• A "virtual" company received a GMP deficiency letter following a UK MHRA inspection because they were not adequately assuring the quality of sub-contractors' work. We supplied an experienced quality assurance professional who worked for the client for three days each month and ensured that all work was carried out according to GMP and project requirements.
  
• A US-based client wished to carry out a clinical trial in Europe, using Investigational Medicinal Product manufactured in the US. We audited the manufacturers to ensure compliance with EU GMP requirements, and managed the import, labelling, Qualified Person certification and dispatch in accordance with the Clinical Trials Directive (2001/20/EC).
  
• We have carried out pre-audits of European manufacturers of Investigational Medicinal Product prior to regulatory inspections for Manufacturers Licences. We were able to propose documentation systems to meet the requirements of the Clinical Trials Directive.
  
• We have carried out training programmes for clinical trial sponsors, to alert them to the GMP requirements of the Clinical Trials Directive

Glossary of Terms

View our glossary of terms relating to Pharmaceutical Quality Assurance & Good Manufacturing Practice -->