Peter Gough, Hon DSc, MSc, CSci, CChem, FRSC, FCQI, CQP

A chemist with a master’s degree in analytical chemistry, Peter Gough has over 45 years’ experience of pharmaceutical manufacture, control and quality management, culminating in the role of Senior Quality Consultant in Eli Lilly’s Global Quality Systems division. He has broad experience, particularly with quality control laboratories and the manufacture of solid dosage forms and active pharmaceutical ingredients. He was previously a partner at David Begg Associates (DBA).

Mr. Gough has extensive experience defining quality systems at a global level. He is eligible to act as a Qualified Person and is an Honorary Lecturer in GMP and Pharmaceutical Quality Management at the University of Strathclyde. He is a former member of the European Federation of Pharmaceutical Industry Association’s (EFPIA) Manufacturing and GMP ad hoc group and was EFPIA topic leader on the ICH Expert Working Group which prepared the Q9 Quality Risk Management Guideline. He was given the Leveraging Collaboration Award by the U.S. FDA for his contribution to the online ICH Q9 briefing pack. He has been a passionate advocate of the Quality by Design (QbD) approach to the development, registration and manufacture of pharmaceuticals.

Mr. Gough has been a strong proponent of the use of statistical data analysis techniques to drive continual improvement within pharmaceutical quality management systems.

Areas of recognized expertise include:

• Pharmaceutical law
• The role and duties of the Qualified Person
• Pharmaceutical quality management systems
• Pharmaceutical quality risk management
• Good Control Laboratory Practice (GCLP)
• Managing out of specification (OOS) and out of trend (OOT) results
• The application of statistical process control tools
• The manufacture and control of oral solid dose products

Mr. Gough is a Fellow of the Royal Society of Chemistry and of the UK Chartered Quality Institute (CQI) and former chairman of the Royal Society of Chemistry’s Qualified Person Assessor Panel and of the CQI’s Pharmaceutical Quality Group.