phase for gel products in the Gel Manufacturing department of pharmaceutical formulation facilities.

3. Responsibilities

• Production Chemist: To execute the preparation of the water phase as per BMR.
• QA Executive: To verify and document the compliance of preparation steps.
• Engineering Staff: To ensure utility systems (e.g., WFI, purified water) are functional and validated.

4. Accountability

The Head – Manufacturing is accountable for ensuring the availability of trained personnel, equipment readiness, and compliance to SOP.

5. Procedure

5.1 Preparation Requirements

1. Refer to the BMR for specific batch requirements of the water phase.
2. Ensure that the purified water or WFI used is within specified microbial and chemical limits.
3. Check equipment cleanliness status and calibration for water tanks, mixers, and pH meters.

5.2 Dispensing and Charging Water

1. Dispense the required quantity of purified water/WFI into the mixing vessel using calibrated flow meters or volume indicators.
2. Record the lot number of the water used in the BMR and water usage log – Annexure-1.

5.3 Addition of Water-Soluble Components

1. Slowly add water-soluble excipients (e.g., humectants, solubilizers) under stirring.
2. Use a low-shear mixer initially, followed by a high-shear homogenizer if specified in BMR.
3. Ensure each component is fully dissolved before adding the next.

5.4 Temperature and pH Monitoring

1. Maintain water phase temperature within the defined limits (e.g., 25–35°C) for optimal solubilization.
2. Measure and record the pH of the water phase using a calibrated pH meter – Annexure-2.

5.5 Filtration (If Applicable)

1. If specified, filter the water phase through a 0.45 µm or 1.0 µm filter to remove particulate matter before combining with the oil or gel base phase.

5.6 Transfer to Next Processing Stage

1. Upon completion, QA must verify and approve the batch preparation.
2. Transfer the water phase to the holding tank or directly to the main manufacturing vessel for phase combination.
3. Document the transfer in the equipment usage log – Annexure-3.

6. Abbreviations

• BMR: Batch Manufacturing Record
• WFI: Water for Injection
• QA: Quality Assurance

7. Documents

1. Water Usage Log – Annexure-1
2. pH Monitoring Record – Annexure-2
3. Equipment Usage Log – Annexure-3

8. References

• Pharmaceutical Water System Validation SOP
• Schedule M: GMP Guidelines for Pharmaceutical Manufacturing
• USP Monograph for Water for Injection

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: Water Usage Log

Includes date, batch number, quantity used, source of water, and operator signature.

Annexure-2: pH Monitoring Record

Document pH readings at different stages of water phase preparation.

Annexure-3: Equipment Usage Log

Details of equipment used, cleaning status, and transfer time of water phase.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial release	Implementation for new line	QA Head
02/06/2025	2.0	Clarified pH control and filtration steps	Audit observation resolution	QA Head