How risky is the FDA’s risk-based approach to compliance?

Q & A released — Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach

SALT LAKE CITY UT USA — MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM) — JULY 20 2005 — Three years after the US FDA introduced an initiative to modernize its approach to reviews and inspections of pharmaceutical companies, questions still abound.

The initiative called “Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century: A Risk-Based Approach,” represents a philosophical shift in the FDA’s policy approach. The goal is to bring pharmaceutical regulation to the 21st century level, by emphasizing science and placing more accountability on industry members.


What does “risk-based approach” really mean? How does it affect regulations? Does it entail more costs for industry? How do consumers and patients benefit from this?

MasterControl Inc, the leading provider of quality management software solutions for companies in FDA and ISO environments, recognizes how important compliance is to pharmaceutical companies. It has prepared the following Q&A to help you understand the FDA’s thinking regarding this initiative.


The MasterControl(TM) software solution consists of configurable, off-the-shelf products that automate, track, and manage documents and forms-based quality processes, to help pharmaceutical companies stay compliant.

MasterControl Inc, based in Salt Lake City, has been at the forefront of providing innovative electronic content management and quality systems since 1993. More than 400 companies worldwide use MasterControl to consistently meet FDA regulatory requirements and industry quality standards, such as ISO and QS/TS.


Jason Clegg
MasterControl Inc
6322 S 3000 E Ste 300
Salt Lake City UT USA 84121
800-825-9117 phone
801-942-4000 phone
[email protected]


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