The core GMP project team: Anja Greefe, Niels Holbeck, Marie Wittrock, Dirk Jarrens, Lisa Leben, Christian Wolff, Thilo Kaiser, Niclas Meyer, Florian Meyer, Stefan Keller, Thorsten Meyer and Peter Högenauer. Missing: Nathalie Seitz, Steffen Erichson and Jörg Brouwer. 

Since the successful inspection by the Department for Social Services on 15 and 16 June, the Brunsbüttel plant in Germany is one step closer to being GMP-certified and, therefore, to meeting the high requirements of "Good Manufacturing Practice" (GMP). GMP refers to measures that ensure the quality, efficacy and safety of an active substance during manufacture, testing and storage.

With this certification, Brunsbüttel can now produce the long-chain alcohol NACOL 22 in a GMP-compliant manner. The product is used as the active ingredient "docosanol" by a company in the pharma industry in a lip herpes ointment. The production process, the native fatty alcohol (NFA) plant, the pastillation plant and the analytics were tested. Among other things, a GMP laboratory was set up in Brunsbüttel to ensure the quality of analysis results, which are also closely monitored by the authorities. The Marl plant has been GMP-certified since 2009. The 15-member core team that worked on the GMP certification project over the past 10 months under the leadership of Dr Thilo Kaiser benefited from this experience. The team faced hurdles and highlights along the way, as the project manager reports in the interview:

Mr Kaiser, what does it mean for the Brunsbüttel production plant to obtain GMP certification for the manufacture of NACOL 22 GMP?

T. Kaiser: GMP certification provides numerous advantages. With GMP-compliant production, we can meet current customer requirements, secure our location and gain market and competitive advantages. The GMP certificate is a legal requirement in the pharmaceutical market, and we expect that the demand for this certified product will increase and that we will be able to sell more products in the pharmaceutical sector. Other markets, such as the cosmetics market, will place higher demands on products, so an increase in demand is also possible here. All this means that this project is a good investment for the future and a very good pilot for us.

Dr Thilo Kaiser, GMP Project Manager

Were there any challenges with the GMP certification project?

T. Kaiser: One challenge was the fact that the project had been started and interrupted several times since 2009; this was accompanied by multiple changes in personnel in key functions as well as a scope expansion supported less than optimally by an external consultant. The resulting lack of consistency and, in some cases, considerable weaknesses in the basic documents repeatedly led to setbacks and a great deal of pressure to meet deadlines.

How do you and your team deal with this?

T. Kaiser: Systematic processing with our new consultant and the good practical support from our colleagues in Marl, in line with the motto "Copy and adapt instead of redeveloping or inventing", nevertheless enabled us to successfully overcome these challenges. Not least because additional resources were mobilised.

Has there been a highlight in this project for you so far?

T. Kaiser: A special highlight was the good cooperation within the team as well as beyond the factory boundaries. In particular, the good collaboration with colleagues from Marl, who also have GMP certification, was a real help to us. I have never experienced this in such a way before.

What's next?

T. Kaiser: We are expecting written feedback from the authorities on the inspection in the next few days. We will then systematically work through the comments from this, as well as the verbal comments we received during the inspection, in consultation with the authorities. My expectation is that we will have the official GMP certificate in our hands by the end of the year. In late summer, acceptance by the customer will take place, followed by delivery.

Thank you for taking part in the interview.