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SOP for Conducting In-Use Stability Testing

Procedure for Performing In-Use Stability Testing of Drug Products

1) Purpose

The purpose of this SOP is to provide a standardized procedure for conducting in-use stability testing of drug products to evaluate their stability during the period of use once the primary container is opened.

2) Scope

This SOP applies to all drug products that require in-use stability testing to determine their stability during the period of use. It is relevant for personnel in quality control, research and development, and regulatory affairs departments.

3) Responsibilities

The responsibilities for conducting in-use stability testing are as follows:

Quality Control Team: To perform

in-use stability tests as per the protocol and document results.

R&D Team: To design the in-use stability study protocol and provide technical support.

Regulatory Affairs Team: To ensure compliance with regulatory guidelines during in-use stability testing.

Stability Study Coordinator: To manage testing schedules, sample management, and data analysis.

4) Procedure

The detailed stepwise procedure for conducting in-use stability testing is outlined below:

Preparation of In-Use Stability Study Protocol:

4.1 Define the purpose, scope, and objective of the in-use stability study.
4.2 Identify the drug product and critical quality attributes (CQAs) to be monitored (e.g., potency, degradation products, microbial stability).
4.3 Determine the storage conditions during the in-use period (e.g., room temperature, refrigerated).
4.4 Establish the time points for testing during the in-use period (e.g., 0, 1, 7, 14 days after opening).
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 and open them at the start of the in-use period.
4.8 Store samples under specified conditions for the duration of the in-use period.

Testing and Monitoring:

4.9 Retrieve samples at specified time points and perform the required tests (e.g., assay, degradation products, microbial testing).
4.10 Record all test results in an in-use 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 during the in-use period.
4.13 Determine the impact of the in-use 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 in-use 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 in-use 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

In-Use Stability Study Protocol
In-Use Stability Testing Log Sheets
In-Use 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