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GMP Compliance Series – Part 10: Maintaining Equipment

GMP Problems: Dietary Supplements have to be manufactured under the cGMP regulations specified in the Dietary Supplements Health and Education Act that became law in 2007. Many manufacturers or distributors of dietary supplements have been inspected by the FDA since…

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GMP Manufacturing of Dietary Supplements

GMP Manufacturing of Dietary Supplements Not everyone in the dietary supplement business is aware that the FDA now requires Good Manufacturing Practices (GMPs) in manufacturing, packaging, labeling, or holding operations for dietary supplements. Any company involved has to establish and to…

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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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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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