QRM Process

Quality risk management (QRM) is a systematic process that assesses risk to the quality of a drug product. Here you will find broad pieces about strategic operational philosophies or risk management plans geared towards controlling risk or regulating quality in manufacturing.

Articles

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Optimizing supplier quality management

Adopting a risk-based model for inspections will flag suppliers who aren’t up to par
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Egnineering-Nov
Egnineering-Nov
Egnineering-Nov
Egnineering-Nov

Engineering Angles: Optimizing the facility design phase

Early planning will ensure pharma facilities meet requirements
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PM2110-HERO-575x327-Quality
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PM2110-HERO-575x327-Quality
PM2110-HERO-575x327-Quality

Maintaining compliance beyond the pandemic

Investing in employee readiness will be crucial to present and future success
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Redefining quality with analytical monitoring

How advances in biopharmaceutical characterization technologies are improving drug quality
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Compressed air quality

Particle analysis methods and ISO 8573 Standard updates
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PM1909-Quality-Main
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PM1909-Quality-Main

Pharma’s door to QRM success

The maturation of the cloud makes adoption of proactive quality risk management possible.

Modernizing manufacturing through a connected shop floor

Eliminating siloed systems in favor of streamlined applications allows for greater agility and stronger collaboration, enabling pharma to meet the new quality management demands...
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Cleanroom-Classifcations-sb
Cleanroom-Classifcations-sb

Compressed air — the overlooked element of cleanroom specifications

How applying cleanroom standards to compressed air systems can provide clarity and reliability
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mckinsey-digital-lab

The Future of Quality Control

Digital and automation technologies have created opportunities for change in pharma QC laboratories
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Pharma’s Reputational Tornado Zone

Companies that want to differentiate themselves need to adopt new operational and risk management defenses

3 Signs Employee Turnover is Impacting Your Operational Efficiency

Signs that CRO turnover is impacting your productivity, speed to market and bottom line.
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PM1711-Data-Chart
PM1711-Data-Chart
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PM1711-Data-Chart

Transforming Bioburden Risk with Digital Asset Intelligence

Asset intelligence gives cGMP manufacturers a new way to harness the information they need to prove manufacturing compliance
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PM1709-McKinsey-Chart1
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PM1709-McKinsey-Chart1

Toward Zero Defects: Using Analytics to Reshape Quality

Advanced analytical techniques can help companies identify and eliminate hidden sources of quality problems
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PM1706-EndressFig1-Small
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Simplifying Flow and Level Instrument Verification

Automatic verification can minimize the need for expensive instrument calibrations

Crazy About Quality and Compliance?

All elements and levels of the organization must be engaged to create effective manufacturing processes