Q10: Pharmaceutical Quality System

Regulatory Resource: Q10: Pharmaceutical Quality System

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in June 2008
This guideline applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.
The elements of Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognizing the differences among, and the different goals of each stage.

Download Document: Q10: Pharmaceutical Quality System

0.42 Megabytes