Autoren

Chemist

1977-1980 Study of Chemistry / University of Bristol, United Kingdom

1980-1983 Completion of Doctorate (University of Bristol, United Kingdom)

1983 - 1987 BP Chemicals, Hull, UK, Chemist

Explore the use of Organometallic species as catalysts in the synthesis of oxygenated carbon compounds using C₁ feedstocks; optimisation of manufacturing plant; development of new processes.

1987 – 1992 Croda, Cowick Hall, UK, Chemical design and marketing

Design of performance chemicals at laboratory scale and demonstration of their effectiveness by performance testing; presentation of results to customers and use of feedback to re-design chemicals. Implementation of successful designs at plant scale.

1992 – 1993 Croda, Rawcliffe Bridge, UK, Chemical Development

Supervision of a team of R&D chemists covering new product and process development activities. Maintenance of quality critical computer master data.

1993 – 1999 Croda, Rawcliffe Bridge and Leek, UK, Quality Assurance

Maintenance of quality critical computer master data. Implementation of ISO 9002:1994, coordinating and driving continuous improvement activities (particularly involving IT applications and redesigning documentation systems), hosting customer audits. Enhancing the Quality management system to include links to SIO 14001 and GMP elements.

1999 – 2001 Croda, Rawcliffe Bridge, UK, IT Implementation.

Implementation of SAP R/3 Quality Management module for use by Croda globally. Transport of master data from legacy system to SAP. Although not a GMP project, the lifecycle was the same as the validation timeline.

2001 – 2004 Croda, Rawcliffe Bridge UK, Quality Assurance

Further design and implementation of quality management system. Registration of site to PQG PS 2100:2002 GMP for pharmaceutical excipients. Project leader for API plant installation, qualification and validation. Successful MHRA inspection (1^st in company).

2004 – 2007 Croda, Leek UK, Quality Assurance

Enhancement of quality management system to meet ICH Q7 across the whole site (from ISO 9001). Project Management for design and implementation of an API onto site. Successful MHRA inspection.

2007 – 2010 Croda, Cowick Hall UK, Quality Assurance

Install and develop a department for product stewardship issues. Lead the UK, European sites in the development of QA and GMP in all aspects of operations and supply of our products.

Special Activities

Co Author of

1. PS:9100:2002 Pharmaceutical Excipients. The application of ISO 9001: 200 and GMP guide for pharmaceutical excipients. Pharmaceutical Quality Group 2002. ISBN 0906810 83 3
2. The European Federation for Cosmetic Ingredients GMP Guide for Cosmetic Ingredients 2005 and the European Federation for Cosmetic Ingredients GMP Certification Scheme for Cosmetic Ingredients 2008.
3. The Joint IPEC-PQG Good Manufacturing Practices Guide for pharmaceutical excipients 2006. International Pharmaceutical Excipients Council / Pharmaceutical Quality Group
4. The Joint IPEC-PQG Good Manufacturing Audit Practices Guide 2008. Pharmaceutical Excipients Council.
5. The IPEC Qualification of Excipients for use in Pharmaceuticals 2008. Pharmaceutical Excipients Council
6. Chapter 5: Manufacturing Cosmetic Ingredients according to Good Manufacturing Principles
7. Volume 2 Global Regulatory Issues for the Cosmetic Industry, Ed Karl Lintner, William Andrew 2009. ISBN 978 8155 1569 2
8. The IPEC Quality Agreement Guide and Template 2009. Pharmaceutical Excipients Council
9. The IPEC Quality Agreement Guide and Template 2009. Pharmaceutical Excipients Council
10. The IPEC Excipient In formation Package (EIP) Template and User Guide 2009. Pharmaceutical Excipients Council
11. The IPEC Excipient Stability Program Guide and Template 2009. Pharmaceutical Excipients Council

2008-2009 Chair IPEC Europe GMP Committee

2009-date Chair IPEC Europe Excipient Certification Committee

Publications at Maas & Peither GMP Publishing:

• GMP-MANUAL
  (Author of the chapter Excipients)