Scope

This procedure applies to all personnel involved in material dispensing operations inside classified areas designated for gel manufacturing in the pharmaceutical facility.

3. Responsibilities

• Dispensing Operator: Responsible for following the dispensing protocol and ensuring proper gowning and hygiene.
• QA Executive: Responsible for verifying compliance, documentation, and periodic audits of dispensing activities.
• Engineering: Responsible for maintaining HVAC systems and differential pressure integrity.

4. Accountability

Head – Quality Assurance is accountable for compliance with this SOP and adherence to GMP standards in the classified area.

5. Procedure

5.1 Entry Protocol for Classified Area

1. Personnel shall wear prescribed sterile gowning as per SOP for gowning in Grade B/Grade C area.
2. Entry shall be through designated airlocks and material shall be passed via dynamic pass boxes only.
3. Record entry/exit time in the classified area logbook (Annexure-1).

5.2 Environmental Controls

• Ensure the classified area maintains Grade B/C environmental conditions per WHO-GMP or ISO 14644 standards.
• Ensure HEPA filters and HVAC systems are functional and parameters like temperature, humidity, and differential pressure are within limits.
• Environmental Monitoring (EM) must be performed and documented before dispensing.

5.3 Material Transfer Procedure

1. Verify the materials to be dispensed against the BMR/BPR and material requisition slip.
2. Material shall be sanitized using 70% IPA spray before transfer through the dynamic pass box.
3. Operator shall accept material in the classified area after UV exposure (15–30 minutes) and external wiping.

5.4 Dispensing Process

1. Verify material label, batch number, expiry, and status label before dispensing.
2. Ensure pre-calibrated balances and stainless steel containers are used.
3. Dispense each material separately and avoid cross-contamination.
4. Affix ‘Dispensed’ label on containers with material name, code, weight, date, and initials.

5.5 Post Dispensing Cleaning

1. Wipe down all surfaces, balance, and dispensing tables with sterile disinfectant.
2. Dispose of all used gloves, masks, and cleaning materials in biohazard bags.
3. Document cleaning activities in the cleaning checklist (Annexure-2).

5.6 Exit Protocol

• Discard outer gown and gloves before exiting the classified area.
• Record exit time and perform hand sanitation.

6. Abbreviations

• HVAC: Heating, Ventilation, and Air Conditioning
• HEPA: High-Efficiency Particulate Air
• EM: Environmental Monitoring
• SOP: Standard Operating Procedure

7. Documents

1. Classified Area Entry Logbook – Annexure-1
2. Dispensing Area Cleaning Checklist – Annexure-2
3. Environmental Monitoring Report – Annexure-3

8. References

• Schedule M – Good Manufacturing Practices
• WHO TRS 961 Annex 6 – GMP for HVAC Systems
• ISO 14644 – Cleanroom Standards

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 Entry Logbook

Date	Name	Entry Time	Exit Time	Remarks
02/06/2025	Operator 1	09:00	10:30	Batch GM23-077

Annexure-2: Cleaning Checklist

Area	Cleaned (✓/✗)	Disinfectant Used	Done By	Remarks
Weighing Bench	✓	IPA 70%	Operator 1	NA

Annexure-3: Environmental Monitoring Report

Location	Particle Count	Temp (°C)	RH (%)	EM Done By
Dispensing Booth	3200	22.5	45	QA Micro

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial Issue	First SOP Release	QA Head
02/06/2025	2.0	Updated procedures and annexures	GMP compliance	QA Head