site inspections

One of the potential pitfalls when preparing a product launch is planning for GMP inspections. An upside of recent events, is worksharing, leading towards a more globalised market. In this article Vikash Patel, ELC Group tells us more... Read more


To make better use of inspection resources, regulators in the European Union (EU) and the United States (US) have agreed to rely on each other’s inspections of manufacturing sites for human medicines on both sides of the Atlantic. Read more


Injectables manufacturer Symbiosis Pharmaceutical Services has reported a successful Medicines and Healthcare products Regulatory Agency (MHRA) inspection. Read more


The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued. Read more

Novasep has announced that the FDA successfully audited two of its European custom manufacturing sites in Le Mans, France and Leverkusen, Germany. FDA investigators audited the two facilities in June and July 2013. Read more