InstantGMP Blog | Good Manufacturing Practices

Predictive Quality in Pharma: Why Clean Data Comes First

Predictive Quality in Pharma: Why Clean Data Comes First...

Written by Dr. Richard Soltero, President, InstantGMP Every vendor selling AI for pharmaceutical qua...

InstantGMP Software That Made an FDA Inspection a Non-Event

InstantGMP Software That Made an FDA Inspection a Non-Event...

Most dietary supplement makers treat an FDA inspection as a week to be survived. They are not wrong ...

AI Quality Management Starts Where Data is Entered

AI Quality Management Starts Where Data is Entered...

Written by Dr. Richard Soltero, President, InstantGMP, Inc. In my experience, I have seen a lot of e...

The Operator Rounding Error that Fails FDA Inspections

The Operator Rounding Error that Fails FDA Inspections...

In 2023, roughly 40% of FDA citations involved a data integrity issue. What is surprising to people ...

The Quality Problem AI Couldn’t Have Predicted

The Quality Problem AI Couldn’t Have Predicted...

Written by Dr. Richard Soltero, President, InstantGMP, Inc. Quality has a way of finding the hole in...

Ensuring GMP Compliance through Effective Equipment Management

Ensuring GMP Compliance through Effective Equipment Manageme...

Proper management of production equipment is a cornerstone of Good Manufacturing Practice compliance...

How AI Is Reshaping Quality Management Across Global Manufacturing

How AI Is Reshaping Quality Management Across Global Manufac...

Written by Dr. Richard Soltero, President, InstantGMP, Inc. Most quality problems that occurred in m...

QMSR and Your Digital Systems: What FDA Inspectors Expect Now

QMSR and Your Digital Systems: What FDA Inspectors Expect No...

Written by Dr. Richard Soltero, President, InstantGMP, Inc. Your System Is Now the Evidence Most qua...

GMP Software Built on ISO 9001: Why It Matters for Your Compliance

GMP Software Built on ISO 9001: Why It Matters for Your Comp...

Written by Dr. Richard Soltero, President, InstantGMP, Inc. The Question Nobody Asks When Evaluating...

GMP Compliance and the Importance of Supplier and Vendor Qualification

GMP Compliance and the Importance of Supplier and Vendor Qua...

Qualifying suppliers and vendors is a critical aspect of ensuring GMP compliance. A robust vendor ...