12-14 September 2023
Back in 2018, the ICH had begun work on a guideline titled "CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS Q13". A draft was published in mid-2021. Now ICH has approved the final version.
The ICH Q13 guideline describes scientific and regulatory considerations for the development, implementation, operation and life cycle management of continuous manufacturing. Continuous manufacturing refers to the continuous feeding of input materials into a manufacturing process, the conversion of materials in the process, and the simultaneous removal of product from a manufacturing process. While this also applies to processes such as tableting or chromatography, what is meant here is the integrated approach, i.e., the combination of two or more unit operations. Process changes or fluctuations in a downstream process step control the upstream process steps in a corrective manner. A continuous process also generates batches, whereby batches can be defined, for example, by the quantities used but also by the runtime of the process.
The Guideline ICH Q13 can be applied to the manufacture of active ingredients and medicinal products (small and large molecules). It applies to new products (e.g. new drugs, generics, biosimilars) and the conversion of conventional batch production to continuous production for existing products. Aspects of development, GMP and regulatory affairs are addressed.
Like the draft, the final version is divided into two parts. Part 1 describes on still 15 pages more general regulatory considerations and gives important definitions. Very interesting is the second part, which in five annexes focuses on the continuous manufacturing of:
Specifically, the first four chapters describe details of process control, process equipment, process control and validation.
The final version of the Guideline "CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS Q13" can be found on the ICH website.