Quality/GMPs

Latest News


Digitalization of QbD Risk Assessments

The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

Digitalization of QbD Risk Assessments

Subjectivity in Quality Risk Management

The authors discuss subjectivity in the ICH Q9 (R1) guidance document.

Subjectivity in Quality Risk Management

Phase-appropriate Compliance for Cell and Gene Therapies

Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.

Phase-appropriate Compliance for Cell and Gene Therapies

EMA has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of a module on the quality requirements.