From Vision to Reality: Continuous Manufacturing Has Come a Long Way

Continuous pharmaceutical manufacturing is becoming from vision to reality — More than ten years ago FDA supported continuous production in their 21th Century Initiative. Now future vision has becoming reality. Yet, some homework has to do, but the idea works.

Continuous pharmaceutical manufacturing has been a vision for more than 10 years and one of the signposts for the new generation GMP regulations that is based on the new regulatory paradigm based on the ICH Q8, 9 and 10 etc. guidelines.

Many pharmaceutical companies, and especially mid-sized companies, has considered it a manufacturing dream that could never come true, at least not in smaller scale production. The traditional pharmaceutical GMP regulations throughout the world required the batch-based manufacturing supply chain with quarantine QC testing and long waiting times between manufacturing step that made truly lean manufacturing almost impossible, compared to what is common in other industries.

From Vision to Reality

But the vision is becoming reality with active support from many of the pharmaceutical regulators, including the US FDA, that has been actively advocating continuous pharmaceutical manufacturing for many years now.

The recently formed Office of Pharmaceutical Quality even has as part of its vision that one example of new technology that FDA is encouraging is “continuous manufacturing”. Continuous pharmaceutical manufacturing offers potential flexibility, quality, and economic advantages over traditional processing methods.

Continuous Manufacturing Has Come a Long Way

The dream of continuous manufacturing started to arise a decade ago when several stakeholders, including US FDA, research institutions and a group of pharmaceutical companies formed several cooperation fora. The scope for this and several other initiatives was to enable new consensus standards and scientific basis for the future pharmaceutical quality management and manufacturing. The committee was formed in 2003, in the time when FDA announced the cGMP for the 21th Century Initiative and the guidance for Process Analytical Technology (PAT) and ICH the Quality Vision that led to ICH Q8, 9 and 10.