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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PDF Edition — $397
Who Will Benefit
Commissioning and Qualification
Manufacturing and Operations
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