Regulatory/GMP Compliance

Latest News

February 1st 2004

Qualification of Raw Materials for Biopharmaceutical Use

This article focuses on the front end of qualifying a new raw material from a given supplier. Once qualified, this status must be maintained by periodic review and requalification.

January 1st 2004

If Training Is So Easy, Why Isn't Everyone in Compliance?

October 1st 2003

Validation of Commercial-Off-the-Shelf Calibration Management Systems: Managing Instruments Cost-Effectively

By Jim Erickson

August 1st 2003

GLPs and the Importance of Standard Operating Procedures

By Kevin Robinson

July 1st 2003

Validation Outsourcing: Getting the Most Out of Your Client?Contractor Relationship

By Julie Paul, Katie Henchir

Pieces of the Inspection Puzzle: The Magnitude and Scope of Behind-the-Scenes Activities During an Inspection

ByBarbara Unger

July 1st 2003

A successful outcome to an FDA inspection is the fruit of planning, preparing, and training. Cultivate confident employees who are appropriately coached and clear about their responsibilities.