Quality and Regulatory Sourcebook, March 2024 eBook

Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.

The evolution of therapeutic modalities drives the adoption of single-use technologies.

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

IREM can be used for effectively assessing and mitigating risks and improving the overall sterility assurance level in all types of aseptic processing lines.

Regulatory submissions are a critical step in bringing new drugs and medical interventions to market, the success of which heavily relies on the quality and fitness of the data presented to the regulatory bodies.