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SOP for Performing Real-Time Stability Testing for Drug Substances

Standard Procedure for Conducting Real-Time Stability Testing on Drug Substances

1) Purpose

The purpose of this SOP is to provide a structured procedure for conducting real-time stability testing of drug substances to ensure their safety, efficacy, and quality throughout their shelf life under recommended storage conditions.

2) Scope

This SOP applies to all drug substances that require real-time stability testing to determine their shelf life and establish suitable storage conditions. It is relevant for all personnel in quality control, research and development, and regulatory affairs departments.

3) Responsibilities

The responsibilities for conducting real-time stability testing are

as follows:

Quality Control Team: To conduct real-time stability testing as per the protocol and document results.
R&D Team: To design the stability study and provide necessary technical support.
Regulatory Affairs Team: To ensure the study meets regulatory requirements.
Stability Study Coordinator: To
“Ensuring Pharmaceutical Purity and Potency: Unveiling Effective Techniques for Reliable Stability Testing and Quality Control”
manage the testing schedule, sample management, and data analysis.

4) Procedure

The detailed stepwise procedure for performing real-time stability testing is outlined below:

Preparation of Stability Study Protocol:

4.1 Define the purpose, scope, and objective of the real-time stability testing.
4.2 Identify the drug substance and critical quality attributes (CQAs) to be monitored.
4.3 Determine the storage conditions as per the ICH guidelines (e.g., 25°C ± 2°C and 60% RH ± 5% RH).
4.4 Establish the time points for testing (e.g., 0, 3, 6, 9, 12, 24, 36 months).
4.5 Develop the protocol, outlining procedures, equipment, and materials required for testing.

Sample Preparation and Storage:

4.6 Select representative samples from different batches for testing.
4.7 Prepare and package samples in their final storage configuration.
4.8 Store samples under the specified conditions in a stability chamber.

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 stability testing log sheet.
4.11 Evaluate the results against predefined acceptance criteria.

Data Analysis and Interpretation:

4.12 Analyze the stability data to determine any trends or deviations.
4.13 Calculate the shelf life of the drug substance based on real-time data.
4.14 Assess compliance with regulatory guidelines and standards.

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 authorities.
4.17 Submit the report to regulatory bodies or internal stakeholders as required.

Review and Update:

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

5) Abbreviations, if any

CQA: Critical Quality Attribute
RH: Relative Humidity
ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

6) Documents, if any

Real-Time 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

8) SOP Version

Version 1.0