StabilityStudies.in

SOP for Performing Stability Studies for Freeze-Dried Products

Standard Operating Procedure for Stability Testing of Freeze-Dried (Lyophilized) Products

1) Purpose

The purpose of this SOP is to outline the procedure for performing stability studies on freeze-dried products to ensure that they maintain their potency, purity, and efficacy throughout their shelf life.

2) Scope

This SOP applies to all freeze-dried products manufactured, tested, or stored 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 stability tests, including moisture content, potency, and sterility tests.
Quality Assurance (QA) Team: Reviews and approves protocols and final

reports.

Production Team: Provides samples and maintains documentation of production records.

4) Procedure

Sample Collection and Preparation
1. Collect representative samples of freeze-dried products from production batches.
2. Store samples under recommended storage conditions until stability testing begins.
Development of Stability Study Protocol
1. Draft a protocol
  “Unveiling the Viability of Veterinary Drugs: In-depth Analysis and Crucial Stability Studies for Animal Health Excellence!”
  detailing storage conditions, test intervals, and analytical methods (e.g., Karl Fischer titration for moisture content).
2. Submit the protocol for approval to the QA and Regulatory Affairs teams.
Conducting the Stability Study
1. Store samples in stability chambers under defined conditions (e.g., 25°C/60% RH, 40°C/75% RH).
2. Perform analytical tests at each interval to assess moisture content, potency, and sterility.
3. Document all test results, observations, and any deviations from the protocol.
Data Analysis and Reporting
1. Analyze the stability data to determine if the freeze-dried product meets the 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 <696>: Freeze Drying / Lyophilization of Parenterals

8) SOP Version

Version 1.0