Standard Operating Procedure for Stability Testing of Drugs in Multi-Dose Containers

1) Purpose

This SOP outlines the procedure for conducting stability studies on drugs stored in multi-dose containers to ensure their quality, potency, and sterility are maintained throughout the product’s shelf life.

2) Scope

This SOP applies to all multi-dose container 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 tests, including sterility, preservative effectiveness, and physical integrity.
• Quality Assurance (QA) Team: Reviews and approves protocols and ensures compliance with regulatory guidelines.
• Production Team: Provides necessary samples and maintains documentation of production records.

4) Procedure

1. Sample Collection and Preparation
   1. Collect representative samples from production batches of multi-dose container drugs.
   2. Store samples under recommended conditions until stability testing begins.
2. Development of Stability Study Protocol
   1. Draft a protocol detailing storage conditions, test intervals,
      

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      and analytical methods (e.g., sterility testing, preservative effectiveness testing).
   2. Submit the protocol for approval by the QA and Regulatory Affairs teams.
3. Conducting the Stability Study
   1. Store samples in stability chambers under controlled conditions (e.g., 25°C/60% RH, 30°C/75% RH).
   2. Perform tests at each interval to assess sterility, potency, and preservative effectiveness.
   3. Document all observations, test results, and any deviations from the protocol.
4. Data Analysis and Reporting
   1. Analyze stability data to determine if the multi-dose container 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: Stability Testing of Drug Substances and Drug Products

8) SOP Version

Version 1.0