StabilityStudies.in

SOP for Conducting Stability Studies for Nasal Gels

Standard Operating Procedure for Stability Testing of Nasal Gels

1) Purpose

The purpose of this SOP is to establish a procedure for conducting stability studies on nasal gels to ensure they maintain their safety, potency, consistency, and efficacy throughout their shelf life under various storage conditions.

2) Scope

This SOP applies to all nasal gel products manufactured, tested, or stored within the facility. It is relevant to departments involved in production, quality control, quality assurance, and regulatory compliance.

3) Responsibilities

Quality Control (QC) Team: Conducts stability testing, including physical, chemical, and microbiological assessments.
Quality Assurance (QA) Team: Reviews and approves

the stability study protocols and final reports.

Production Team: Provides the necessary samples and maintains accurate production records.

4) Procedure

Sample Preparation
1. Collect representative samples from production batches of nasal gels.
2. Store samples under controlled conditions until the stability study begins.
Development of Stability
Formulation Characterization and Stability of Protein Drugs
Study Protocol
1. Prepare a protocol detailing storage conditions, testing intervals, and analytical methods (e.g., viscosity, pH, microbiological assays).
2. Submit the protocol for review and approval to the QA and Regulatory Affairs teams.
Conducting the Stability Study
1. Store samples in stability chambers under specified conditions (e.g., 25°C/60% RH, 30°C/75% RH).
2. Perform tests at each interval to evaluate the physical, chemical, and microbiological stability of the product.
3. Record all results, observations, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze the stability data to assess whether the nasal gel meets predefined acceptance criteria over time.
2. Prepare a comprehensive report and submit it to the QA team for review and approval.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance
RH: Relative Humidity

6) Documents, if any

Stability Study Protocol
Analytical Test Reports
Stability Study Report

7) Reference, if any

ICH Q1A(R2): Stability Testing of New Drug Substances and Products
FDA Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products

8) SOP Version

Version 1.0