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Quality by Design

Kymanox 02Jun2017 Quality+Compliance

Quality by Design (QbD) is a structured approach to process development that emphasizes science and risk management principles. Applying QbD allows companies to develop manufacturing …

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designqbdqualityquality by design

Materials Management

Kymanox 31May2017 Quality+Compliance

Of all the subsystems of a Pharmaceutical Quality System, the Materials Management subsystem may require the most cross-functional collaboration and teamwork. For example, the Materials …

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materialsquality

Item Specifications

Kymanox 31May2017 Quality+Compliance

A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria …

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designitemqualityspecifications

FAT / SAT Support

Kymanox 20Mar2017 Project Management, Quality+Compliance, Technical Operations, Validation

Investing in equipment should never have to be a risk. Testing equipment and reviewing documentation for traceability purposes does a great deal towards lowering the …

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factoryfatqualityrisksattesttesting

Process Validation

Kymanox 03Mar2017 Validation

Current Good Manufacturing Practices (CGMPs) enforced by the FDA require that all manufacturing processes be validated. Validation ensures that controlling the inputs (i.e. parameters) within …

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gmplife cyclelifecycleprocessqualitysafety

Quality Management System Development

Kymanox 23Feb2017 Quality+Compliance

A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate …

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developedevelopementmanagementqualitysystem

Quality Risk Management

Kymanox 23Feb2017 Quality+Compliance

Quality Risk management (QRM) is a systematic process for the assessment, control, communication, and review of risks to quality of the drug product across the …

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emafmeaftaichphaqrmqualityrisk

Aseptic Manufacturing

Kymanox 14Dec2016 Technical Operations

Safety First.  That’s the mantra echoed across almost every industry in the world.  This is especially true in the life sciences industry.  But this safety …

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Asepticmanufacturingqualitysterilesterilization

Detailed Product and Process Description (DPPD)

Kymanox 14Dec2016 Quality+Compliance

In Big Pharma and the life sciences industry, product development is a massive effort that spans several different functions and documents. This process is not …

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cppdppdqmsquality
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      • ← Back
      • Analytical Science
      • Packaging Technology and Engineering
      • Product Development
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    • Validation
      • ← Back
      • Cleaning Validation
      • Clean Utilities Engineering
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      • Analytical Method Validation
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