StabilityStudies.in

SOP for Conducting Stability Studies for Drug-Eluting Stents

Standard Operating Procedure for Stability Testing of Drug-Eluting Stents

1) Purpose

The purpose of this SOP is to establish a procedure for conducting stability studies for drug-eluting stents, ensuring that the drug component retains its intended release profile and efficacy throughout the shelf life of the device.

2) Scope

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

3) Responsibilities

Quality Control (QC) Team: Conducts analytical tests to evaluate drug release profiles and stability.
Quality Assurance (QA) Team: Reviews

protocols, ensures compliance, and approves final stability reports.

Production Team: Provides samples and ensures proper documentation of production batches.

4) Procedure

Sample Preparation
1. Obtain representative samples of drug-eluting stents from recent production batches.
2. Store samples according to recommended storage conditions until stability testing
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  begins.
Design of Stability Study
1. Prepare a protocol detailing the storage conditions, intervals, and analytical methods (e.g., in vitro drug release testing).
2. Submit the protocol for approval to the QA and Regulatory Affairs teams.
Execution of Stability Study
1. Store samples in designated stability chambers under controlled conditions (e.g., 25°C/60% RH).
2. Perform analytical tests at each specified interval to evaluate drug release profiles, mechanical integrity, and sterility.
3. Document all results, observations, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze the stability data to determine if the drug-eluting stent meets predefined acceptance criteria.
2. Prepare a detailed stability study report and submit it to the QA team for 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 1.0