GXP is a collective term for Good Manufacturing Practice, Good Laboratory Practice, Good Documentation Practice and any other “Practice” that contributes to the manufacture of high quality clinical material suitable for human use. Review the materials in the course content area for the week.

GXP is a collective term for Good Manufacturing Practice, Good Laboratory Practice, Good Documentation Practice and any other “Practice” that contributes to the manufacture of high quality clinical material suitable for human use. Review the materials in the course content area for the week.

A. Importation and use of contaminated raw material from a foreign source was linked to the death of US citizens. (See http://www.washingtonpost.com/wp-dyn/content/article/2008/04/08/AR2008040803032.html)

There have also been reports of contaminated pet treats suspected to have originated from external sources:

http://www.wjla.com/articles/2014/05/contaminated-jerky-pet-treats-linked-to-at-least-1-000-canine-deaths-many-more-illnesses-103320.html

The case has been made that these incidents might be avoided by having US FDA staff inspect foreign manufacturing facilities. The obvious problem with this is the prohibitive cost and resource associated with this approach.

1. Where does this leave the average consumer? What do you think should be done?

2. Take a look at the GMP for phase I guidance document in the course content area (again). Based on this document, do you feel that material used for phase I clinical trials are less safe than materials used for later stages (phase II, III)?

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