StabilityStudies.in

Standard Operating Procedure for Stability Testing of Single-Dose Vials

1) Purpose

The purpose of this SOP is to establish a procedure for conducting stability studies on single-dose vials, ensuring that the drug product maintains its quality, potency, and sterility throughout its shelf life.

2) Scope

This SOP applies to all single-dose vial drug products manufactured, tested, or stored within the facility. It covers the responsibilities of departments involved in production, quality control, quality assurance, and regulatory compliance.

3) Responsibilities

• Quality Control (QC) Team: Conducts stability tests, including sterility, potency, and physical examination.
• Quality Assurance (QA) Team: Reviews and approves the stability study protocol and final reports.
• Production Team: Provides necessary samples and maintains records of batch production.

4) Procedure

1. Sample Collection and Preparation
   1. Collect representative samples from single-dose vial production batches.
   2. Ensure samples are stored under the appropriate conditions until the stability study begins.
2. Development of Stability Study Protocol
   1. Draft
      

      “Unveiling the Secret of Drug Stability: Exploring Chemical Kinetics to Ensure Long-lasting Effectiveness and Safety”

      a protocol outlining the storage conditions, testing intervals, and analytical methods (e.g., sterility 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 designated stability chambers under controlled conditions (e.g., 25°C/60% RH).
   2. Perform analytical tests at each specified interval to assess sterility, potency, and physical characteristics.
   3. Document all test results, observations, and any deviations from the protocol.
4. Data Analysis and Reporting
   1. Analyze the stability data to determine if the single-dose vial product meets the 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 <797>: Pharmaceutical Compounding – Sterile Preparations

8) SOP Version

Version 1.0

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