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
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, 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