26/27 September 2023
On 22 June, it became official: the International Council for Harmonisation (ICH) announced in a press release that with the new Guideline ICH Q13, they would support the introduction of continuous manufacturing into the pharmaceutical industry. But what is this new document supposed to achieve?
ICH sees great potential in the introduction of continuous manufacturing for the pharmaceutical industry where efficiency and flexibility are concerned. However, they also realise that there is a great lack of general understanding for continuous processes, scientifically as well as in regards to regulatory concepts - this goes for the industry as well as the authorities. Another problem is the lack of global harmonisation, which is in turn considered to be slowing down the implementation of continuous manufacturing by the pharmaceutical industry.
According to ICH, the new guideline is supposed to offer key definitions as well as scientific principles and regulatory expectations (all from a quality perspective in a drug application). Control strategies and validation are both also mentioned. Furthermore, the new Guideline ICH Q13 is supposed to be consistent with the other ICH Guidelines (ICH Q8, Q9, Q10 and Q12).
ICH anticipates the development of the new guideline will require medium effort. Even if the concept of continuous manufacturing is relatively new in the pharmaceutical industry, the ICH's opinion is that FDA, MIT, ASTM, etc. have enough knowledge at their disposal. The knowledge of other industries such as the petrol or food industry regarding continuous processes may also be utilised.
ICH set a rough time frame of three years for the development of the new Q13 Guideline.