Standard Operating Procedure for Stability Testing of Intrathecal Drug Products

1) Purpose

This SOP establishes a standardized procedure for conducting stability studies on intrathecal drug products to ensure their sterility, potency, and safety throughout their shelf life.

2) Scope

This SOP applies to all intrathecal 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, including sterility, potency, and pyrogenicity tests.
• Quality Assurance (QA) Team: Reviews and approves protocols and final reports.
• Production Team: Provides necessary samples and maintains proper documentation of production records.

4) Procedure

1. Sample Collection and Preparation
   1. Collect representative samples from each batch of intrathecal drug products.
   2. Ensure samples are stored under appropriate conditions until the stability study begins.
2. Development of Stability Study Protocol
   1. Draft a protocol that includes storage conditions, test intervals, and analytical methods (e.g., sterility testing,
      

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      pyrogenicity testing, potency assays).
   2. Submit the protocol for approval to the QA and Regulatory Affairs teams.
3. Conducting the Stability Study
   1. Store samples in stability chambers under defined conditions (e.g., 25°C/60% RH).
   2. Perform stability tests at each specified interval to assess sterility, potency, and pyrogenicity.
   3. Document all observations, test results, and any deviations from the protocol.
4. Data Analysis and Reporting
   1. Analyze the stability data to ensure the intrathecal drug 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 <151>: Pyrogen Test

8) SOP Version

Version 1.0