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Serious Quality Problems

This is the second of a two part article summarizing the results of a survey of manufacturing and quality experts who were poled about the most serious manufacturing and quality problems they have incurred. What’s Wrong with Paper-Based Quality It…

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Serious Production Problems

We collected background information for an article comparing traditional paper-based pharmaceutical manufacturing with electronic manufacturing using an internet survey.  This is a summary of the answers about the most serious productions problems faced. Improving quality and manufacturing of pharmaceuticals Improvement…

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Paperless GMP Manufacturing

A paperless GMP manufacturing operation  sounds counter-intuitive. Almost all operations use paper forms especially pharmaceutical GMP manufacturing.   When you think about the simplest processes such as ordering and receiving materials there has to be paper in use.  Or maybe not.…

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Designing a Virtual Quality System

When PharmaDirections undertook a project to design and build a GMP manufacturing facility that would become a site for InstantGMP™ production, one of the key considerations was designing a virtual quality system.  The requirements were to have policies, procedures, documentation…

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The Founding of InstantGMP

The concept behind InstantGMP started in 2004 when PharmaDirections was engaged to build a manufacturing facility that could be mostly operated with remote staff. The infrastructure for virtual drug development was getting better due to the maturity of the internet…

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