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Compliance fire drill: Mock FDA audits for cleaning validation

Pharma manufacturers should incorporate worst-case scenarios into assessment processes

Anticipating AI regulations in pharma manufacturing

In a rapidly evolving regulatory landscape, leaders should remain ready to adapt to new legislation
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2024 pharma predictions: Regulations, sustainability and culture

In part 2 of our series, leaders weigh in on what the pharma industry can expect in the coming year
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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
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Developing a cell and gene therapy packaging strategy

Optimal packaging and labeling solutions help ensure the delivery of safe, effective viral vector products
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Toward a collaborative pharma ecosystem

A new biomanufacturing era demands that suppliers and manufacturers partner to efficiently bring new therapies to market
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Getting drug quality right the first time

CAPA remains an integral element of cost-effective quality management in pharma
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Supporting continued process verification

CPV is required for regulatory compliance but can also provide process improvements
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Juggling the regulatory complexities of global clinical trials

Deploying an automated process can help simplify safety and compliance information
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Pharma’s hybrid inspection model

Four strategic steps to creating and executing a hybrid audit protocol
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FDA year in review: 50 novel drug approvals and more

First-in-class and orphan drugs dominated the agency's 2021 approvals
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Emergent BioSolutions: The path to re-emergence

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