The pharmaceutical industry is still struggling to incorporate the quality risk management principles in the International Council for Harmonization’s Q9 guideline into quality operations, despite the benefits in improving product quality and reducing product defects. Even more troubling is that there is still lingering uncertainty on what QRM is 13 years after ICH Q9 was adopted.
So asserted Ghada Haddad, executive director of the global GMP and compliance auditing organization for Merck & Co. Inc., who spoke at the 2018 Sterile Medicinal Products Manufacturing Conference sponsored by the Parenteral Drug Association on May 14 in Bethesda, Md