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SOP for Determining the Impact of Temperature on Drug Stability

Procedure for Assessing Temperature Effects on Drug Stability

1) Purpose

The purpose of this SOP is to provide a standardized procedure for assessing the impact of temperature on the stability of drug substances and products to ensure they maintain their intended quality, safety, and efficacy.

2) Scope

This SOP applies to all drug substances and products that require evaluation of temperature effects on their stability. It is relevant for personnel in quality control, research and development, and regulatory affairs departments.

3) Responsibilities

The responsibilities for assessing the impact of temperature on drug stability are as

follows:

Quality Control Team: To perform temperature stability tests as per the protocol and document results.
R&D Team: To design the temperature stability study protocol and provide technical support.
Regulatory Affairs Team: To ensure compliance with regulatory guidelines during temperature stability testing.
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Study Coordinator: To manage testing schedules, sample management, and data analysis.

4) Procedure

The detailed stepwise procedure for assessing the impact of temperature on drug stability is outlined below:

Preparation of Temperature Stability Study Protocol:

4.1 Define the purpose, scope, and objective of the temperature stability study.
4.2 Identify the drug substance or product and critical quality attributes (CQAs) to be monitored (e.g., potency, degradation products, solubility).
4.3 Determine the temperature conditions to be tested (e.g., 25°C, 40°C, 60°C).
4.4 Establish the time points for testing at each temperature 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 Testing:

4.6 Prepare samples of the drug substance or product for each temperature condition.
4.7 Store samples at the specified temperature conditions in stability chambers or other controlled environments.
4.8 Retrieve samples at specified time points and perform the required tests (e.g., assay, degradation products, solubility).

Data Analysis and Interpretation:

4.9 Analyze the stability data to identify any trends or deviations caused by temperature variations.
4.10 Determine the optimal temperature conditions for the stability of the drug substance or product.
4.11 Document any significant findings or trends in the data.

Documentation and Reporting:

4.12 Compile a comprehensive temperature stability study report including objectives, methods, results, and conclusions.
4.13 Ensure the report is reviewed and approved by relevant stakeholders.
4.14 Submit the report to regulatory bodies or internal stakeholders as required.

Review and Update:

4.15 Regularly review the temperature stability study protocol and update it based on new data or regulatory changes.
4.16 Archive the approved protocol and report in a controlled document management system.

5) Abbreviations, if any

CQA: Critical Quality Attribute

6) Documents, if any

Temperature Stability Study Protocol
Temperature Stability Testing Log Sheets
Temperature 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