Standard Operating Procedure for pH and Osmolality Control in Nasal Formulations
1) Purpose
The purpose of this SOP is to establish guidelines for controlling the pH and osmolality of nasal formulations to ensure product stability, safety, and patient comfort.
2) Scope
This SOP applies to all personnel involved in the formulation, testing, and quality control of nasal sprays and suspensions at [Company Name].
3) Responsibilities
- Operators: Responsible for monitoring and adjusting pH and osmolality during formulation.
- QA: Verifies that pH and osmolality meet formulation specifications and patient safety requirements.
4) Procedure
4.1 pH Control
4.1.1 Equipment Setup
- Ensure the pH meter is calibrated using standard buffer solutions (e.g., pH 4.0 and pH 7.0) before testing the formulation.
4.1.2 pH Adjustment
- Measure the pH of the formulation, and if necessary, adjust the pH by adding a dilute acid (e.g., HCl) or base (e.g., NaOH) to bring it within the target range.
4.2 Osmolality Control
4.2.1 Equipment Setup
- Ensure that the osmolality meter is calibrated and ready for use.
4.2.2 Osmolality Adjustment
- Measure the osmolality of the formulation. If the osmolality is too high, dilute the formulation
with purified water or another isotonic solution to bring it within the desired range.
4.3 Documentation
- Document all pH and osmolality readings, adjustments, and final values in the batch manufacturing record (BMR).
- Ensure that QA personnel verify and sign off on all pH and osmolality measurements.
5) Abbreviations, if any
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
6) Documents, if any
- Batch Manufacturing Record (BMR)
- pH and Osmolality Log
7) References, if any
- ICH Q3A – Guidelines on Impurities and Stability Testing
8) SOP Version
Version 1.0
Annexure
pH and Osmolality Log Template
| Date | Formulation | pH | Osmolality (mOsm/kg) | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Formulation Name | pH Value | Osmolality | Operator Name | QA Name |