Rx-360 - A non-profit to help secure the supply chain (podcast)

Updated July 29, 2020

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Rx-360 - About Us

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Learn about Rx-360. Listen to this Pharmaceutical Technology podcast (~ 11 mins), Podcast: A Look at Rx-360. Here's how Pharmaceutical Technology describes this podcast:

Join Angie Drakulich, Managing Editor of Pharmaceutical Technology, as she speaks with Martin Van Trieste, Vice-President of Quality for Amgen and Interim Director of Rx-360, a new nonprofit international pharmaceutical consortium, about the need for industry to come together to secure the supply chain. They will explore shared supplier audit models and FDA's take on the consortium's proposals.

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FDA Final Guidance On ICH Q10 - Quality Control System

• FDA cGMP QSR GMP Online Training Courses - by SkillsPlus International Inc.

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If you follow quality issues in the GMP regulated industry space, you'll want to get up to speed on ICH Q10. Here's what the FDA has to say about this new guidance, FDA - Q10 Pharmaceutical Quality System:

This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system. Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model. ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes applicable good manufacturing practice (GMP) regulations, and complements ICH "Q8 Pharmaceutical Development" and ICH "Q9 Quality Risk Management." ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current regional GMP requirements is optional.

In summary, the International Conference on Harmonization's (ICH) Q10 attempts to provide a comprehensive model for an effective quality management system by building upon good manufacturing practices (GMP). 

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