ISPE has been in the forefront of the quality metrics dialog by hosting FDA and industry forums and workshops, conducting the industry’s first Quality Metrics Pilot Program, and providing input to the FDA draft Guidances based on experiential and objective pilot program data.
ISPE is fully aligned with FDA’s vision:
“A maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.”
The ISPE’s Advancing Pharmaceutical Quality (APQ) program proposes an industry-led approach to advance pharmaceutical quality beyond the submission of data for harmonized, reportable metrics. The basic framework of the program is to “assess and aspire” quality maturity.
ISPE has started to draft an industry-led Quality Maturity Framework, based on ICH Q10, which could be leveraged by industry and potentially FDA to achieve quality metrics program objectives.
Program goals for the Quality Maturity Framework include:
Guiding principles are:
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The influence of an organization’s quality culture has emerged as a key enabler from the recent public discourse on measuring performance and quality metrics for delivering outcomes that matter to the patient.
Cultural excellence requires that all employees are passionate about eliminating mistakes by making quality their driving principle. It goes beyond following the content of the quality policies and procedures by creating an environment that is focused on continuous improvement and learning.
Examining the powerful force that culture exerts on day-to-day operations within organizations, ISPE’s Quality Culture Team has established that although for many the concept of quality culture remains abstract, the behavioral impacts are very real indeed.
ISPE’s Cultural Excellence Team has developed a collection of practical, powerful tools and a comprehensive behavior-based approach for improving quality culture as a means of delivering enhanced quality outcomes.