StabilityStudies.in

SOP for Performing Stability Testing for Complex Drug Products

Standard Operating Procedure for Stability Testing of Complex Drug Products

1) Purpose

The purpose of this SOP is to provide a standardized procedure for performing stability testing on complex drug products, such as combination drugs, multi-layered tablets, and nanoparticles, to ensure they maintain their safety, efficacy, and quality throughout their shelf life.

2) Scope

This SOP applies to all complex drug 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 testing using appropriate analytical methods tailored

to the specific complexity of the product.

Quality Assurance (QA) Team: Reviews and approves protocols and ensures compliance with regulatory standards.

Production Team: Provides samples and maintains comprehensive production records.

4) Procedure

Sample Preparation
1. Collect representative samples from batches of complex drug products.
2. Store
  “Unveiling the Untold: Innovatively Reliable HPLC Methods for Drug Analysis Ensuring Stability and Quality Assurance”
  samples under recommended conditions until stability testing commences.
Development of Stability Study Protocol
1. Draft a protocol that outlines the storage conditions, test intervals, and analytical methods (e.g., particle size analysis, release rate, impurity profiling).
2. Submit the protocol for review and approval to the QA and Regulatory Affairs teams.
Conducting the Stability Study
1. Store samples in designated stability chambers under specified conditions (e.g., 25°C/60% RH, 40°C/75% RH).
2. Perform tests at each interval to evaluate the stability parameters specific to the complex drug product.
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 complex drug product meets predefined 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
FDA Guidance for Industry: Quality Considerations for Continuous Manufacturing

8) SOP Version

Version 1.0