GMP Trends and Analyses!

The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance

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ECA GMP Newsletter

Welcome to the GMP Journal. We inform you about the current GMP trends. Our analyses, interpretations, practical examples and background reports will help you with the EU/FDA compliant GMP implementation in practice.

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GDP Update for 2024/2025

GDP Update for 2024/2025

This article summarizes some highlights in GDP from 2024 and an outlook at 2025. Please read more here

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ICH Q14 and the Paradigm Shift in Pharmaceutical Analytics

ICH Q14 and the Paradigm Shift in Pharmaceutical Analytics

Quality-Oriented Method Development in the Age of QbD. Please read more here

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Remote Certification – Take-aways from legal Considerations

Remote Certification – Take-aways from legal Considerations

The risks, responsibilities and opportunities of Single-Use Systems. Please read more here

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Questions and Answers to Cloud Computing in a GxP Environment - Part 4

Questions and Answers to Cloud Computing in a GxP Environment - Part 4

Nine experts from the pharmaceutical industry and regulatory authorities answer frequently asked questions on cloud computing. Please read more here

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Statistical Approach to Aseptic Process Simulation

Statistical Approach to Aseptic Process Simulation

Representativeness and Proactive Alert Limit Setting for Aseptic Interventions. Please read more here

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