Editorial: When does something become current GMP?

摘要

I was working with a pharmaceutical manufacturer recently, benchmarking existing operations with my perception of the state-of-the-art, and moving on to develop the fundamental requirements for a new manufacturing facility. The stimulation for the investment in this case was a combination of market opportunity, new product introduction, and that they were experiencing regulatory pressure for not having a fully up-to-date manufacturing asset base. This made me think about how we keep up-to-date, how to identify where good manufacturing practice (GMP) is going, and perhaps, more importantly, plan for future investment and change. It is a clear regulatory requirement to keep up-to-date, and the term I like to use is "we must take reasonable and responsible advantage of available technology, techniques, and best practice". This does not mean we need to be at the bleeding edge of a new technology that is unproven and unreliable. Our GMP objective in deploying a new technique or technology should primarily be focused on product quality and patient benefit/safety. More and more today we have to consider commercial aspects and of course health and safety and environmental protection.