Just Released: PDA /ANSI Standard 06-2025, Quality Culture Assessment of Quality Culture Guidance Documents, Models, and Tools 26 February, 2025

This new standard provides guidance on evaluating and understanding quality culture in the pharmaceutical/medical device industry. It identifies five key focus topics critical for establishing and maintaining a mature quality culture: Leadership Commitment Communication and Collaboration Employee Ownership and Engagement Continuous Improvement, and Technical Excellence.

Bethesda, Md., February 26, 2025 /PRNewswire-PRWeb/ --

PDA today released PDA /ANSI Standard 06-2025, Quality Culture Assessment of Quality Culture Guidance Documents, Models, and Tools on its bookstore. This new standard provides guidance on evaluating and understanding quality culture in the pharmaceutical/medical device industry. It identifies five key focus topics critical for establishing and maintaining a mature quality culture:

Leadership Commitment
Communication and Collaboration
Employee Ownership and Engagement
Continuous Improvement, and
Technical Excellence.

The standard supports the assessment of existing quality cultures and alignment with health authority and regulatory expectations. It also emphasizes collecting verifiable data, identifying improvement opportunities, and measuring the integration of a quality mindset into daily work. Additionally, it provides a thorough review of the references and summarizes best practices by highlighting the key characteristics that each provides for an organization to review.

The goal of this standard is to provide detailed comparisons of how each model addresses the key factors in pharmaceutical quality culture so that an organization can choose what is most effective for their needs, it does not provide pro and con opinions.

Josh Eaton, PDA Sr. Director of Scientific and Regulatory Affairs says, “This new PDA/ANSI Standard will be a great resource to support the industry’s growing focus on ensuring that quality culture is properly assessed, developed, and implemented with the goal of improving operations and product safety and supply. PDA is grateful to the authoring team for their time and commitment to produce this PDA/ANSI Standard to promote best practices and awareness in quality culture. Special thanks go to the leadership of the Co-Chairs Susan Schniepp of Regulatory Compliance Associates, A Nelson Labs Company; Althea Micklewright of Pfizer Inc.; and Rebecca Walden of the Irish Blood Transfusion Service for guiding the team and effort to success.”

For more information about or to purchase the standard, go to: https://www.pda.org/bookstore/product-detail/8259-pda-ansi-standard-06-2025

About PDA Standards

PDA Standards are global consensus documents, prepared by volunteer teams of subject matter experts working in the pharmaceutical industry, regulatory authorities, and academia. The level of expertise of the authoring team and those participating in the global review prior to publication ensure a broad perspective reflecting the best thinking and practices currently available.

More information about PDA Standards: https://www.pda.org/scientific-and-regulatory-affairs/standards/pda-ansi