PDA TR 56-2026

Application of Phase-Appropriate Quality Systems and Good Manufacturing Practice to the Development of Biological Product Drug Substance

Technical Report 56 has been a global guide to best practices for the development of biological drug substance since 2012. This revision advises on what must be done to reduce the risk of delays, failures, and noncompliance to GMP during product development, method development and scale-up from phase 1 through phase 3 and validation, including best practices that should be implemented prior to GMP manufacturing. TR 56 gives information on preventing the application of commercial standards and regulations too early, diluting resources and making demands that may not be feasible in early phase. This revision also was designed to ensure that anyone with less experience and resources, starting the path of GMP product development, who as FDA described may "not know what they don't know" has clear recommendations of what "must" be in place to reduce the likelihood of delays and failures due to poor practices and noncompliance to GMP expectations.