StabilityStudies.in

SOP for Conducting Stability Studies for Drug-Eluting Stents

Standard Operating Procedure for Stability Testing of Drug-Coated Stents

1) Purpose

This SOP provides a standardized approach for conducting stability studies on drug-eluting stents to ensure the drug maintains its intended release profile, safety, and efficacy throughout the product’s shelf life. These studies are crucial for verifying that the stent’s drug coating remains stable under various conditions.

2) Scope

This SOP applies to all drug-eluting stents manufactured, stored, or tested within the facility. It is relevant to departments involved in production, quality control, quality assurance, and regulatory compliance.

3) Responsibilities

Quality Control (QC) Team: Conducts analytical tests, including in

vitro drug release studies, mechanical integrity assessments, and chemical stability tests.

Quality Assurance (QA) Team: Reviews and approves stability study protocols and reports, ensuring regulatory compliance.

Production Team: Provides the necessary samples and maintains accurate production batch records.

4) Procedure

Sample Preparation
1. Collect
  “The Secrets of Stability Studies: Statistical Design and Analysis Tools Unveiled for Reliable and Long-lasting Products!”
  representative samples of drug-eluting stents from each production batch.
2. Store samples under appropriate conditions until stability testing is initiated.
Development of Stability Study Protocol
1. Draft a protocol that outlines storage conditions (e.g., 25°C/60% RH), test intervals, and analytical methods (e.g., in vitro release testing, sterility testing).
2. Submit the protocol to the QA and Regulatory Affairs teams for review and approval.
Conducting the Stability Study
1. Store samples in designated stability chambers under controlled conditions as specified in the protocol.
2. Perform tests at each interval to assess drug release, mechanical properties, and sterility of the stents.
3. Document all test results, observations, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze stability data to determine whether the drug-eluting stent meets predefined acceptance criteria over time.
2. Prepare a comprehensive stability study report and submit it to the QA team for final review and approval.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance
RH: Relative Humidity

6) Documents, if any

Stability Study Protocol
Analytical Test Reports
Stability Study Report

7) Reference, if any

ISO 25539-2: Cardiovascular Implants – Endovascular Devices – Part 2: Vascular Stents
FDA Guidance for Industry: Coronary Drug-Eluting Stents – Nonclinical and Clinical Studies

8) SOP Version

Version 1.1