Current Good Manufacturing Practice regulations (cGMPs) provide for systems that ensure proper design, monitoring, and control of manufacturing processes/facilities. Because deviations from cGMPs often result in 483s and warning letters from the FDA, it’s vital that pharma companies stay up to date on the latest changes in this area of their business.


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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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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

Pharma’s hybrid inspection model

Four strategic steps to creating and executing a hybrid audit protocol

Emergent BioSolutions: The path to re-emergence

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

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

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

Stealing pharma's sunshine

How sunscreen is driving a resource and capacity shortage

Making the shift

Moving from a compliance-based paradigm to a true quality-based culture

Carcinogenic butterflies

Recent recalls may alter the path of quality in pharma

Today's solid dose drugs: High potency, high stakes

Exploring best-practice manufacturing strategies for highly potent oral solid dosage forms

Regulatory Rewind

A mix of the biggest hits from 2018

Atrium Innovations Modernizes Quality Management

Atrium improves audits and complaints, change control, and product release processes with immediate access to information and operational visibility