BioPharm International Quality and Regulatory Sourcebook 2023

Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.

Organizations can better understand the maturity of AI-driven automation technology across their organization’s IT landscape through effective pharmacovigilance.

This article provides an overview of validation concept principles evolution to a life cycle risk-based approach with focus on compendial perspectives.

Quality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.