FDA issues continuous manufacturing advice to build an agile pharma industry

On 1 March, the FDA issued the International Council for Harmonisation (ICH) final guidance on the use of continuous manufacturing  in drug production. This publication marks the FDA’s proactive steps to ease the pharmaceutical’s industry transition to these advanced processes, states the announcement. While not binding, the document covers the regulatory and scientific considerations needed for the development and implementation of continuous manufacturing in pharma, and the guidelines are meant for both new and pre-existing products.

This guidance was previously endorsed by the ICH Assembly in November 2022 and is regarded as an attempt to harmonise regulatory considerations surrounding continuous manufacturing. It adds to an overarching advisory framework established through other ICH guidelines.

For available products, the guidelines include considerations on the conversion of batch manufacturing practices to continuous manufacturing. Many pharmaceutical products are made through a step-by-step process known as batch manufacturing. Making a pharmaceutical product through this method involves multiple steps that are done over a longer period and across different sites. In contrast, a continuous method creates products in a consistent flow.  

In the last few years, continuous manufacturing was cited as a solution to address the ongoing challenges facing pharmaceutical supply chains. The Covid-19 pandemic had highlighted the difficulties surrounding global supply chains and the reliance on manufacturers in other parts of the world.

In a June 2021 report following an executive order, the Biden administration called for more public investment into continuous manufacturing. Funding was also given to companies that would bolster US-based production of critical medicines. This method of manufacturing has been also highlighted as a way to mitigate the industry’s environmental impact.

The document covers cover equipment design and process dynamics, among other topics, and features example of continuous manufacturing  systems used to produce therapeutic proteins and tablet drugs in its annexes. 

The guidelines also delve into quality control and process monitoring of continuous manufacturing. In one of the final sections, the document showcases some of the approaches than can be taken when managing disturbances that could affect material quality. Disturbances can harm the flow of a normal continuous operation and may result in a diversion of material.

In addition to the guidelines, the FDA shared a discussion paper on the implementation of artificial intelligence in drug production. However, this paper is not meant to offer recommendations, but instead will be used to source feedback from those in the industry. The deadline for comments on this topic is 1 May.

(Source: FDA)