SOP for Designing Stability Studies in Compliance with ICH Q1A(R2) Guidelines

Standard Operating Procedure for Designing Stability Studies Following ICH Q1A(R2) Guidelines

1) Purpose

The purpose of this SOP is to establish a standardized approach for designing stability studies in compliance with the ICH Q1A(R2) guidelines to ensure that drug substances and products maintain their safety, quality, and efficacy throughout their shelf life.

2) Scope

This SOP applies to all departments involved in the design and execution of stability studies for drug substances and products, including production, quality control, quality assurance, and regulatory affairs.

3) Responsibilities

Quality Control (QC) Team: Responsible for conducting stability tests as per

the study design.

Quality Assurance (QA) Team: Reviews and approves the study design and ensures compliance with regulatory guidelines.

Regulatory Affairs Team: Ensures that stability study protocols comply with ICH Q1A(R2) requirements.

4) Procedure

Protocol Development
1. Develop a stability study protocol that specifies storage conditions (e.g., long-term, accelerated),
  “Mastering Drug Stability: Unveiling the Revised Principles and Practices to Ensure Effective Medication Longevity”
  time points, and tests to be conducted (e.g., potency, purity, dissolution).
2. Include details on sample size, sampling frequency, and acceptance criteria in the protocol.
3. Ensure the protocol is compliant with ICH Q1A(R2) guidelines and submit it for review and approval by the QA team.
Execution of Stability Studies
1. Store samples under specified conditions (e.g., 25°C/60% RH, 40°C/75% RH) in designated stability chambers.
2. Conduct analytical tests at each defined time point to assess stability parameters.
3. Record and document all test results, observations, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze stability data to determine if the product meets the acceptance criteria over the specified time period.
2. Prepare a stability study report and submit it to the QA team for final review and approval.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance
RH: Relative Humidity

6) Documents, if any

Stability Study Protocol
Analytical Test Reports
Stability Study Report

7) Reference, if any

ICH Q1A(R2): Stability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0