SOP for Performing Stability Studies for Ophthalmic Ointments

Standard Operating Procedure for Stability Testing of Ophthalmic Ointments

1) Purpose

The purpose of this SOP is to provide a standardized procedure for conducting stability studies on ophthalmic ointments to ensure they maintain their potency, sterility, and physical characteristics throughout their shelf life.

2) Scope

This SOP applies to all ophthalmic ointments 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 sterility, potency, and physical examination (e.g., viscosity, particle size).
Quality Assurance (QA) Team: Reviews and approves

stability study protocols and reports.

Production Team: Provides necessary samples and maintains proper documentation of production records.

4) Procedure

Sample Preparation
1. Obtain representative samples of ophthalmic ointments from production batches.
2. Store samples under appropriate conditions until stability testing begins.
Design of Stability Study
1. Prepare a protocol outlining storage conditions,
  “Ensuring Product Longevity: A Comprehensive Guide to Pharmaceutical Stability Testing for Global Market Success”
  test intervals, and analytical methods (e.g., sterility testing, viscosity testing).
2. Submit the protocol for approval by the QA and Regulatory Affairs teams.
Execution of Stability Study
1. Store samples in designated stability chambers under controlled conditions (e.g., 25°C/60% RH).
2. Perform tests at each interval to evaluate sterility, potency, and physical characteristics.
3. Record all test results, observations, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze the data to determine any changes in the product’s sterility, potency, or physical characteristics over time.
2. Prepare a detailed stability study 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
USP General Chapter <771>: Ophthalmic Products – Quality Tests

8) SOP Version

Version 1.0