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Voices of the Board

One Quality Voice

PDA Task Force Unites Quality Leaders for Positive Change

by: Melissa Seymour, Biogen

In 2016, PDA established the Post-Approval Change: Innovation for Availability of Medicines (PAC iAMSM) task force. The focus of this task force has been to drive dialogue between industry and regulators to transform the current paradigm for post- approval changes (PACs). Early on, the task force identified an effective pharmaceutical quality system as a prerequisite for innovation through PACs as part of lifecycle management. This resulted in the document, “PDA Points to Consider: Technical Product Lifecycle Management, Pharmaceutical Quality System Effectiveness for Managing Post-Approval Changes.”

This task force is also planning to deliver a technical report titled Post-Approval Change Management and Implementation for Biologics and Pharmaceutical Drug Products – A User’s Guide. This technical report is intended to provide the reader with practical solutions aligned with ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management concepts, including specific examples and tools. A prime focus within this technical report involves relying on a company’s internal pharmaceutical quality system as a bedrock for managing change.

In late August, the task force assembled senior industry quality leaders at PDA’s headquarters in Bethesda, Md., to collaborate on how the industry can drive continuous improvement in the management of PACs by leveraging the pharmaceutical quality system. Twenty heads of quality, representing the branded, generic, biotech and contract manufacturing sides of industry were in attendance. A notable outcome of this workshop was a commitment from the quality leaders to create “One Quality Voice” on the importance of implementing new knowledge to continually improve in order to meet the objective of reliably producing high quality products for patients, per CDER’s Janet Woodcock. This was an energetic and passionate discussion that led to some practical actions for industry to take including:

  • Standardizing the approach for management of PACs
  • Developing standardized risk-based approaches to PACs to allow timely implementation of new knowledge via an effective pharmaceutical quality system
  • Raising awareness of the global complexities associated with PACs
  • Defining metrics capable of distinguishing an effective pharmaceutical quality system

The senior quality leaders will continue to meet and drive progress on tangible solutions for managing PACs in the pharmaceutical quality system. The PAC iAMSM task force welcomes participation from other heads of quality who did not attend this meeting.

The complexity of global regulatory PAC/variation processes is a challenge for the industry, and the PAC iAMSM task force is another example of PDA’s commitment to advancing continuous improvement and facilitating dialogue to benefit the patients we serve. More information regarding the task force can be found at the PAC iAMSM website.