Standard Operating Procedure for Setting Parameters for Different Intravenous (IV) Solutions

1) Purpose

The purpose of this SOP is to define the procedures for setting and adjusting parameters on manufacturing equipment for different intravenous (IV) solutions to ensure product quality and consistency.

2) Scope

This SOP applies to all personnel involved in the preparation and manufacturing of IV solutions within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Production Supervisors

• Ensure proper setup and parameter adjustment for different IV solutions.
• Monitor equipment performance during production runs.

3.2 Quality Assurance (QA) Personnel

• Verify equipment settings and parameters to meet product specifications.
• Review and approve equipment configuration changes.

4) Procedure

4.1 Parameter Settings Preparation

1. Review batch records and formulation details for specific IV solution.
2. Identify equipment parameters required for manufacturing (e.g., temperature, pressure).

4.2 Equipment Setup and Adjustment

1. Calibrate manufacturing equipment according to established procedures.
2. Adjust parameters based on formulation requirements and equipment capabilities.

4.3 Verification and Testing

1. Perform test runs or pilot batches to validate equipment settings.
2. Monitor critical process parameters during production to ensure consistency.

4.4 Documentation and Reporting

1. Document equipment settings and parameter adjustments in batch records.
2. Report any deviations or equipment malfunctions to supervisors and QA.

5) Abbreviations, if any

SOP: Standard Operating Procedure; IV: Intravenous; QA: Quality Assurance

6) Documents, if any

• Batch Records
• Equipment Calibration and Setup Logs
• Equipment Configuration Change Requests

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
USP General Chapter <1231>: Water for Pharmaceutical Purposes

8) SOP Version

Version 1.0