SOP for Stability Storage Conditions

Guidelines for Stability Storage Conditions of Vaginal Dosage Forms

1) Purpose

The purpose of this SOP is to define the storage conditions for stability testing of vaginal dosage forms to ensure consistent and reliable data on product stability over time.

2) Scope

This SOP applies to all vaginal dosage forms that are subjected to stability testing within the pharmaceutical manufacturing facility.

3) Responsibilities

The Quality Control (QC) Department is responsible for ensuring the stability storage conditions are maintained as per the stability study protocol. The Quality Assurance (QA) Department is responsible for overseeing compliance with the defined storage conditions.

4) Procedure

4.1 Stability Storage Conditions

Define the storage conditions for stability testing as per regulatory guidelines and product-specific requirements. Typical conditions include:
1. Long-term storage: 25°C ± 2°C / 60% RH ± 5% RH
2. Accelerated storage: 40°C ± 2°C / 75% RH ± 5% RH
3. Intermediate storage: 30°C ± 2°C / 65% RH ± 5% RH
4. Refrigerated storage: 5°C ± 3°C
5. Freezer storage: -20°C ± 5°C

4.2 Stability Chambers

Ensure stability chambers are qualified and calibrated according to relevant SOPs.
Place samples in stability chambers that match the defined storage conditions for the stability study.
Use labeled racks or trays to organize samples and prevent mix-ups.

4.3 Monitoring and Maintenance

Continuously monitor temperature and humidity conditions

within stability chambers using calibrated devices.

Document any deviations from the defined storage conditions and take corrective actions as necessary.

Perform routine maintenance and calibration of stability chambers to ensure consistent performance.

4.4 Data Logging and Review

Maintain data logs for temperature and humidity conditions within the stability chambers.
Regularly review data logs to ensure compliance with the defined storage conditions.
Investigate and document any deviations, including the impact on stability studies and corrective actions taken.

4.5 Backup and Contingency Plans

Develop and implement backup and contingency plans for stability storage in case of equipment failure or other emergencies.
Ensure alternative storage facilities are qualified and capable of maintaining the required conditions.

5) Abbreviations, if any

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

6) Documents, if any

Stability study protocol, stability chamber qualification records, temperature and humidity data logs

7) Reference, if any

ICH Q1A(R2): Stability Testing of New Drug Substances and Products, WHO Guidelines for Stability Testing of Pharmaceutical Products

8) SOP Version

Version 1.0