GMP Posts

I18N L10N: Keys to a Global Quality Management System

I18N L10N: Keys to a Global Quality Management System

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

What is I18N L10N? Secret code? Part of an algebraic equation? A chemical compound? No, it’s not that mysterious or complex. It simply refers to the key elements needed to support enterprises in today’s global marketplace.

I18N is industry talk for “Internationalization.” The acronym represents the first and last letters of the word – I and N – and the 18 letters in between. (more…)

The Anatomy of Great Risk-Based GMP Audits

The Anatomy of Great Risk-Based GMP Audits

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

If you’re responsible for planning and carrying out your company’s internal audits, you know how much planning and effort it takes to monitor your quality system for GMP and ISO compliance. As your quality system has matured, you’ve probably noticed that certain sites, departments, or processes require more of your attention, while others are consistently in compliance and don’t need as much assistance. If this is the case in your organization, it’s time for you to consider a risk-based approach to your internal quality system audits. (more…)

FDA Wants Unique Device Identification System for Medical Devices

Mark Crawford

On July 3 the U.S. Food and Drug Administration proposed that most medical devices distributed in the U.S. must carry a unique device identifier (UDI). The hope is that this system will improve speed of response to adverse events reports, identify and issue target recalls more efficiently, and improve patient safety. (more…)

Wake Up and Watch Out: Getting Serious About QMS

“If it’s not broken, don’t fix it.” Really? If you only want to maintain the status quo, you might get away with letting sleeping dogs lie. But no one really wants to get hauled off by the dog catcher during a pleasant nap. Unfortunately, it’s happening every day to manufacturers who don’t take quality management seriously.

Quality management is about continuous improvement and product safety. And each time we optimize, we strengthen our preventive measures for avoiding unwanted surprises and disruptions in our operations. (more…)