditions.

5. Procedure

5.1 Pre-Dispensing Checks

1. Ensure that the material requisition form is approved by production and QA.
2. Check that the selected preservative is within its shelf-life and has a valid Certificate of Analysis (CoA).
3. Perform area clearance and line cleaning before starting the dispensing process.

5.2 Environmental Requirements

1. Maintain room temperature at 20–25°C and relative humidity below 50%.
2. Ensure the dispensing area is free from foreign substances and equipped with calibrated weighing balances.

5.3 Weighing Process

1. Collect the material container from the approved storage area and verify:
   • Material name and code
   • Batch number
   • Quantity
   • Label status (“Approved” by QA)
2. Place a clean and tared container on the balance and dispense the preservative as per the quantity defined in the Batch Manufacturing Record (BMR).
3. Record the actual weighed quantity, balance ID, and operator details in the Preservative Dispensing Log (Annexure-1).

5.4 Handling and Safety

1. Use appropriate PPE such as gloves, mask, and goggles while handling preservatives.
2. Handle volatile preservatives under fume hoods or laminar airflow units to minimize exposure.
3. Immediately close the material container after dispensing to prevent contamination and evaporation.

5.5 Labeling and Cross-Verification

1. Label the dispensed container with:
   • Preservative name and code
   • Batch number
   • Quantity dispensed
   • Date and initials
2. The Production Supervisor must cross-check all information and sign the Verification Sheet (Annexure-2).

5.6 QA Approval and Release

1. QA to inspect the labeled container and confirm the following:
   • Correct labeling and traceability
   • No signs of spillage, degradation, or contamination
2. Release the dispensed material by signing the Approval and Release Form (Annexure-3).

5.7 Documentation and Records

1. Attach all relevant records (CoA, logbook, verification sheet, and release form) to the BMR.
2. Ensure all entries are completed in ink, signed, and dated by responsible personnel.
3. Correct errors by striking through with a single line and providing proper justification.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CoA: Certificate of Analysis
• BMR: Batch Manufacturing Record

7. Documents

1. Preservative Dispensing Log – Annexure-1
2. Verification Sheet – Annexure-2
3. Approval and Release Form – Annexure-3

8. References

• WHO GMP Guidelines
• ICH Q7 – Good Manufacturing Practices 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	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Preservative Dispensing Log

Date	Preservative	Batch No.	Quantity	Weighed By
02/06/2025	Methylparaben	MP0525	0.5 kg	Rajesh Kumar

Annexure-2: Verification Sheet

Item	Observation	Verified By	Date
Material Name	Correct	Sunita Reddy	02/06/2025
Batch Number	Matched	Sunita Reddy	02/06/2025
Quantity	Verified	Sunita Reddy	02/06/2025

Annexure-3: Approval and Release Form

Preservative	Methylparaben
Batch No.	MP0525
Released Quantity	0.5 kg
Approved By	QA Officer
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	Added Annexures and enhanced safety section	Annual Review	QA Head