Articles by Frithjof Holtz - Pharmaceutical Technology

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Articles by Frithjof Holtz

A Practical Approach of Implementing GMP for Excipients

The authors discuss ways to apply ICH Q9.
Sep 1, 2014

Using a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.

Supplier Qualification

A comparison of comprehensive third-party excipient GMP audit programs.
Oct 2, 2012

This article provides a comparison of Rx-360, EXCiPACT and IPEA, available to pharmaceutical manufacturers for the purpose of auditing excipient suppliers and ensuring drug efficacy and patient safety.

A Supplier's Role in Ensuring and Improving Excipient Quality

Excipients are the hidden champions of drug development—no API works consistently without the right excipient. Pharmaceutical excipients, however, require stringent quality management. This article discusses how the supplier of pharmaceutical raw materials should take a central role in ensuring excipient quality.
Sep 1, 2011

Excipients are the hidden champions of drug development—no API works consistently without the right excipient. Pharmaceutical excipients, however, require stringent quality management. This article discusses how the supplier of pharmaceutical raw materials should take a central role in ensuring excipient quality.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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