to all dispensing operations conducted in classified environments (Grade D/C) for materials used in gel manufacturing including actives, excipients, and preservatives.

3. Responsibilities

• Dispensing Operator: Performs dispensing in accordance with environmental controls.
• QA Officer: Monitors and verifies compliance with environmental specifications.
• Production Chemist: Ensures proper gowning and documentation.

4. Accountability

The Head of Gel Manufacturing and Head of Quality Assurance are accountable for ensuring that dispensing in classified environments is performed in accordance with this SOP and relevant regulatory requirements.

5. Procedure

5.1 Entry to Classified Area

1. Ensure personal hygiene is maintained before entry.
2. Perform gowning as per SOP/QA/045/2023 for entry into Grade D/C areas:
   • Use sterile gloves, face mask, headgear, and coveralls
   • Check for rips, tears, or non-compliance in gowning
3. Pass through airlock ensuring proper door interlocking.

5.2 Area Preparation

1. Verify that the classified dispensing booth is cleaned and sanitized (Annexure-1).
2. Check environmental parameters:
   • Temperature: 20–25°C
   • Humidity: Not more than 60%
   • Differential Pressure: ≥15 Pa between adjacent areas
3. Ensure proper illumination, working exhaust, and HEPA filter functioning.

5.3 Material Movement

1. Receive materials with approved Material Issue Slip and cross-check batch number, description, and quantity.
2. Move materials through a pass box with sanitized surfaces. Use 70% IPA to sanitize each container before placing in the booth.
3. Label the cleaned container “SANITIZED” and enter time, date, and operator initials.

5.4 Dispensing Operation

1. Ensure balance calibration check using standard weights before start.
2. Perform dispensing under laminar airflow (LAF) to ensure Grade A conditions.
3. Record the following in the logbook:
   • Material Name
   • Weighed Quantity
   • Lot Number
   • Operator and verifier signatures
4. Use separate scoops and utensils for each material to prevent cross-contamination.
5. Close the container immediately after weighing and affix “Dispensed” label (Annexure-2).

5.5 Post-Dispensing Activities

1. Clean the weighing balance and discard waste as per SOP/ENV/012/2024.
2. Transfer dispensed containers via pass box to manufacturing.
3. Document all environmental readings in Annexure-3.

5.6 Environmental Controls

1. Monitor viable and non-viable particulate counts at start, mid, and end of dispensing.
2. If environmental parameters deviate, stop the operation and inform QA.

6. Abbreviations

• GMP: Good Manufacturing Practices
• IPA: Isopropyl Alcohol
• LAF: Laminar Air Flow
• SOP: Standard Operating Procedure

7. Documents

1. Classified Area Cleaning Checklist – Annexure-1
2. Dispensed Material Label – Annexure-2
3. Environmental Parameters Log – Annexure-3

8. References

• Schedule M – GMP for Pharmaceuticals
• ISO 14644 Cleanroom Standards
• WHO Technical Report Series

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: Classified Area Cleaning Checklist

Area	Cleaned By	Date	Verified By
Dispensing Booth	Sunita M.	02/06/2025	QA Officer

Annexure-2: Dispensed Material Label

Material Name	Carbomer 940
Batch No.	CB940/0525
Quantity	5.0 kg
Date of Dispensing	02/06/2025
Dispensed By	Operator Signature
Verified By	QA Signature

Annexure-3: Environmental Parameters Log

Date	Temp (°C)	RH (%)	Pressure (Pa)	Particle Count	CFU	Checked By
02/06/2025	23	47	17	3200	4	QA Executive

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
02/06/2022	1.0	Initial Version	New SOP	QA Head
02/06/2025	2.0	Added enhanced gowning and airlock steps	Annual Review	QA Head