Procedure for Conducting Long-Term Stability Testing of Drug Products
1) Purpose
The purpose of this SOP is to provide a standardized procedure for conducting long-term stability testing of drug products to evaluate their shelf life and storage conditions under normal environmental conditions.
2) Scope
This SOP applies to all drug products that require long-term stability testing to determine their shelf life and appropriate storage conditions. It is relevant for personnel in quality control, research and development, and regulatory affairs departments.
3) Responsibilities
The responsibilities for performing long-term stability testing are as follows:
- Quality Control Team: To perform stability tests as
per the protocol and document results.
R&D Team: To design the long-term stability study protocol and provide technical support.
Regulatory Affairs Team: To ensure compliance with regulatory guidelines during long-term stability testing.
Stability Study Coordinator: To manage testing schedules, sample management, and data analysis.
procedure for conducting long-term stability testing is outlined below:
4) Procedure
The detailed stepwise
- Preparation of Long-Term Stability Study Protocol:
- 4.1 Define the purpose, scope, and objective of the long-term stability study.
- 4.2 Identify the drug product and critical quality attributes (CQAs) to be monitored (e.g., potency, degradation products, dissolution).
- 4.3 Determine the storage conditions to be tested (e.g., 25°C/60% RH).
- 4.4 Establish the time points for testing (e.g., 0, 6, 12, 24, 36 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 product for testing.
- 4.7 Prepare and package samples in their final storage configuration.
- 4.8 Store samples under specified long-term 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).
- 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 long-term storage conditions 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 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 long-term 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
- RH: Relative Humidity
6) Documents, if any
- Long-Term 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