The quality services provided within development, production, quality control, supply chain and wholesale distribution are based on my experience from working more than 25 years in the pharmaceutical industry, both as QA and QC manager as well as Qualified Person, for both medicinal products and investigational medicinal products. Since 2014 I have worked as a consultant in my own company.
I find a great challenge in interpreting current regulations and guidelines in such a way that the quality management system becomes efficient, compliant and comprehensible.
As an independent consultant I have among others performed GMP and GDP audits in Europe, USA, China, Japan and Taiwan.
Below you find some examples of quality services offered:
- As certified Lead Auditor perform GMP and GDP audits worldwide of the whole manufacturing and distribution chain
- Perform a risk-based assessment of suppliers, manufacturers, laboratories and wholesalers
- Develop and maintain quality management systems
- Monitor new developments and trends in the GMP and GDP areas
- Prepare documentation required for a Certificate of Suitability (CEP) registration