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

1. 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

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

4.3 Monitoring and Maintenance

1. Continuously monitor temperature and humidity conditions