cGMPs

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.

Articles

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Shutterstock 638418178
Shutterstock 638418178
Shutterstock 638418178
Shutterstock 638418178

Key considerations for CGMP raw materials compliance

It is never too early to consider CGMP requirements in pharma
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Pm22 Hero 854x480 Quality
Pm22 Hero 854x480 Quality
Pm22 Hero 854x480 Quality
Pm22 Hero 854x480 Quality

Beyond ‘good’ practices

Pharma quality regulation has evolved beyond routine CGMP compliance toward a more holistic, proactive approach
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PM2208-HERO-575x327-Supply
PM2208-HERO-575x327-Supply
PM2208-HERO-575x327-Supply
PM2208-HERO-575x327-Supply

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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PM2208-HERO-575x327-Development
PM2208-HERO-575x327-Development
PM2208-HERO-575x327-Development
PM2208-HERO-575x327-Development

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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PM2204-HERO-880x500-Quality-copy
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PM2204-HERO-880x500-Quality-copy

Getting drug quality right the first time

CAPA remains an integral element of cost-effective quality management in pharma
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PM2202-HERO-575x327-Operations-copy
PM2202-HERO-575x327-Operations-copy
PM2202-HERO-575x327-Operations-copy
PM2202-HERO-575x327-Operations-copy

Pharma’s hybrid inspection model

Four strategic steps to creating and executing a hybrid audit protocol
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PM2202-HERO-575x327-CoverStory1
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PM2202-HERO-575x327-CoverStory1
PM2202-HERO-575x327-CoverStory1

Emergent BioSolutions: The path to re-emergence

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

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

How a commonly overlooked component of pharma facilities is impacting your bottom line
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shutterstock-1391912567
shutterstock-1391912567
shutterstock-1391912567
shutterstock-1391912567

Stealing pharma's sunshine

How sunscreen is driving a resource and capacity shortage
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PM2005-Quality-Hero
PM2005-Quality-Hero
PM2005-Quality-Hero
PM2005-Quality-Hero

Making the shift

Moving from a compliance-based paradigm to a true quality-based culture
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PM1912-Syringe-Butterfly
PM1912-Syringe-Butterfly
PM1912-Syringe-Butterfly
PM1912-Syringe-Butterfly

Carcinogenic butterflies

Recent recalls may alter the path of quality in pharma
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Figure-2-Pfizer
Figure-2-Pfizer
Figure-2-Pfizer
Figure-2-Pfizer

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

Exploring best-practice manufacturing strategies for highly potent oral solid dosage forms
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Screen-Shot-2018-12-21-at-2.53.14-PM
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Regulatory Rewind

A mix of the biggest hits from 2018
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Atrium Innovations Modernizes Quality Management

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