Regulations Vary Worldwide but Risk Management is Common Demoninator

2015-bl-6-ways-ensure-qms-meets-fda-iso-page-imageTo compete in today's global market, regulated companies must comply with innumerable requirements, directives, and standards coming from regional, national, and international bodies. While these requirements vary based on industry and the regulatory body involved, they do have a common denominator—emphasis on risk management.

"The focus on risk management worldwide can be attributed in part to the changing nature of risk in global supply chains...."

The focus on risk management worldwide can be attributed in part to the changing nature of risk in global supply chains, said Walt Murray, MasterControl's director of quality and compliance services. He cited Kim Trautman, senior scientific advisor at FDA's Center for Devices and Radiological Health, who said at the annual medical device conference that with global supply chains, it is increasingly difficult to distinguish risk based on where the products are coming from and that so many different regulatory bodies are now involved.

Murray made a presentation titled "Implosion of Regulation: Convergence with Risk as the Common Denominator" at MasterControl's 2012 Masters Conference recently held in Nice, France. "Risk management is increasingly an integrated component of any quality management system and is necessary for it to be valid in any decision making related to a quality system," he said.

Changing Nature of Risk

Talking about the changing nature of risk, Murray cited the United States as an example, saying that 70 percent to 85 percent of imported seafood and produce denied entry by the U.S. have been rejected due to potentially dangerous violations such as presence of pathogens, chemical contamination, and other sanitary violations.

The U.S. FDA is implementing the Food Modernization Safety Act, which provides critical preventive controls and allows greater FDA oversight over the safety of about 85 percent of U.S. food products. Enforcing the new law is a massive undertaking. To leverage resources, the FDA uses international comparability assessments, taking advantage of food safety assessments made by its regulatory counterparts in other countries.

Murray explained the FDA's new strategy of partnering with global counterparts to create global coalitions of regulators focused on ensuring and improving global product safety. The FDA has joined the pharmaceutical inspection cooperation composed of manufacturing inspectorates from 39 countries. The agency also helps set global standards for drug regulation through the International Conference on Harmonization (ICH).

In his presentation, Murray discussed various regulations and requirements (FDA, WHO GMP, EU GMP) and guidelines from ICH and industry organizations (ISPE, PDA, IPEC, APIC, etc.) that apply to life science, manufacturing, food and beverage, and other regulated industries.

In addition, Murray talked about the following:

  • A new voluntary program, called EXCiPACT Scheme, for independent, third-party certification of manufacturers and suppliers of excipients;
  • Different aspects of quality management: supplier quality management (SQM), quality risk management (QRM), quality audit management (QAM), quality document management (QDM), quality event management (QEM), and CAPA;
  • New top-down approach to system inspection; and
  • Quality by Design as a convergence of science and compliance.

Murray has more than 25 years of experience as a quality and regulatory expert. He and the MasterControl Quality and Compliance Consulting Team provide workshops, education, and consulting services on the following core competency areas: quality event management (CAPA), QRM, SQM, QAM, and QDM.

For more information about MasterControl workshops, go to:

Cindy Fazzi, a copywriter at MasterControl, Inc., writes about the life sciences industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master's degree in journalism from Ohio State University.

Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.