Technical Report No. 56 (Revised 2026) outlines a GMP‑compliant, phase‑appropriate quality management system (QMS) spanning preclinical development through clinical phases and commercial readiness
BETHESDA, Md., March 11, 2026 /PRNewswire-PRWeb/ -- The Parenteral Drug Association (PDA) announces the publication of Technical Report No. 56 (Revised 2026), a comprehensive update to its long‑standing global guide on best practices for the development of biological drug substances. First published in 2012, TR-56 has become a foundational reference for manufacturers navigating the complexities of early‑ to late‑stage development. It has been revised in response to today's increasingly complex regulatory and development landscape, providing practical, phase‑appropriate guidance designed to reduce delays, failures, and noncompliance with Good Manufacturing Practice (GMP) expectations
"This revision of Technical Report No. 56 will be a great resource to support the industry's focus on GMP compliance and aid companies in balancing compliance expectations with manufacturing operations," PDA Sr. Director of Scientific and Regulatory Affairs Josh Eaton said. "PDA is grateful to the authoring team for their time and commitment to produce this Technical Report in order to promote best practices of biological drug substance from preclinical through clinical development to its commercial readiness. Special thanks go to the leadership of the Co-Leads Rebecca Brewer of Quality Executive Partners, Amnon Eylath of Broad Spectrum GXP™, LLC, and Nancy Kirschbaum of Nancy Kirschbaum Regulatory Consulting, LLC for guiding the team and effort to success."
The revised TR-56 outlines a GMP‑compliant, phase‑appropriate quality management system (QMS) spanning preclinical development through clinical phases and commercial readiness. It emphasizes what must be in place at each stage of development—without imposing commercial‑phase expectations prematurely—helping organizations avoid the costly misapplication of standards that can dilute resources and slow progress in early phases.
Examples throughout TR 56 illustrate generally accepted expectations of ICH Members for clinical drug substance manufacturing and process validation, offering practical insight into how quality systems and controls should scale as development advances. While focused on biological drug substance, the guidance also highlights upstream activities—such as research, development, and toxicity testing—that, while not strictly GMP, are critical to ensuring patient safety and building a robust foundation for later‑stage manufacturing and regulatory success.
Technical Report No. 56 (Revised 2026) is intended for a broad audience, including academic institutions, start‑ups, virtual companies, and established manufacturers. By promoting science‑ and risk‑based decision-making, the report equips organizations to plan, implement, and execute development programs that are both efficient and compliant—helping to bring biological therapies to patients without unnecessary delay
The revised report is now available through PDA's publication channels and is currently free to current members. It sells for $325.00 for nonmembers on PDA's Bookstore.
About The Parenteral Drug Association
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 The Parenteral Drug Association
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