SOP for Implementing ICH Q1E for Stability Data Evaluation

Guidelines for Stability Data Evaluation as per ICH Q1E

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for evaluating stability data of drug substances and products in accordance with the ICH Q1E guidelines. This SOP ensures consistent and scientifically sound evaluation of stability data to establish the shelf life and storage conditions of pharmaceutical products.

2) Scope

This SOP applies to all personnel involved in the evaluation of stability data for drug substances and products intended for global markets, ensuring compliance with ICH Q1E guidelines.

3) Responsibilities

Stability Testing Team: Responsible

for collecting stability data, performing preliminary data analysis, and ensuring data integrity.

Quality Assurance (QA) Team: Responsible for reviewing the stability data evaluation and ensuring compliance with regulatory requirements.

Regulatory Affairs Team: Responsible for interpreting the results and ensuring that the stability data meets regulatory expectations.

4)
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Procedure

4.1 Initial Data Collection and Review

4.1.1 Collect stability data from all relevant studies, including long-term, accelerated, and intermediate studies.

4.1.2 Review the data for completeness, accuracy, and any out-of-specification (OOS) results or trends.

4.1.3 Ensure that all data has been recorded in accordance with Good Laboratory Practices (GLP) and is traceable.

4.2 Data Analysis and Interpretation

4.2.1 Evaluate the stability data using statistical methods recommended by ICH Q1E, such as regression analysis and determination of confidence intervals.

4.2.2 Identify and assess any trends in the data, including changes in assay values, degradation products, physical appearance, or other relevant parameters.

4.2.3 Determine if the data supports the proposed shelf life and storage conditions based on statistical evaluation.

4.3 Data Reporting and Documentation

4.3.1 Compile a stability data evaluation report that includes the methodology used, data analysis, results, and conclusions.

4.3.2 Ensure that the report is reviewed and approved by the QA Team for accuracy and compliance with ICH Q1E guidelines.

4.3.3 Submit the stability data evaluation report to the Regulatory Affairs Team for submission to the relevant regulatory authorities.

5) Abbreviations, if any

ICH: International Council for Harmonisation
QA: Quality Assurance
OOS: Out-of-Specification
GLP: Good Laboratory Practices

6) Documents, if any

Stability data sheets, stability testing records, stability data evaluation report.

7) Reference, if any

ICH Q1E: Evaluation of Stability Data.

8) SOP Version

Version 1.0