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Is Quality by Design just for Big Pharma? By Dr Peter Calcott

This article was originally published on 5 June 2012 for the Master Control website www.mastercontrol.com and its publication GxP Lifeline …

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New EU GDP Guidelines (2013/C 68/01), versus, The Consultation Paper: radically different or a few minor tweaks?

An Analysis By Sanjay Nadarajah 7th March 2013, is a landmark date in the evolution of Good Distribution Practice. As …

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An Audio introduction to the New Guidelines by Sanjay Nadarajah

This audio presentation provides us with a brief introduction to the New Guidelines. This clip discusses the background for change and gives …

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Hot off the Press: the NEW EU GDP Guidelines (2013/C 68/01) have now been published! By Sanjay Nadarajah

The highly anticipated Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) …

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FDA Process Validation Guidance has celebrated its first birthday! How is the one year old doing? By Dr Peter Calcott

This article was originally published on 30 March 2012, on the Pharmaceutical Processing website. To see the original please click …

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Good Distribution Practices – Warehouse Operations – Temperature Mapping (Ambient and Cold Chain)

What is Temperature Mapping? An analysis of the temperature gradient across the medicinal product storage areas. Why Do You need …

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