Just Released: PDA/ANSI Standard 03-2025, Standard Practice for Quality Risk Management of Aseptic Processes 17 February, 2025

The PDA/ANSI Standard 03-2025, Standard Practice for Quality Risk Management of Aseptic Processes outlines a Quality Risk Management (QRM) method for assessing and controlling contamination risks in aseptic processing. This standard provides a lifecycle approach using a holistic evaluation of contamination control systems designed to minimize and/or prevent contamination during aseptic processing and ultimately ensure the safety of the products when delivered to the patient.

The standard ensures that all the measures and controls that are in place to manage microbiological risks are effectively evaluated to protect product quality and patient safety. The report addresses the needs of both industry and regulatory bodies by providing a risk-based approach to contamination control.

“This new PDA/ANSI Standard will be a great tool for the industry to ensure QRM principles and practices are applied and implemented correctly which will aid in the development of more comprehensive and effective contamination control strategies,” said Josh Eaton, PDA Sr. Director of Scientific and Regulatory Affairs.

Aseptic processing incorporates simultaneous processes, conditions, and factors offering opportunity for contamination. Therefore, an effective risk assessment method can mitigate risks associated with all sources of contamination. This standard provides an effective evaluation of aseptic processing to prevent all sources of contamination.

In detailing the QRM risk assessment method this standard contains information on the relevant fundamental principles, and concepts, a description of the risk assessment method, steps to perform the risk assessment, an example to assist the reader with performing the method, key terms and definitions, accompanied by suggested reading.

Eaton added, “Many thanks go to the authoring team for their time and commitment to produce this PDA/ANSI Standard in order to promote fundamental best practices in aseptic processes.”

The standard is available at the PDA Bookstore: https://www.pda.org/bookstore/product-detail/8231-ansi-pda-standard-03-2025

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