Compliance

A proactive approach to risk mitigation can help weed out quality issues before they become citations

Pharma quality regulation has evolved beyond routine CGMP compliance toward a more holistic, proactive approach

Optimal packaging and labeling solutions help ensure the delivery of safe, effective viral vector products

A new biomanufacturing era demands that suppliers and manufacturers partner to efficiently bring new therapies to market

CAPA remains an integral element of cost-effective quality management in pharma

CPV is required for regulatory compliance but can also provide process improvements

Deploying an automated process can help simplify safety and compliance information

Four strategic steps to creating and executing a hybrid audit protocol

First-in-class and orphan drugs dominated the agency's 2021 approvals

How the Bayview plant put itself — and pandemic preparedness — on a better course

Distinctive strategies for doing remote audits successfully

How a commonly overlooked component of pharma facilities is impacting your bottom line

What our coverage of Biogen’s Alzheimer’s approval got right — and wrong — about the FDA’s decision

Exploring the impact of Brexit on UK pharma supply chain