PharmTech May June 2026

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.

This article evaluates a structured, risk-based framework for the development, execution, and life cycle governance of master production and control records and batch production and control records systems aligned with current good manufacturing practice requirements and internationally harmonized pharmaceutical quality system guidance.

High-concentration formulations and patient centricity are challenges to the formulation of biosimilars, which already face patent protection barriers.

This article provides a statistically defensible and GMP-aligned justification for continued IPC reliance on computed net fill weight when equivalence in mean and variance can be demonstrated.

Hybrid cloud architecture enables pharma organizations to balance public cloud scalability with private infrastructure control, accelerating drug development while maintaining regulatory compliance.