IPEC e-newsletter - Excipients Insight July/August 2018 - 31-08-18


Inside this issue


Work starts on ICH Q13 Continuous Manufacturing

At its meeting in Kobe, Japan, in June, the International Council for Harmonisation (ICH) agreed to start work on Guideline ICH Q13, intended to support support the introduction of continuous manufacturing into the pharmaceutical industry.

Work will now begin on developing formal concept papers and work plans, according to ICH, which has estimated that Q13 will take around three years to develop.

For decades, pharmaceuticals have been produced using batch manufacturing, a multi-step and often lengthy process. Recent advances in manufacturing technology have prompted the industry to consider moving away from batch manufacturing to a faster, more efficient process known as continuous manufacturing.

The transition to continuous manufacturing is still in its early stages, in part because start-up costs can be high, and for certain types of drugs such as biologics the technology to make them in this way is still in its infancy or absent. ICH hopes to help develop a set of harmonised definitions and scientific and regulatory concepts to help accelerate the shift. The pay off could be lower cost, faster production, higher quality and speed to market for medicines.




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