The State of Pharmaceutical Quality FY21
Introduction On August 25th, the Office of Pharmaceutical Quality (OPQ), part of the FDA’s Center for Drug Evaluation and Research (CDER) released its fourth annual Report on the State of Pharmaceutical Quality, covering fiscal year 2021. Generally speaking, the OPQ is tasked with ensuring that legally marketed drugs in the US are safe, effective, and […]
IATF Updates Rules 5th Edition FAQ in Response to Ongoing Semiconductor Shortage
On April 7th, 2022, IATF reported that the organization had approved Stakeholder Communique SC-2022-006 Rules 5th Edition FAQ and Sanctioned Interpretations. Of special note is the update to FAQ 8, which poses the question as to whether additional audit time should be added if poor OEM scorecard performance is caused by the ongoing semiconductor shortage […]