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 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).
Case studies are publicly available that provide excellent demonstration of Quality by Design tools and principles. A sampling of these case studies can be found at the links below:
Miscellaneous on-line resources that may be of assistance in Pharmaceutical Quality by Design efforts: