Standard Operating Procedure for Stability Studies

1) Purpose

This SOP outlines the procedures for conducting stability studies on pharmaceutical products to determine their shelf life and ensure that they maintain their intended quality, safety, and efficacy throughout their storage period.

2) Scope

This SOP applies to all pharmaceutical products, including drug substances and drug products, that require stability testing to support their development, registration, and ongoing quality control.

3) Responsibilities

The Stability Studies department or designated personnel are responsible for planning, executing, and documenting stability studies. Quality Assurance (QA), Analytical Development, and other relevant departments are responsible for providing support and ensuring compliance with stability protocols and regulatory requirements.

4) Procedure

4.1 Stability Study Design

1. Develop a stability protocol that outlines the study design, including storage conditions, time points, and testing parameters.
2. Identify the samples to be tested, including the batch number, dosage form, packaging, and storage conditions.

4.2 Sample Storage

1. Store stability samples under controlled conditions (e.g., temperature, humidity) as specified in the stability protocol.
2. Ensure proper labeling and documentation of storage conditions and sample inventory.

4.3 Testing Schedule

1. Perform stability testing at predetermined time points (e.g., 0, 3, 6, 9, 12 months, etc.) according to the stability protocol.
2. Conduct tests to evaluate key quality attributes such as appearance,