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Standard Operating Procedure for Stability Testing Following ASEAN Guidelines

1) Purpose

The purpose of this SOP is to establish a standardized approach for conducting stability testing for drug products in compliance with the ASEAN (Association of Southeast Asian Nations) guidelines to ensure their quality, safety, and efficacy.

2) Scope

This SOP applies to all drug substances and products requiring stability testing as per ASEAN guidelines. It is relevant to departments involved in production, quality control, quality assurance, and regulatory affairs.

3) Responsibilities

• Quality Control (QC) Team: Conducts stability testing according to ASEAN guidelines.
• Quality Assurance (QA) Team: Reviews and approves protocols and reports to ensure compliance.
• Regulatory Affairs Team: Ensures stability data meets ASEAN submission requirements.

4) Procedure

1. Preparation of Stability Protocol
   1. Develop a stability study protocol according to ASEAN guidelines, specifying storage conditions (e.g., 30°C/75% RH), test intervals, and analytical methods.
   2. Submit the protocol for
      

      “Mastering Pharmaceutical Stability Testing: Your Complete Guide to Ensuring Long-lasting Quality and Efficacy in Drug Development”

      review and approval to the QA team.
2. Execution of Stability Study
   1. Store samples in stability chambers under specified conditions as per the ASEAN guidelines.
   2. Conduct tests at defined intervals to evaluate stability parameters such as potency, impurity levels, and dissolution rates.
   3. Document all observations, test results, and any deviations from the protocol.
3. Data Analysis and Reporting
   1. Analyze stability data to ensure compliance with ASEAN requirements.
   2. Prepare a stability study report for submission to the relevant regulatory body.

5) Abbreviations, if any

• QC: Quality Control
• QA: Quality Assurance
• ASEAN: Association of Southeast Asian Nations
• RH: Relative Humidity

6) Documents, if any

• Stability Study Protocol
• Analytical Test Reports
• Stability Study Report

7) Reference, if any

• ASEAN Guidelines on Stability Study of Drug Product

8) SOP Version

Version 1.0

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