An NSF International Company Mr Peter Gough
Executive Director
MSc, CSci, CChem, FRSC, FCQI, CQP
- [email protected]
- +44(0)1751 432999
A chemist with a Masters degree in analytical chemistry, Peter has over 35 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.
Peter has extensive experience of defining quality systems at a global level. 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 guideline on Quality Risk Management. He was given the “Leveraging Collaboration Award” by the US FDA for his contribution to the on-line 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.
Peter has been a strong proponent of the use of statistical data analysis techniques to drive continual improvement within pharmaceutical quality management systems.
Areas of recognised expertise include:
- Pharmaceutical Law
- The role and duties of the Qualified Person
- Pharmaceutical Quality Management Systems
- Pharmaceutical Quality Risk Management
- Good Control Laboratory Practice
- 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
Peter is eligible to act as a Qualified Person and is a past chairman of the Royal Society of Chemistry’s Qualified Person Assessor panel.
He is a Fellow of the Royal Society of Chemistry and of the UK Chartered Quality Institute (CQI) and is a former chairman of the CQI’s Pharmaceutical Quality Group.
