StabilityStudies.in

Standard Operating Procedure for Bracketing and Matrixing in Stability Studies Following ICH Q1D

1) Purpose

The purpose of this SOP is to outline the procedure for conducting bracketing and matrixing in stability studies in compliance with ICH Q1D guidelines, optimizing the testing of multiple strengths and packaging configurations.

2) Scope

This SOP applies to all stability studies requiring bracketing and matrixing designs to reduce testing load while maintaining regulatory compliance. It is relevant to departments involved in production, quality control, quality assurance, and regulatory affairs.

3) Responsibilities

• Quality Control (QC) Team: Executes bracketing and matrixing tests as per protocol.
• Quality Assurance (QA) Team: Reviews and approves study designs and ensures compliance with ICH Q1D guidelines.
• Regulatory Affairs Team: Ensures stability data is suitable for regulatory submission.

4) Procedure

1. Study Design Development
   1. Draft a stability study protocol incorporating bracketing or matrixing designs as per ICH Q1D.
   2. Include details
      

      “Future of Drug Stability: How Pharmaceutical Stress Testing Safeguards Against Degradation and Ensures Medication Efficacy”

      on the selection of batches, storage conditions, time points, and test parameters.
   3. Submit the protocol for review and approval by the QA team.
2. Execution of Stability Studies
   1. Conduct stability testing on selected samples according to the approved bracketing or matrixing design.
   2. Document all observations, test results, and deviations from the protocol.
3. Data Analysis and Reporting
   1. Analyze stability data to ensure compliance with ICH Q1D requirements.
   2. Prepare a stability study report and submit it to the Regulatory Affairs team for final review and submission.

5) Abbreviations, if any

• QC: Quality Control
• QA: Quality Assurance
• ICH: International Council for Harmonisation

6) Documents, if any

• Stability Study Protocol
• Analytical Test Reports
• Stability Study Report

7) Reference, if any

• ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0

StabilityStudies.in