Technology Introduces a New Normal for Quality Practices
Pharma companies find ways to maintain quality standards, despite pandemic-related restrictions.
The COVID-19 pandemic has posed serious challenges in pharmaceutical supply chain management and quality assurance and control (QA/QC) at a time when budgets and staffing at many companies have been constrained. Identifying the cultural roots of quality problems challenges pharma’s quality leaders to establish a culture of quality. A growing trend is the use of technology to optimize QA/QC.
An Editors’ Series panel discussion—A “New Normal” for Quality Practices—reviews quality and regulatory challenges amid the pandemic, focusing on new technologies such as remote monitoring, risk-based quality management, Annex 1 changes in the European Union, and lessons learned going forward.
The quality practices panel discussion features commentary from Scott Deckebach, MBA, director of compliance, Lachman Consultant Services, Inc.; Marty Lipa, pharmaceutical regulatory science team member and doctoral student at Technological University Dublin, and executive director of knowledge management at Merck and Co., Inc.; and Siegfried Schmitt PhD, vice-president, Parexel, and Pharmaceutical Technology editorial advisor and columnist.
The discussion, moderated by the editors of Pharmaceutical Technology and BioPharm International, was recorded on Nov. 11, 2020, during the 2020 Bio/Pharma Virtual Congress.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
