Sustainability in the API Industry - a hot topic of the "27th APIC / CEFIC Global GMP & Regulatory API Conference"
APIC's (Active Pharmaceutical Ingredients Committee) annual API conference is the most important forum for manufacturers of active pharmaceutical ingredients and the pharmaceutical industry. In 2024, the "27th APIC / CEFIC Global GMP & Regulatory API Conference" was the last time held as a hybrid conference - on-site in Vienna and online via stream. This meant that participants and speakers from the API industry and international authorities were yet again able to discuss the latest developments on-site and online.
The lectures and sessions of the conference were reflecting the hot topics and challenges of the API industry: Besides global co-operation in marketing authorization and GMP-compliant manufacturing, sustainability in the API industry was one of the most important topics of the two conference days in Vienna!
Sustainability in the API Industry
On Thursday morning, 24th October 2024, the speaker Guillaume Muller, who is working for Siegfried Evionnaz SA in Switzerland, gave the parallel session "Recycled raw materials in API manufacturing process for a greater sustainability". This parallel session was of great interest for the attendees and forced a lot of questions and discussions. Besides a case study and the relevant guidelines and regulations, the speaker presented the common practices for material recovery, catalysts and solvents. He explained that "Recycling materials in active ingredient manufacturing processes is a common practice - not only with solvents but also with other process-derived materials. Regulatory guidelines open the door to a range of possibilities, though they often lack detailed guidance." In his session he tried to answer and explain the questions like "What requirements must be met to ensure compliant material recycling? And what barriers are currently preventing our industry from becoming more sustainable? Finally, how can we pursue a path toward compliance and greater responsibility?" It was also announced that APIC is planning to introduce a new Task Force for the topic "sustainability", so that it is expected that updates and new information about this topic will be present during the upcoming conferences as well.
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Also, Joris Gilberts (see Figure 1), who is working for Aspen Oss B.V. in the Netherlands, presented a lecture, which focused on the topic sustainability. His talk was named "A sustainable API company: the long and winding road" and inspired the complete audience. The content of his lecture was focusing on the four following bullet points:
- Climate neutrality - reduce your footprint
- Circularity in API production: reality or fiction?
- Sustainability is more: Social and Governance topics
- How do we achieve these sustainability goals?
Figure 1: Joris Gilberts, Aspen Oss B.V., The Netherlands, at the "27th APIC / CEFIC Global GMP & Regulatory API Conference" in Vienna, Austria.
He mentioned as a summary of his talk the following: "In our journey towards a more sustainable future a lot of work needs to be done in making APIs more sustainable: using more circular materials, consuming less energy but also less resources in production processes. CEFICs Guideline for Safe and Sustainable by Design gives a good impression on how to deal with all the trade-offs between functionality, safety and sustainability. However, imagine the number of changes required to change all production processes and packaging materials! Regulatory and Quality people need to start to think of ways to accommodate that. How will we make it? Just do it. Show perseverance. Educate new generations." Finally, the speaker encouraged the audience to "act now" and start now with so called "appetizers" like "New packaging materials for APIs" and/or "Use of recovered solvents in API production".
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These two talks were accompanied by an interesting set of parallel sessions and lectures on both conference days, which were given by industry speakers, speakers of industry associations and speakers of authorities (EDQM, FDA, EMA) and completed the agenda of the hybrid conference in Vienna. The exchange of information between representatives from the industry and authorities formed the core of this conference. The Q&A sessions and discussions provided the perfect setting for this. And of course, once again a wellattended "Social Event" on Wednesday evening was one of the highlights of the conference.
Note: The "28th APIC / CEFIC Global GMP & Regulatory API Conference" and the ECA course prior to conference will take place from October 21-23, 2025 in Barcelona, Spain. High-ranking representatives from international authorities, associations and the API industry will report on the current quality and marketing authorization trends for active pharmaceutical ingredients and discuss current issues with you.
About the Author
Anne Günster joined CONCEPT HEIDELBERG in 2019 and organises and conducts courses and conferences on behalf of the ECA Academy in the areas API Manufacturing, Regulatory Affairs, Documentation and Laboratory Data Integrity.
