The revolution in scientific knowledge that is bringing hope to patients with devastating diseases is also setting the stage for modernizing our approach to specifications and process control. Updating our approach to specification setting will accelerate the delivery of breakthroughs to patients.
New requirements for control of elemental impurities went into effect at the beginning of 2018, replacing the longstanding requirements for heavy metals. Elemental impurities guidances are based on modern safety considerations specific to the elements identified.
Recent revisions to the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice, as outlined in ICH E6 (R2), have provided an impetus for sponsors to reevaluate their oversight and quality management processes throughout the clinical development process.
Quality risk management (QRM) is not a concept to be applied in a vacuum. Rather, it is a discipline that provides the most value when used throughout the product life cycle.
Many organizations with very robust QMSs routinely find themselves in a state of disarray and facing compliance issues when key members of the quality leadership team leave the organization.
In his recent column, Jim Kremidas, executive director of the Association of Clinical Research Professionals, challenged the industry to address the need to raise the standards of professionalism of the clinical research workforce To say that Jim has been obsessed about helping the industry understand the impact that variance in personnel performance has on the quality conduct of clinical research and ultimately, the patient experience, would be an understatement.