Special Reports
September / October 2018

Special Report Quality Metrics

Special Report Quality Metric

ISPE Proposes an Advancing Pharmaceutical Quality Program

The ISPE Quality Metrics team has proposed an industry-led approach to advance pharmaceutical quality beyond the submission of data for three harmonized, reportable metrics: the Advancing Pharmaceutical Quality (APQ) prog ram. The basic framework of the program is to “assess and aspire” quality maturity.

ISPE Advances Its Focus on Cultural Excellence

Since the publication of ISPE’s groundbreaking Cultural Excellence Report in April 2017 the team behind its development remain committed to driving their message forward: Focus on culture and behaviors to deliver sustainable quality excellence. It has been a busy year. In addition to new publications and pioneering collaborations underway, ISPE Quality Culture Team members have been invited to participate in a range of international conferences to share the key concepts represented in the Six Dimensions of Cultural Excellence framework. The reception from industry and regulators alike has been a resounding endorsement of the work.

CAPA Maturity

Corrective and preventive actions (CAPAs) are indicators of company health. They demonstrate whether issues are acknowledged, tracked and, ultimately, remedied in an effective and permanent manner.

Metrics Reporting and Analysis

In mid-2017, ISPE established a cross-functional subteam (working title: “Metrics Reporting and Analysis”) under the Advancing Pharmaceutical Quality (APQ) core team to evaluate, summarize, and provide feedback on the FDA quality metrics portal. The results of that exercise are expected to be shared with ISPE members and companies. While this is still the primary charge of the subteam, delays in opening the portal gave the team an opportunity to take on a slightly broader and more thoughtful approach to the evaluation process.