Pharmaceutical Technology Quality and Regulatory Sourcebook March 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.

The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.

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

Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.

By leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.

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