While other industries have learned from the principles of quality and statistical control methodology, (bio)pharma has been slow on the uptake. This article proposes tactic designs that utilize collaboration tools to facilitate Kaizen/continuous improvement in quality management systems (QMSs).
A recent U.S. FDA publication entitled The Future of Pharmaceutical Quality and the Path to Get There suggested that the future of pharmaceutical quality is Six Sigma, meaning that no more than 3.4 defects occur per million opportunities (at every manufacturing facility). The way to achieve this goal is to move from the current management standards to performance standards. The need for an additional incentive — the economic driver — was also recognized in the publication. The proposed path forward aims to achieve the long-standing vision of the FDA’s Center for Drug Evaluation and Research (CDER): “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive regulatory oversight.”
In today’s world of ever-increasing regulatory scrutiny on pharmaceutical quality we have all witnessed first-hand the public relations nightmare of adverse events, drug recalls, and even company closures. In response, pharma companies have set stricter rules and regulations for their employees to follow, to ensure they remain in compliance with regulators and avoid negative inspection results.
Sponsor companies and contract manufacturing organizations (CMOs) have a lot to consider to develop a clear guide for how their organizations will work together effectively. In this article, practical considerations are explored in addition to the FDA’s updated guidance.
On November 23, 2016, the Food and Drug Administration (FDA) published a revised draft guidance for Submission of Quality Metrics Data. The guidance includes significant changes to the earlier quality metrics draft guidance issued by the agency on July 28, 2015.