Continuous Manufacturing From Vision to Reality: Continuous Manufacturing Has Come a Long Way
Author / Editor: G. Moelgaard about Trends in the pharmaceutical Industry / Anke Geipel-Kern
Continuous pharmaceutical manufacturing is becoming from vision to reality — More than ten years ago FDA supported continuous production in their 21th Century Initiative. Now future vision has becoming reality. Yet, some homework has to do, but the idea works.
“So before QbD becomes a forgotten term with no relation to manufacturing, we should start sharing the knowledge on where and how it is used in various companies.” Gert Moelgaard is Head of Strategic Development at NNE Pharmaplan, an engineering and consulting company focused on the life science industry
(Picture: NNE Pharmaplan)
Continuous pharmaceutical manufacturing has been a vision for more than 10 years and one of the signposts for the new generation GMP regulations that is based on the new regulatory paradigm based on the ICH Q8, 9 and 10 etc. guidelines.
Many pharmaceutical companies, and especially mid-sized companies, has considered it a manufacturing dream that could never come true, at least not in smaller scale production. The traditional pharmaceutical GMP regulations throughout the world required the batch-based manufacturing supply chain with quarantine QC testing and long waiting times between manufacturing step that made truly lean manufacturing almost impossible, compared to what is common in other industries.
From Vision to Reality
But the vision is becoming reality with active support from many of the pharmaceutical regulators, including the US FDA, that has been actively advocating continuous pharmaceutical manufacturing for many years now.
The recently formed Office of Pharmaceutical Quality even has as part of its vision that one example of new technology that FDA is encouraging is “continuous manufacturing”. Continuous pharmaceutical manufacturing offers potential flexibility, quality, and economic advantages over traditional processing methods.
Continuous Manufacturing Has Come a Long Way
The dream of continuous manufacturing started to arise a decade ago when several stakeholders, including US FDA, research institutions and a group of pharmaceutical companies formed several cooperation fora. The scope for this and several other initiatives was to enable new consensus standards and scientific basis for the future pharmaceutical quality management and manufacturing. The committee was formed in 2003, in the time when FDA announced the cGMP for the 21th Century Initiative and the guidance for Process Analytical Technology (PAT) and ICH the Quality Vision that led to ICH Q8, 9 and 10.
Unfold for details of your consent
Stand vom 23.03.2021
Naturally, we always handle your personal data responsibly. Any personal data we receive from you is processed in accordance with applicable data protection legislation. For detailed information please see our privacy policy.
Consent to the use of data for promotional purposes
I hereby consent to Vogel Communications Group GmbH & Co. KG, Max-Planckstr. 7-9, 97082 Würzburg including any affiliated companies according to §§ 15 et seq. AktG (hereafter: Vogel Communications Group) using my e-mail address to send editorial newsletters. A list of all affiliated companies can be found here
Newsletter content may include all products and services of any companies mentioned above, including for example specialist journals and books, events and fairs as well as event-related products and services, print and digital media offers and services such as additional (editorial) newsletters, raffles, lead campaigns, market research both online and offline, specialist webportals and e-learning offers. In case my personal telephone number has also been collected, it may be used for offers of aforementioned products, for services of the companies mentioned above, and market research purposes.
In case I access protected data on Internet portals of Vogel Communications Group including any affiliated companies according to §§ 15 et seq. AktG, I need to provide further data in order to register for the access to such content. In return for this free access to editorial content, my data may be used in accordance with this consent for the purposes stated here.
Right of revocation
I understand that I can revoke my consent at will. My revocation does not change the lawfulness of data processing that was conducted based on my consent leading up to my revocation. One option to declare my revocation is to use the contact form found at https://support.vogel.de. In case I no longer wish to receive certain newsletters, I have subscribed to, I can also click on the unsubscribe link included at the end of a newsletter. Further information regarding my right of revocation and the implementation of it as well as the consequences of my revocation can be found in the data protection declaration, section editorial newsletter.