One of the potential pitfalls when preparing a product launch is planning for GMP inspections. An upside of recent events, the FDA confirming that eight EU member states have at least equivalent capabilities as the FDA in performing GMP inspections, is worksharing, leading towards a more globalised market. In this article Vikash Patel, senior regulatory specialist for ELC Group, tells us more…
Mutual benefit
Most drug development teams know that apart from the various internal mechanisms that need to be navigated before product launch, there are obviously many external regulatory-driven mechanisms to steer through. One of these potential pitfalls is planning for GMP inspections, so as to ensure that the majority of markets are covered in the first wave of submissions, as well as subsequent markets that accept mutual recognition, normally wave two and three markets covering ROW territories.