Procedure for Stability Testing According to ANVISA Guidelines

1) Purpose

The purpose of this SOP is to establish the procedure for conducting stability studies in compliance with the guidelines of the Brazilian Health Regulatory Agency (ANVISA). This ensures that drug products marketed in Brazil maintain their safety, efficacy, and quality throughout their shelf life.

2) Scope

This SOP applies to all personnel involved in the stability testing of drug products intended for the Brazilian market, including formulation, quality control, and regulatory affairs teams.

3) Responsibilities

Formulation Team: Responsible for developing the drug formulation and selecting appropriate packaging.
Stability Study Team: Responsible for executing stability studies according to ANVISA guidelines.
Regulatory Affairs Team: Responsible for ensuring that all stability data meets ANVISA requirements.

4) Procedure

4.1 Preparation of Stability Protocol

4.1.1 Develop a stability testing protocol following ANVISA guidelines, which should include the testing of

physical, chemical, microbiological, and biological properties.

4.1.2 Define test conditions (e.g., temperature, humidity) and intervals for testing (e.g., 0, 3, 6, 12, 24 months).

4.2 Sample Collection and Storage

4.2.1 Collect samples of the drug product from representative batches for stability testing.

4.2.2 Store samples under specified conditions as per ANVISA guidelines (e.g., 30°C/75% RH for