ISPE Releases First Guide from its Advancing Pharmaceutical Quality Program

December 15, 2020
Pharmaceutical Technology Editors

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations.

On Dec. 15, 2020, The International Society for Pharmaceutical Engineering (ISPE) announced the release of its most recent guide, ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System, as a part of its new program Advancing Pharmaceutical Quality (APQ), an initiative aimed at assessing and improving an organization’s quality management maturity.

According to an ISPE press release, the guide is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations. The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System touches on the APQ program, introduces the Assess, Aspire, Act, and Advance agenda, and covers the practical application of the APQ framework to the CAPA system element by assessing:

  • CAPA documentation
  • Problem identification
  • Root cause identification
  • Corrective and preventive actions
  • CAPA effectiveness
  • CAPA metrics
  • Governance, management oversight, and CAPA prioritization.

“The APQ Program recognizes that the ability to advance the maturity of quality management lies within the industry itself, and a key driver for this program is to provide a range of sustainable and practical quality management improvement strategies,” said Tami Frederick, global director, Quality Systems, Perrigo, guide co-lead, in the press release. “This quality management maturity program aims to identify good practices and good behaviors which support the continual improvement of quality management effectiveness within an organization.”

Source: ISPE