Quality By Design Resources

Tripartate Guidelines

The International Conference on Harmonization (ICH) has released Tripartate Guidelines for the implementation of Quality by Design in the pharmaceutical industry, and were developed in consultation with regulatory authorities from the United States, Europe and Japan.  The relevant guidelines can be found below:

Regulatory Agencies

Regulatory agencies have provided various pieces of guidance to aid implementation of Quality by Design within the pharmaceutical industry.  Below is a sampling of various key guidances, some of which were developed jointly between more than one agency (e.g., FDA and EMA).

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