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SOP for Preparing a Stability Protocol in Accordance with ICH Q1A(R2)

Standard Operating Procedure for Preparing Stability Protocols Following ICH Q1A(R2) Guidelines

1) Purpose

The purpose of this SOP is to provide a standardized procedure for preparing a stability protocol in compliance with the ICH Q1A(R2) guidelines to ensure the quality, safety, and efficacy of drug substances and products over their shelf life.

2) Scope

This SOP applies to all stability studies conducted to comply with ICH Q1A(R2) guidelines. It is relevant to departments involved in quality control, quality assurance, and regulatory affairs.

3) Responsibilities

Quality Assurance (QA) Team: Develops and reviews the stability protocol.
Quality Control (QC)

Team: Executes testing as per the approved protocol.

Regulatory Affairs Team: Ensures the protocol meets regulatory submission requirements.

4) Procedure

Protocol Development
1. Identify the parameters to be included in the stability protocol, such as storage conditions, time points, test methods, and acceptance
  “Ensuring Pharmaceutical Purity and Potency: Unveiling Effective Techniques for Reliable Stability Testing and Quality Control”
  criteria.
2. Draft the protocol according to ICH Q1A(R2) guidelines, specifying all necessary details.
3. Submit the draft protocol to the QA team for review and approval.
Protocol Approval
1. Ensure that the protocol meets all regulatory requirements and guidelines.
2. Obtain final approval from the QA and Regulatory Affairs teams before commencing the stability study.
Execution of Stability Study
1. Follow the approved protocol for conducting stability studies, ensuring that all specified conditions, time points, and tests are adhered to.
2. Record all observations, test results, and any deviations from the protocol accurately and comprehensively.
Data Review and Finalization
1. Review all data generated from the stability study to ensure consistency with the protocol and regulatory guidelines.
2. Prepare a final report summarizing the stability data, findings, and any necessary actions.

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

8) SOP Version

Version 1.0