Guidelines for Conducting Stability Testing on Vaginal Dosage Forms

1) Purpose

The purpose of this SOP is to outline the procedures for conducting stability testing on vaginal dosage forms to ensure they maintain their quality, safety, and efficacy throughout their shelf life.

2) Scope

This SOP applies to all personnel involved in the stability testing of vaginal dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The Quality Control (QC) Department is responsible for setting up, monitoring, and analyzing stability studies. The Quality Assurance (QA) Department is responsible for reviewing the stability data and ensuring compliance with regulatory requirements.

4) Procedure

4.1 Preparation for Stability Testing

1. Identify the batches of vaginal dosage forms to be included in the stability study based on regulatory requirements and internal guidelines.
2. Prepare the stability study protocol, including the testing schedule, storage conditions, and test parameters.
3. Label and store samples in stability chambers set to specific environmental conditions (e.g., temperature, humidity) as per the study protocol.

4.2 Stability Testing Schedule

1. Conduct initial testing (T0) on the samples to establish baseline data.
2. Perform subsequent testing at defined intervals (e.g., 1 month, 3 months, 6 months, 12 months, 24 months) as specified in the stability protocol.

4.3 Stability Test Parameters

1. Conduct the following tests on stability samples: appearance, assay, degradation products, dissolution, pH, microbial limits, and any other product-specific tests.
2. Document all test results in the stability study records.

4.4 Data Review and Analysis

1. QC Department compiles and reviews stability data to identify trends or significant changes in the product’s quality attributes.
2. QA Department reviews the compiled data for compliance with the predefined acceptance criteria.
3. Investigate any out-of-trend (OOT) or out-of-specification (OOS) results as per the relevant SOP.

4.5 Reporting and Documentation

1. Prepare stability study reports summarizing the test results, data analysis, and conclusions regarding the product’s stability.
2. QA Department reviews and approves the stability study reports.
3. Retain stability study records and reports according to regulatory requirements and company policy.

4.6 Regulatory Compliance

1. Ensure that stability testing procedures and documentation comply with relevant regulatory guidelines (e.g., ICH, WHO).
2. Submit stability data to regulatory authorities as required for product approval or re-registration.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance
OOT: Out-of-Trend
OOS: Out-of-Specification

6) Documents, if any

Stability study protocol, stability study records, stability study reports

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