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SOP for Performing Stability Studies for Sterile Products

Standard Operating Procedure for Stability Testing of Sterile Products

1) Purpose

This SOP outlines a standardized procedure for performing stability studies on sterile drug products to ensure they maintain their sterility, potency, and safety throughout their shelf life.

2) Scope

This SOP applies to all sterile drug products manufactured, tested, or stored within the facility, including injectable, ophthalmic, and inhalation products. It is relevant to departments involved in production, quality control, quality assurance, and regulatory compliance.

3) Responsibilities

Quality Control (QC) Team: Conducts stability testing, including sterility tests, potency assays, and pyrogen testing.
Quality Assurance (QA) Team: Reviews and approves

protocols and ensures compliance with regulatory requirements.

Production Team: Provides necessary samples and maintains proper documentation.

4) Procedure

Sample Preparation
1. Collect representative samples from production batches of sterile products.
2. Store samples under appropriate conditions until stability testing begins.
Development of Stability Study Protocol
1. Prepare
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  a protocol detailing storage conditions, test intervals, and analytical methods (e.g., sterility testing, potency assays).
2. Submit the protocol for review and approval to the QA and Regulatory Affairs teams.
Conducting the Stability Study
1. Store samples in stability chambers under specified conditions (e.g., 25°C/60% RH, 40°C/75% RH).
2. Perform tests at each interval to assess sterility, potency, and pyrogen levels.
3. Document all test results, observations, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze the stability data to ensure the sterile product meets acceptance criteria over time.
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

ICH Q1A(R2): Stability Testing of New Drug Substances and Products
USP General Chapter <71>: Sterility Tests

8) SOP Version

Version 1.0