Procedure for Performing Stability Studies for Biologic Drug Products

1) Purpose

The purpose of this SOP is to provide a standardized procedure for conducting stability studies on biologic drug products to evaluate their shelf life and storage conditions under various environmental factors such as temperature, humidity, and light.

2) Scope

This SOP applies to all biologic drug products that require stability testing to determine their shelf life and storage requirements. It is relevant for personnel in quality control, research and development, and regulatory affairs departments.

3) Responsibilities

The responsibilities for conducting stability studies for biologics 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 and provide technical support.
• Regulatory Affairs Team: To ensure compliance with regulatory 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 for biologic drug products is outlined below:

1. Preparation of Stability Study Protocol:
1. 4.1 Define the purpose, scope, and objective of the stability study for biologics.
2. 4.2 Identify the biologic product and critical quality attributes (CQAs) to be monitored (e.g., potency, purity, degradation products).
3. 4.3 Determine the storage conditions to be tested (e.g., refrigerated, frozen, room temperature).
4. 4.4 Establish the time points for testing at each storage condition (e.g., 0, 3, 6, 12, 24 months).
5. 4.5 Develop a protocol outlining procedures, equipment, and materials required for testing.
2. Sample Preparation and Storage:
1. 4.6 Select representative samples of the biologic product for testing.
2. 4.7 Prepare and package samples in their final storage configuration.
3. 4.8 Store samples under specified conditions in stability chambers or other controlled environments.
3. Testing and Monitoring:
1. 4.9 Retrieve samples at specified time points and perform the required tests (e.g., potency, degradation products, sterility).
2. 4.10 Record all test results in a stability testing log sheet.
3. 4.11 Evaluate the results against predefined acceptance criteria.
4. Data Analysis and Interpretation:
1. 4.12 Analyze the stability data to identify any trends or deviations in the quality attributes.
2. 4.13 Determine the impact of different storage conditions on the stability of the biologic product.
3. 4.14 Document any significant findings or trends in the data.
5. Documentation and Reporting:
1. 4.15 Compile a comprehensive stability study report including objectives, methods, results, and conclusions.
2. 4.16 Ensure the report is reviewed and approved by relevant stakeholders.
3. 4.17 Submit the report to regulatory bodies or internal stakeholders as required.
6. Review and Update:
1. 4.18 Regularly review the stability study protocol and update it based on new data or regulatory changes.
2. 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

• Biologic Stability Study Protocol
• Stability Testing Log Sheets
• Stability Study Report Template

7) Reference, if any

• ICH Q5C: Stability Testing of Biotechnological/Biological Products

8) SOP Version

Version 1.0