Standard Operating Procedure for Stability Testing Equipment

1) Purpose

The purpose of this SOP is to establish procedures for the operation and maintenance of stability testing equipment used to assess the stability of dental dosage forms over time, ensuring product quality and shelf-life determination.

2) Scope

This SOP applies to all stability testing activities conducted on dental pastes, gels, and mouthwashes within the pharmaceutical industry.

3) Responsibilities

The Quality Control (QC) Department is responsible for executing stability testing procedures. The Equipment Maintenance Department is responsible for maintaining and calibrating stability testing equipment.

4) Procedure

4.1 Equipment Setup and Preparation

4.1.1 Ensure stability testing chambers are clean and sanitized before use.

4.1.2 Calibrate equipment according to manufacturer’s specifications and calibration schedules.

4.2 Sample Preparation

4.2.1 Prepare samples of dental dosage forms as per stability testing protocols and sample storage conditions.

4.2.2 Label samples with necessary identification details including batch number, sampling date, and storage conditions.

4.3 Testing Conditions

4.3.1 Place samples in stability testing chambers under controlled environmental conditions (e.g., temperature, humidity).

4.3.2 Monitor samples at specified intervals according to stability testing timelines.

4.4 Sampling and Analysis

4.4.1 Retrieve samples at designated time points for analysis as per stability testing protocols.

4.4.2 Perform testing and analysis using approved methods to assess product stability (e.g., physical appearance, chemical composition).

4.5 Data Recording and Reporting

4.5.1 Record stability testing data accurately in designated stability study records.

4.5.2 Analyze stability data and prepare stability reports summarizing results and conclusions.

4.6 Equipment Maintenance

4.6.1 Clean and maintain stability testing equipment regularly to ensure reliability and accuracy.

4.6.2 Perform scheduled and preventive maintenance tasks as per equipment maintenance schedules.

5) Abbreviations, if any

SOP – Standard Operating Procedure

QC – Quality Control

6) Documents, if any

Stability Testing Protocols

Stability Study Records

Stability Reports

7) Reference, if any

ICH guidelines for stability testing

Pharmacopeial standards (e.g., USP, EP)

8) SOP Version

Version 1.0