GMP NEWS 2004

FDA White Paper: Innovation and Continuous Improvement in Pharmaceutical Manufacturing

Besides the FDA Guidance for Industry on PAT (Process Analytical Technology) dated September 2004 (GMP News from October 2004) FDA published at the same time a so-called White Paper with the title "Innovation and Continuous Improvement in Pharmaceutical Manufacturing". This publication is a summarizing report of the FDA PAT Team and the Manufacturing Science Working Group, in which it is described what has so far been reached and which steps will next be suggested to achieve the desired state of pharmaceutical manufacturing. The entire PAT initiative has a key function in the primary effort of the FDA to completely re-define the pharmaceutical GMP rules for the 21st century.

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New Guideline by the Global Harmonization Task Force (GHTF) on Risk Analysis

With the start of the new FDA initiative "Pharmaceutical cGMPs for the 21st century" the FDA has also introduced a risk-based approach. From now on, almost every pharmaceutical activity shall be in the focus of this risk-based approach. The aim is to check the implementation of the risk-based approach within the framework of the FDA inspections in the future. The FDA has not yet given any concrete statements on how to implement the risk-based approach.

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