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Few things in drugmaking are as challenging as process validation — nor as likely to trip you up with FDA inspectors. Hundreds of individual manufacturing processes to validate. And the most common mistakes occur after the work of validation has taken place: when documenting the work to show that it’s been done.
FDA inspectors examiners are trained to be sticklers, and their mantra: ‘If it isn’t written down, it didn’t happen.’ Now, two experts with decades of production-line experience have teamed to produce the definitive guide to documenting process validation in pharmaceutical manufacturing.
Here’s a step-by-step manual based on real-world examination experience. You’ll discover how to document process validation in a way that’s sure to satisfy — and impress — regulators.
You’ll confront and solve the slipperiest problems, including creating, establishing and organizing:
BONUS feature: Detailed sample documents to adapt to your specific manufacturing situations:
Co-authors Christine Oechslein and Max Lazar are ideal guides to this complex manufacturing and regulatory challenge:
Looking for a plain-English guide to complex technical matters? Need methods to apply consistent standards across multiple manufacturing operations? Want to gain the confidence of inspectors that your operation is qualified to meet high manufacturing standards? Look no further. Documenting Process Validation: A Drugmaker’s Guide is that document.
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