Q13 Continuous Manufacturing of Drug Substances & Drug Products Guidance for Industry Released!

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

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 a batch, state of control & other technical aspects of Continuous drug product & drug substance manufacture!

Endorsed by the Assembly in June 2018 & adopted in November 2022, the new ICH Q13 guideline targets:

• Capturing key consideration 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 strategies & examples of managing disturbances.

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 reaffirms this for both drug products & drug substances.  On the basis of this existing definition, the size of a batch for Continuous Manufacturing can be defined on the basis of one of the following;

1. Quantity of output material
2. Quantity of input material
3. 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 products where demand may need to be ramped up or down.

Interested to know more?  Access the complete 46 page Guideline here or via our Downloads section.

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.  

About ICH 

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has the mission of achieving greater regulatory harmonisation worldwide to ensure that safe, effective and high quality medicines are developed, registered and maintained un the most resource efficient manner.  By harmonising the regulatory expectations in regions around the world, ICH guidances have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardised safety reporting and marketing application submissions, and contributed to many other improvements in the quality of global drug manufacturing.

As a founding regulatory member of ICH, the Food and Drug Administration (FDA) plays a major role in the development of each of the ICH guidances, which FDA then adopts & issues as guidance to Industry.