Procedure for Evaluating the Effect of Packaging on Drug Stability
1) Purpose
The purpose of this SOP is to provide a standardized procedure for assessing the impact of packaging on the stability of drug products. This evaluation helps in selecting the most suitable packaging materials and configurations to ensure the drug product’s shelf life and quality.
2) Scope
This SOP applies to all drug products that require stability testing to determine the effect of packaging on their shelf life. It is relevant for personnel in quality control, research and development, and regulatory affairs
departments.
3) Responsibilities
The responsibilities for assessing the impact of packaging on drug stability are as follows:
- Quality Control Team: To conduct packaging stability tests as per the protocol and document results.
- R&D Team: To design the packaging stability study protocol and provide technical support.
- Regulatory Affairs Team: To ensure compliance with regulatory guidelines during packaging stability testing.
- Stability Study Coordinator: To manage testing schedules, sample management, and data analysis.
4) Procedure
The detailed stepwise procedure for assessing the impact of packaging on drug stability is outlined below:
- Preparation of Packaging Stability Study Protocol:
- 4.1 Define the purpose, scope, and objective of the packaging stability study.
- 4.2 Identify the drug product and critical quality attributes (CQAs) to be monitored (e.g., potency, degradation products, appearance).
- 4.3 Determine the packaging materials and configurations to be tested (e.g., blisters, bottles, pouches).
- 4.4 Establish the storage conditions to be tested (e.g., temperature, humidity, light exposure).
- 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 Package the samples in different packaging configurations as specified in the protocol.
- 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, moisture content).
- 4.10 Record all test results in a packaging 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 caused by packaging.
- 4.13 Determine the impact of different packaging materials 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 packaging 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 packaging 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
6) Documents, if any
- Packaging Stability Study Protocol
- Packaging Stability Testing Log Sheets
- Packaging 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