Procedure for Conducting Stability Studies According to ICH Guidelines
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting stability studies in accordance with the International Council for Harmonisation (ICH) guidelines to ensure global regulatory compliance for drug substances and products.
2) Scope
This SOP applies to all drug substances and products that require stability testing as per ICH guidelines for global market submissions. It is relevant for personnel in quality control, research and development, and regulatory affairs departments.
3) Responsibilities
The responsibilities for conducting stability studies in line with
ICH guidelines are as follows:
- Quality Control Team: To perform the stability tests as per the protocol and document results.
- R&D Team: To design the stability study protocol in accordance with ICH guidelines and provide technical support.
- Regulatory Affairs Team: To ensure compliance with ICH guidelines during stability testing.
- Stability Study Coordinator: To manage testing schedules, sample management, and data analysis.
4) Procedure
The detailed stepwise procedure for conducting stability studies in line with ICH guidelines is outlined below:
- Preparation of Stability Study Protocol:
- 4.1 Define the purpose, scope, and objective of the stability study in accordance with ICH guidelines.
- 4.2 Identify the drug substance or product and critical quality attributes (CQAs) to be monitored (e.g., potency, degradation products, dissolution rate).
- 4.3 Determine the storage conditions to be tested (e.g., long-term, accelerated, intermediate conditions).
- 4.4 Establish the time points for testing at each storage condition (e.g., 0, 3, 6, 12, 24 months).
- 4.5 Develop a protocol outlining procedures, equipment, and materials required for testing.
- Sample Preparation and Storage:
- 4.6 Select representative samples of the drug substance or product for testing.
- 4.7 Prepare and package samples in their final storage configuration.
- 4.8 Store samples under specified conditions in stability chambers or other controlled environments.
- Testing and Monitoring:
- 4.9 Retrieve samples at specified time points and perform the required tests (e.g., assay, degradation products, dissolution rate).
- 4.10 Record all test results in a stability testing log sheet.
- 4.11 Evaluate the results against predefined acceptance criteria.
- Data Analysis and Interpretation:
- 4.12 Analyze the stability data to identify any trends or deviations in the quality attributes.
- 4.13 Determine the impact of different storage conditions on the stability of the drug substance or product.
- 4.14 Document any significant findings or trends in the data.
- Documentation and Reporting:
- 4.15 Compile a comprehensive stability study report including objectives, methods, results, and conclusions.
- 4.16 Ensure the report is reviewed and approved by relevant stakeholders.
- 4.17 Submit the report to regulatory bodies or internal stakeholders as required.
- Review and Update:
- 4.18 Regularly review the stability study protocol and update it based on new data or regulatory changes.
- 4.19 Archive the approved protocol and report in a controlled document management system.
5) Abbreviations, if any
- CQA: Critical Quality Attribute
- ICH: International Council for Harmonisation
6) Documents, if any
- ICH Compliance Stability Study Protocol
- Stability Testing Log Sheets
- Stability Study Report Template
7) Reference, if any
- ICH Q1A(R2): Stability Testing of New Drug Substances and Products
- ICH Q1B: Photostability Testing of New Drug Substances and Products
- ICH Q1E: Evaluation of Stability Data
8) SOP Version
Version 1.0