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Key considerations for CGMP raw materials compliance

It is never too early to consider CGMP requirements in pharma
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Beating FDA to the punch

A proactive approach to risk mitigation can help weed out quality issues before they become citations
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Beyond ‘good’ practices

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

Developing a cell and gene therapy packaging strategy

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

Toward a collaborative pharma ecosystem

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

Getting drug quality right the first time

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

Supporting continued process verification

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

Juggling the regulatory complexities of global clinical trials

Deploying an automated process can help simplify safety and compliance information

Pharma’s hybrid inspection model

Four strategic steps to creating and executing a hybrid audit protocol

FDA year in review: 50 novel drug approvals and more

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

Emergent BioSolutions: The path to re-emergence

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

Pharma’s remote audits are here to stay

Distinctive strategies for doing remote audits successfully

Engineering Angles: Is your cold storage energy use through the roof?

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

The fallout from Aduhelm

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

Adapting to Brexit in the pharma industry

Exploring the impact of Brexit on UK pharma supply chain