ANN ARBOR, Mich. — The U.S. Food and Drug Administration (FDA) recently recognized Peter Gough, Partner of NSF-DBA, with the FDA’s Leveraging/Collaboration Award for helping to develop risk-based approaches to pharmaceutical quality.  

NSF-DBA is part of NSF International’s Health Sciences Division and has provided pharmaceutical, dietary supplement and medical device training, consulting and auditing services worldwide for more than 25 years.  Peter has more than 35 years of experience in pharmaceutical manufacturing, control and quality management.  He earned a master’s degree in analytical chemistry from Kingston University (London) and an undergraduate degree in chemistry from the Royal Society of Chemistry.

FDA Leveraging/Collaboration Award

The FDA Leveraging/Collaboration Award recognizes an individual or company’s efforts to collaborate with other government or industry groups to advance the FDA's public health mission. Peter earned the award for participating in the Q9 Briefing Pack for the International Conference on Harmonisation (ICH Q9), which involved developing a structured approach to quality risk management for the pharmaceutical industry.  

Pharmaceutical Risk Management

As part of developing a structured approach to pharmaceutical risk management, ICH Q9 Risk Management outlines an agreed-upon process for pharmaceutical manufacturers and regulators and provides for common language. The three-stage risk management process addressed in ICH Q9 includes:

  1. Risk assessment, which includes risk identification, risk analysis and risk evaluation.
  2. Risk control, which includes the identification of possible risk reduction measures and, eventually, acceptance of the residual risk, which can never be zero.
  3. Risk review, which is the process of reviewing the risk assessment and risk control decisions based on experience to identify whether the risks have been adequately controlled and to take consequent actions.

Collectively ICH Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System provide a more structured way to define and control pharmaceutical products and their manufacturing process. All three are intended to work together to enhance pharmaceutical product quality.  This enhanced approach is usually referred to as the Quality by Design approach.

“Combined with ICH Q8 Pharmaceutical Development and Q10 Pharmaceutical Quality System, Q9 enables greater product and process understanding, which allows a more effective approach to the management of product quality and regulatory mechanisms. Our collaborative and structural approach to risk management, product quality and regulatory mechanisms will benefit the entire pharmaceutical industry, regulators and, most importantly, patients by improving both quality and efficiency,” said Peter Gough. “It is an honor to receive the FDA’s Leveraging/Collaboration Award.” 

For more information about NSF-DBA consultancy and in-house training services, visit nsf-dba.com or contact Jim Morris at +1 617-342-3625 (jim.morris@nsf-dba.com) or Neil Wilkinson (njw@nsf-dba.com) in the U.S. In Europe contact the U.K. office on +44 (0)1751 432999 or email mail@nsf-dba.com.

About NSF International: NSF International is an independent organization that certifies products and writes standards for food, water, dietary supplements and consumer goods to protect human health and the environment (nsf.org). Founded in 1944, NSF is committed to protecting public health and safety worldwide. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment. Additional NSF services include NSF Sustainability, management systems registrations delivered through NSF International Strategic Registrations (NSF-ISR) and NSF Education and Training programs.

NSF International's Health Sciences Division offers certification, training, consulting, GMP and GLP testing, R&D and auditing for the pharmaceutical, dietary supplement and medical device industries. The Health Sciences Division includes: NSF Pharmalytica, a GLP & GMP contract laboratory; NSF-DBA, which has more than 25 years of pharmaceutical, dietary supplement, and medical devices training expertise; NSF Reference Standards and NSF Dietary Supplements. NSF International developed the American National Standard for Dietary Supplements (NSF/ANSI 173) and tests and certifies supplements against this standard via the NSF Dietary Supplements Certification Program. NSF's Health Science Division operates globally throughout North America, Europe, Middle East, Africa, Asia and Latin America.

MEDIA CONTACT:
Greta Houlahan
NSF International
Phone: 734.913.5723
Email: houlahan@nsf.org