SOP for Conducting Stability Studies for Intrathecal Drugs

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

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.
Development of Stability Study Protocol
1. Draft a protocol that includes storage conditions, test intervals,
  “Unlock the Secrets of Drug Stability: Essential Guide for Pharmaceutical Scientists to Ensure Safe and Effective Medications”
  and analytical methods (e.g., sterility testing, pyrogenicity testing, potency assays).
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).
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.
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