“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 Technical Reports
PDA Technical Reports are global consensus documents, prepared by member-driven 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.
About PDA
The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information. PDA creates awareness and understanding of important issues facing the pharma community and delivers high-quality, relevant education to the industry. Since its founding in 1946 as a nonprofit organization, PDA has been committed to developing scientifically sound, practical technical information and expertise to advance pharmaceutical manufacturing science and regulation, so members can better serve patients. More information about PDA: https://www.pda.org/about-pda
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