SOP for Performing Stability Studies for Modified Release Formulations

Guidelines for Stability Testing of Modified Release Formulations

1) Purpose

The purpose of this SOP is to provide a standardized approach for conducting stability studies for modified release formulations. These formulations are designed to release the active ingredient over a specific period, and their stability must be evaluated to ensure consistent performance throughout the product’s shelf life.

2) Scope

This SOP applies to all modified release formulations, including sustained-release, extended-release, and delayed-release products, produced or tested by the organization. It is intended for use by personnel involved in formulation development, quality control, and regulatory affairs.

3) Responsibilities

Formulation

Scientist: Responsible for designing the stability study and selecting appropriate testing parameters.

Analytical Team: Responsible for conducting stability tests according to the approved protocol.

QA Team: Responsible for reviewing data, approving the study protocol, and ensuring regulatory compliance.

4) Procedure

4.1 Study Design:

Identify critical attributes to be evaluated,
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such as dissolution rate, potency, and content uniformity.
Select appropriate storage conditions and define the time points for testing.
Prepare a study protocol detailing the analytical methods and acceptance criteria.

4.2 Sample Preparation:

Prepare samples from multiple production batches to ensure representativeness.
Label samples accurately with storage conditions, batch numbers, and testing intervals.
Store samples in stability chambers under specified conditions.

4.3 Testing Schedule:

Conduct initial testing to establish baseline data for critical attributes.
Perform follow-up testing at predetermined intervals to monitor changes over time.
Document and analyze data to detect any trends or deviations from the acceptance criteria.

4.4 Data Analysis and Reporting:

Compile data and assess whether the product meets the defined criteria for each time point.
Prepare a report summarizing the stability study findings, conclusions, and recommended storage conditions.
Submit the report for QA review and archiving.

5) Abbreviations, if any

QA: Quality Assurance

6) Documents, if any

Modified Release Stability Protocol: Document outlining the study plan.

Analytical Data Records: Data sheets for all tests performed.

7) Reference, if any

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

8) SOP Version

Version 1.0