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SOP for Performing Humidity Chamber Studies for Drug Products

Procedure for Conducting Humidity Chamber Studies on Drug Products

1) Purpose

The purpose of this SOP is to provide a standardized procedure for performing humidity chamber studies to evaluate the stability of drug products under various humidity conditions.

2) Scope

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

3) Responsibilities

The responsibilities for conducting humidity chamber studies are as follows:

Quality Control Team: To perform the

humidity tests as per the protocol and document results.

R&D Team: To design the humidity study protocol and provide necessary support.

Regulatory Affairs Team: To ensure compliance with regulatory guidelines during humidity testing.

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

4) Procedure

The detailed stepwise procedure for conducting humidity chamber studies for drug products is outlined below:

Preparation of Humidity Study Protocol:

4.1 Define the purpose, scope, and objective of the humidity chamber studies.
4.2 Identify the drug product and the critical quality attributes (CQAs) to be monitored.
4.3 Determine the humidity conditions to be tested (e.g., 60% RH, 75% RH, 90% RH).
4.4 Establish the time points for testing under each humidity condition.
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.
4.8 Store samples under specified humidity conditions in stability chambers.

Testing and Monitoring:

4.9 Retrieve samples at specified time points and perform the required tests (e.g., assay, degradation products, dissolution).
4.10 Record all test results in a humidity 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 due to humidity variations.
4.13 Determine the impact of humidity 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 humidity 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 humidity 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
RH: Relative Humidity

6) Documents, if any

Humidity Study Protocol
Humidity Testing Log Sheets
Humidity Study Report Template

7) Reference, if any

ICH Q1A(R2): Stability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0