Drugmaker’s Guide to ASTM E2500: Best Practices for Increasing Process Efficiency and FDA Compliance

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Drugmaker’s Guide to ASTM E2500
Best Practices for Increasing Process Efficiency and FDA Compliance

The FDA in its GMPs for the 21st Century report states that “The frequency and/or scope of inspections will be reduced for firms that FDA determines have acquired sufficient process understanding and have succeeded in implementing effective quality systems approaches.” This report shows drugmakers how using the ASTM E2500 manufacturing standard can produce the evidence the FDA needs to award that reduced scrutiny.

Implementing E2500 makes both the startup and validation process more efficient by documenting the entire effort — from process development to continuous monitoring — which dovetails with the FDA’s priorities for process validation.

Drugmaker’s Guide to ASTM E2500 explains the principles of ASTM E2500, uses case studies to show how to best implement it and shows how to use the standard to fulfill FDA expectations. You will learn:

  • How the standard helps identify critical areas and verify that they are working properly

  • How to meld Good Manufacturing Practices with Good Engineering Practices so quality and technical departments can work effectively together

  • How to develop Commissioning Test Plans

  • How to present key data to FDA investigators

Order your copy of Drugmaker’s Guide to ASTM E2500 and use ASTM E2500 to increase production efficiency and present a positive picture to the FDA.

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Available Format

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Who Will Benefit

  • Engineering
  • Project Management
  • Commissioning and Qualification
  • Quality Assurance
  • Regulatory Affairs
  • Manufacturing and Operations

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