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ICH Release Draft Guidance Q13 ‘Continuous Manufacturing of Drug Substances & Drug Products’!

27 July 2021

Chemtrix is pleased to share that The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have released the draft guideline ICH Q13 titled 'Continuous Manufacturing of Drug Substances & Drug Products', for public comment.

In recent years, there has been a sharp increase in the use of small, modular plants for the development & production of pharmaceuticals, fine & specialty chemicals.  COVID-19, & its impact on supply chains, has further accelerated activity in this area, with Countries targeting Continuous Manufacturing as a way of addressing supply chain security.  Read more on small, modular plants & the use of Continuous Manufacturing in the production of the Pfizer-BioNTech COVID-19 vaccine

Despite significant advances over the past decade, Users of the technology have been keenly waiting for guidance to harmonise advice on accepted definitions of batch, state of control & other technical aspects of Continuous drug product & drug substance manufacture!

Endorsed by the Assembly in 2018, the new ICH Q13 guideline targeted:

  • Capturing key considerations to harmonise elements specific to cGMP
  • Allowing drug manufacturers to use flexible approaches to develop & implement Continuous Manufacturing for new & existing drug products & drug substances
  • Providing guidance to regulatory agencies & Industry on regulatory expectations for the implementation & assessment of Continuous Manufacturing, when applied to the manufacture of drug products & drug substances

Comprising of the main guideline & five annexes, the document covers different types of Continuous Manufacturing, including full continuous & batch / flow hybrid systems, together with regulatory considerations, aspects of control startegies & examples of managing disturbances.

Released as Step 2 of the ICH process, the Q13 EWG guideline is now available for public comment & regional regulatory review.  We look forward to seeing how the public consultation on this document goes!

Curious how to Define a Batch for a Continuous Process?

Contrary to what people often think, the ICH Q7 definition of a batch is applicable to Continuous Manufacturing.  ICH Q13 draft guideline reaffirms this for both drug product & drug substance.  On the basis of the existing definition, the size of the batch for Continuous Manufacturing can be defined on the basis of one of the following:

  • Quantity of output material
  • Quantity of input material
  • Run time at a defined mass flow rate

The guideline also states that other 'scientifically justified' approaches will also be considered.

An important aspect of the guideline is the statement that 'a batch size can also be defined as a range'.  For example, a batch size range can be established by 'defining a minimum & maximum run time'.  This aspect is essential for those products where demand may need to be ramped-up or -down. 

Interested to know more?  Access the complete 44 page Draft Guideline here.

Don't forget, you can always contact us with your questions!

About Chemtrix
Chemtrix BV offers a scalable flow reactor portfolio that affords researchers & industrialists the tools required to harness the advantages of primary continuous manufacturing.  We combine expertise in the field of mechanical engineering, chemical engineering & chemistry to help our customers to benefit from the advantages that flow chemistry brings.  Our expertise enables us to offer scalable & flexible flow chemistry solutions, focussing on delivering our Customers higher profits by accessing new chemical possibilities via a safe & reliable scale-up from lab to production-scale.  Working closely with academia & industry, we work to change the way that chemical processes are developed & implemented.  Our global user base spans research institutes & government laboratories, to leaders in the fine chemical, specialty & pharmaceutical industries.

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