Getting Ready for Risk-Based GMPs

Patrick Clinton;

Publication

Article

April 15, 2003

BioPharm International

BioPharm International-04-01-2003

Volume16

Issue 4

Getting Ready for Risk-Based GMPs

Author(s):

Patrick Clinton

by Patrick Clinton, BioPharm International As FDA moves toward a new vision of GMP regulations, BioPharm International asked industry experts some key quextions: What form will risk-based GMPs take? What are the benefits and costs for biotech? Will the change really encourage innovation? And, most important, can FDA leaders get field inspectors to buy into the new approach?

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Articles in this issue

Virus Inactivation in the 1990s and into the 21st Century

Using Peptide Maps as Identity and Purity Tests for Lot Release Testing of Recombinant Therapeutic Proteins

Getting Ready for Risk-Based GMPs

GMP Issues: Breaking Ground

Guest Editorial: Benchmarking Biotech

Optimized Nutrient Additives for Fed-Batch Cultures

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