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Technician running a software validation process for a manufacturing client.

Keys to Success For GMP Software Validation

Before a GMP manufacturing facility implements a software system into their operations, that system must go through a comprehensive software validation process.  This multi-part process ensures that a manufacturing facility’s software is compliant with all FDA regulations, and all Good…

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DEA: Hemp CBD is a Schedule I Drug

Last week, the Drug Enforcement Agency (DEA) ruled that cannabidiol (CBD) falls within the Schedule I drug classification of the Controlled Substances Act (CSA) and has received an official drug code. Companies have 30-days to update their licenses and cease…

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FDA Releases Unique Device Identifier Draft Guidance

Zachary Brennan of the Regulatory Affairs Professional Society (RAPS) outlined the guidance from the Food and Drug Administration (FDA) about the expected content and forms for the Unique Device Identifier (UDI) for medical device manufacturers and distributors that are coming…

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Election 2016: The Future of Pharma Under Clinton

Note: This is not an endorsement of Hillary Clinton. InstantGMP™ will be reporting on various aspects of the Presidential candidates’ platforms and their potential impact. By Kelly L. Waters, Marketing Manager (Ms. Waters does not endorse Clinton, she’s just the…

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Election 2016: The Future of Pharma Under Trump

Note: This is not an endorsement of Donald Trump. InstantGMP™ will be reporting on various aspects of the Presidential candidates’ platforms and their potential impact. By Kelly L. Waters, Marketing Manager (Ms. Waters does not endorse Trump, she’s just the…

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