Procedure for Osmolality Testing

1) Purpose

The purpose of this SOP is to outline the procedure for measuring the osmolality of liquid samples used in pharmaceutical manufacturing to ensure proper formulation and patient safety.

2) Scope

This SOP applies to all liquid formulations produced within the manufacturing facility that require osmolality testing.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting osmolality testing and ensuring compliance with this SOP.
Production Department: Responsible for providing liquid samples and maintaining process parameters.

4) Procedure

4.1 Equipment Preparation:
    4.1.1 Calibrate the osmometer according to the manufacturer’s instructions using certified standard solutions.
    4.1.2 Ensure the sample chamber of the osmometer is clean and free from contaminants.
    4.1.3 Allow the liquid samples to equilibrate to room temperature before testing.

4.2 Osmolality Measurement Procedure:
    4.2.1 Take a sufficient volume of the liquid sample and introduce it into the osmometer sample chamber.
    4.2.2 Initiate the osmolality measurement and allow the instrument to analyze the sample.
    4.2.3 Record the osmolality reading displayed on the osmometer screen.
    4.2.4 Repeat the measurement with fresh samples to ensure accuracy and consistency.

4.3 Calculation and Interpretation:
    4.3.1 Calculate the average osmolality value from the multiple measurements.
    4.3.2 Compare the measured osmolality against acceptance criteria specified in pharmacopeial standards or internal specifications.
    4.3.3 Document any deviations from expected osmolality values and take appropriate corrective actions if necessary.

4.4 Acceptance Criteria:
    4.4.1 The osmolality of the liquid sample meets the specified range or target value as per product requirements.
    4.4.2 Osmometer calibration check is performed at regular intervals and meets acceptance criteria.

4.5 Documentation:
    4.5.1 Record all osmolality measurements, calibration checks, and any corrective actions taken in the Osmolality Testing Record.
    4.5.2 Review and approve the documentation by QC Manager.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Osmolality Testing Record
Calibration Record for Osmometer
Sampling Plan Document

7) Reference, if any

USP General Chapter <785> – Osmolality
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals

8) SOP Version

Version 1.0