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, assay, degradation products, dissolution, moisture content, and microbiological quality.

4.4 Data Analysis and Interpretation

1. Analyze stability data to determine trends and identify any significant changes in quality attributes over time.
2. Evaluate data against predefined acceptance criteria to assess the stability and shelf life of the product.

4.5 Stability Report

1. Compile stability data, including raw data, calculations, and results, into a comprehensive stability report.
2. Review and approve the stability report to confirm that the study meets the objectives and regulatory requirements.

4.6 Ongoing Stability Program

1. Implement an ongoing stability program to monitor the stability of commercial products throughout their shelf life.
2. Perform periodic stability testing and re-evaluate shelf life as necessary based on stability data.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

Stability Protocol, Stability Testing Records, Stability Report, Raw Data Sheets

7) Reference, if any

Regulatory guidelines such as ICH Q1A(R2) (Stability Testing of New Drug Substances and Products), FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products, EMA guidelines

8) SOP Version

Version 1.0