StabilityStudies.in

SOP for Performing Stability Studies for Controlled-Temperature Products

Standard Operating Procedure for Stability Testing of Controlled-Temperature Drug Products

1) Purpose

The purpose of this SOP is to provide a standard procedure for conducting stability studies on drug products that require controlled-temperature storage conditions, ensuring they maintain their quality, safety, and efficacy throughout their shelf life.

2) Scope

This SOP applies to all drug products that require controlled-temperature storage, such as those stored at refrigerated or frozen conditions. It is relevant to the departments involved in manufacturing, quality control, quality assurance, and regulatory compliance.

3) Responsibilities

Quality Control (QC) Team: Conducts stability testing and documents results.
Quality Assurance (QA)

Team: Ensures compliance with this SOP and regulatory guidelines.

Production Team: Provides the required samples for testing and maintains batch records.

4) Procedure

Sample Preparation
1. Identify the drug products requiring controlled-temperature storage.
2. Collect representative samples from production batches.
Stability Study Protocol Development
1. Draft a
  “Unlock the Secrets to Long-lasting Medicine: Ensuring the Stability of Drugs and Dosage Forms for Optimum Effectiveness!”
  stability study protocol outlining storage conditions (e.g., 2-8°C, -20°C), test intervals, and analytical methods.
2. Submit the protocol for approval by the QA and Regulatory Affairs teams.
Execution of Stability Study
1. Store samples in controlled-temperature chambers at specified conditions.
2. Perform analytical tests at each interval to assess stability parameters, including potency, purity, and appearance.
3. Record and document all findings, test results, and deviations from the protocol.
Data Analysis and Reporting
1. Analyze data to determine if the product remains stable under the specified controlled-temperature conditions.
2. Prepare a comprehensive report and submit it to the QA team for review and approval.

5) Abbreviations, if any

QC: Quality Control
QA: Quality Assurance

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
WHO Technical Report Series No. 953: Annex 2, Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products

8) SOP Version

Version 1.0