SOP for Performing Stability Studies for Radiopharmaceuticals

Procedure for Conducting Stability Studies on Radiopharmaceuticals

1) Purpose

The purpose of this SOP is to provide a standardized procedure for conducting stability studies on radiopharmaceuticals to evaluate their shelf life, safety, and efficacy under various environmental conditions such as temperature, radiation exposure, and light.

2) Scope

This SOP applies to all radiopharmaceuticals, including diagnostic and therapeutic agents, that require 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 conducting stability studies for radiopharmaceuticals are as

follows:

Quality Control Team: To conduct stability tests as per the protocol and document results.
R&D Team: To design the stability study protocol and provide technical support throughout the study.
Regulatory Affairs Team: To ensure compliance with regulatory guidelines specific to radiopharmaceuticals during stability testing.
Stability Study Coordinator:
Formulation Characterization and Stability of Protein Drugs
To oversee testing schedules, sample management, and data analysis.

4) Procedure

The detailed stepwise procedure for conducting stability studies for radiopharmaceuticals is outlined below:

Preparation of Stability Study Protocol:

4.1 Define the purpose, scope, and objectives of the stability study for radiopharmaceuticals.
4.2 Identify the radiopharmaceutical product and critical quality attributes (CQAs) to be monitored (e.g., radiochemical purity, sterility, potency).
4.3 Determine the storage conditions to be tested (e.g., room temperature, refrigerated, shielded from radiation).
4.4 Establish the time points for testing at each storage condition (e.g., 0, 1, 3, 6, 12 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 radiopharmaceutical product for testing.
4.7 Package and label samples appropriately to maintain the integrity and safety of the product.
4.8 Store samples under specified conditions in radiation-shielded areas or other controlled environments.

Testing and Monitoring:

4.9 Retrieve samples at predefined time points and perform required tests (e.g., radiochemical purity, sterility, potency).
4.10 Record all test results in a stability testing log sheet.
4.11 Compare 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 radiopharmaceutical 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

6) Documents, if any

Radiopharmaceutical 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
USP General Chapter <821>: Radioactivity

8) SOP Version

Version 1.0