These documents reflect PDA's ongoing dedication to providing the pharmaceutical industry with high-quality, practical resources that promote excellence in sterile product manufacturing.
BETHESDA, Md., Nov. 11, 2025 /PRNewswire-PRWeb/ -- The Parenteral Drug Association (PDA) is proud to announce the release of three new documents that reinforce its commitment to supporting innovation, quality, and best practices in pharmaceutical manufacturing. Among these is a groundbreaking new document type—the Manufacturing Technology Guide, designed to provide practical guidance on process and equipment selection.
Technical Report No. 22 (Revised 2025): Process Simulation for Aseptically Filled Products
This updated report offers comprehensive guidance on the design and execution of aseptic process simulations, a cornerstone of sterile product manufacturing.
"Technical Report No. 22 (Revised 2025) will be a great resource to support the industry's continued focus on proper design and execution of aseptic process simulations," said Josh Eaton, PDA Sr. Dir., Scientific and Regulatory Affairs. "Special thanks go to the leadership of the co-chairs Marcia Baroni of Emergent Biosolutions and Gabriele Gori of Chiesi Farmaceutici S.p.A for guiding the team and effort to success."
https://www.pda.org/bookstore/product-detail/8471-technical-report-no-22-revised-2025
Manufacturing Technology Guide No. 1: Aseptic Filling, Engineering, and Operation
Marking the launch of a new class of PDA publications, this guide provides actionable insights into aseptic filling technologies tailored to specific product attributes.
"PDA is excited to announce the release of its first ever Manufacturing Technology Guide!" said Josh Eaton, PDA Sr. Dir., Scientific and Regulatory Affairs. "This new document class will aid in process and equipment selection and implementation decisions. The vision and execution of this document is the result of the dedication of the authoring task force and its leadership: co-chairs Rebecca Brewer of Quality Executive Partners (retired) and Mauro Giusti of Eli Lilly Italia."
https://www.pda.org/bookstore/product-detail/8472-manufacturing-technology-guide-no-1
Technical Report No. 26 (Revised 2025): Sterilizing Filtration of Liquids
This revision addresses the critical role of sterilizing filtration in removing microorganisms without compromising product quality.
"This revision of TR 26 will be a great resource to support the industry's growing focus on removal of microorganisms from a fluid stream without adversely affecting pharmaceutical product quality," said Josh Eaton, PDA Sr. Dir., Scientific and Regulatory Affairs. "This much needed update to address updated requirements from EU Annex 1 and advances in technology was facilitated by the leadership of the co-chairs Maik Jornitz of BioProcess Resources, LLC and William Peterson of Merck & Co., Inc.".
https://www.pda.org/bookstore/product-detail/8489-tr-no-26-revised-2025-sterilizing-filtration
These documents reflect PDA's ongoing dedication to providing the pharmaceutical industry with high-quality, practical resources that promote excellence in sterile product manufacturing.
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 pharma manufacturing science and regulation, so members can better serve patients.
Media Contact
Walter Morris, www.pda.org, 1 3016565900, [email protected], www.pda.org
SOURCE www.pda.org
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