Procedure for Evaluating the Effect of Temperature on Drug Stability
1) Purpose
The purpose of this SOP is to provide a detailed procedure for determining the impact of temperature on the stability of drug substances and products. This evaluation helps in understanding the effects of various temperature conditions on the quality, safety, and efficacy of the drug.
2) Scope
This SOP applies to all drug substances and products that require stability testing under various temperature conditions to determine their shelf life and appropriate storage requirements. It is relevant for personnel in quality control,
research and development, and regulatory affairs departments.
3) Responsibilities
The responsibilities for determining the impact of temperature on drug stability are as follows:
- Quality Control Team: To conduct stability testing at various temperature conditions as per the protocol and document results.
- R&D Team: To design the temperature stability study protocol and provide necessary support.
- Regulatory Affairs Team: To ensure the study meets all relevant regulatory requirements.
- Stability Study Coordinator: To manage testing schedules, sample management, and data analysis.
4) Procedure
The detailed stepwise procedure for determining the impact of temperature on drug stability is outlined below:
- Preparation of Stability Study Protocol:
- 4.1 Define the purpose, scope, and objective of the temperature stability testing.
- 4.2 Identify the drug substance or product and the critical quality attributes (CQAs) to be monitored.
- 4.3 Determine the temperature conditions to be tested (e.g., 25°C, 30°C, 40°C, and 50°C).
- 4.4 Establish the time points for testing at each temperature condition.
- 4.5 Develop a protocol outlining the procedures, equipment, and materials required for testing.
- Sample Preparation and Storage:
- 4.6 Select representative samples of the drug product for testing.
- 4.7 Prepare and package samples in their final storage configuration.
- 4.8 Store samples under specified temperature conditions in stability chambers.
- Testing and Monitoring:
- 4.9 Retrieve samples at specified time points and perform the required tests (e.g., assay, degradation products, dissolution).
- 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 due to temperature variations.
- 4.13 Determine the impact of temperature on the stability of the drug product.
- 4.14 Document any significant findings or trends in the data.
- Documentation and Reporting:
- 4.15 Compile a comprehensive temperature 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 temperature stability testing 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 of Technical Requirements for Pharmaceuticals for Human Use
6) Documents, if any
- Temperature 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
8) SOP Version
Version 1.0