APQ Guide: Corrective Action & Preventive Action (CAPA) System


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Published: November 2020
Pages: 136

What is the current state of your organization’s Corrective Action and Preventive Action (CAPA) System? Is it robust, consistent, and efficient? The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System provides a quality management framework for assessing and advancing CAPA system maturity level by evaluating:

  • CAPA Documentation
  • Problem Identification
  • Root Cause Identification
  • Corrective and/or Preventive Actions
  • CAPA Effectiveness
  • CAPA Metrics
  • Governance, Management Oversight, and CAPA Prioritization.

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in the planned four-part series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance. The Guide Series is part of ISPE’s newest initiative, Advancing Pharmaceutical Quality (APQ), a comprehensive program for assessing and improving an organization’s quality management maturity.

Built upon the ICH Q10 Pharmaceutical Quality System (PQS) model, the APQ program is an industry-led approach that seeks to advance pharmaceutical quality beyond the submission of data for harmonized, reportable metrics. The program is aligned with international initiatives that promote quality excellence, as well as with the FDA’s interest in quality management maturity and rating the maturity of manufacturing facilities, as cited in their 2019 Drug Shortages report. The result is a program that organizations can leverage to ensure a continuous supply of quality medicines to patients.

The APQ Guide Series provides a practical set of tools and systematic approaches for organizations to proactively advance the maturity and effectiveness of the following PQS elements:

Each area will be covered in depth using the APQ framework of Assess, Aspire, Act, and Advance, providing tools and Key Performance Indicators (KPIs) for organizations to incorporate into their quality program. Each Guide will contain quantitative and qualitative tools to assess the organization’s current state of quality, diagnose gaps, and identify improvement targets – Assess and Aspire. The Guides will discuss using this information to develop an Improvement Action Plan that the organization can execute and evaluate for effectiveness – Act and Advance. The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System focuses on application of the APQ framework to the CAPA system.

Guide Core Team

Lori Rae Chelemedos
Founder/Principal Consultant
Pac-Side LLC
Kira L. Ford
Vice President - QA Compliance
Eli Lilly
Tami J. Frederick
Senior Director, Corporate Quality Systems & Cultural Excellence
Andrew Denny
Executive Director, Predictive Quality
Bristol-Myers Squibb
Ketan Gujarathi
Director, Strategy & Business Operations | Global Mfg Operations
Bristol-Myers Squibb
Blaine Spangler, BS
Sr. Manager - Quality
Baxter Healthcare Corp