News|Videos|June 25, 2026

Pharma Fundamentals: Biologics Development and PDA’s Technical Report No. 56

Name: Pharma Fundamentals: Biologics Development and PDA’s Technical Report No. 56
Uploaded: 2026-06-25T17:00:00Z
Duration: 22M58S
Description: Pharma Fundamentals: Biologics Development and PDA’s Technical Report No. 56

Author(s)Susan J. Schniepp, Amnon Eylath, Susan Haigney

This episode of Pharma Fundamentals explains the difference between a quality system for biologics compared with small-molecule drugs and the Parenteral Drug Association’s revision to Technical Report No. 56.

In this episode of PharmTech’s Pharma Fundamentals, Susan Schniepp, distinguished fellow with Nelson Labs and a member of PharmTech's editorial advisory board, and Amnon Eylath, president and founder of Broad Spectrum GXP, discuss biologics development, the quality system, and the Parenteral Drug Association's (PDA) revision to Technical Report No. 56 (TR56),¹ which Eylath is a co-author on.