Continuous manufacturing – regulators have different approaches
In the highly regulated pharmaceutical industry, manufacturers can’t help but wonder what regulatory authorities like the FDA think of emerging technologies. So what do the global authorities have to say about continuous manufacturing?
Technology for continuous manufacturing is relatively new to the pharmaceutical industry, but interest in continuous solutions and equipment has grown significantly within the last couple of years. This can be measured by the number of conferences, articles and case studies of pharmaceutical companies’ application of continuous processing for commercial use. However, there are some significant differences between global manufacturing trends and the approach of regulatory agencies.
As mentionedin a previous TechTalk article on continous manufacturing and the authorities, the US Food and Drug Administration (FDA) has been a strong proponent for a number of years. On the other hand, European agencies, including the European Medicines Agency (EMA), are positive
but do not actively promote it – or at least, not yet.
A brief history of regulators interest in continuous manufacturing
The FDA’s interest in continuous manufacturing dates back almost 15 years, when the first draft guidance on Process Analytical Technology (PAT) was published in 2003. This guide was the starting point of a significant paradigm shift for pharmaceutical regulations and worldwide good manufacturing practice (GMP). The International Council for Harmonisation (ICH) were particularly good at acknowledging this, with the US, EU and Japan describing the new paradigm in the guidelines of ICH Q8 for pharmaceutical development, Q9 for quality risk management and Q10 for the pharmaceutical quality System.