26th APIC / CEFIC Global GMP & Regulatory API Conference
APIC's annual API conference is the most important forum for manufacturers of active pharmaceutical ingredients and the pharmaceutical industry. In 2023, the "26th APIC / CEFIC Global GMP & Regulatory API Conference" was once again held as a hybrid conference - in Berlin and online. This meant that participants and speakers from the API industry and international authorities were yet again able to discuss the latest developments on site. The increased focus of the topics on global cooperation, sustainability and common challenges in the area of marketing authorization and GMP-compliant manufacturing was also reflected this year's selection of speakers.
After the conference was opened by the then APIC President Hilde Vanneste, one of APIC's representatives, Luisa Paulo, who is now the new APIC President, led the participants and speakers through the morning of the first day of the conference in Berlin and online. The first presentation was given by Dirkjan van Zoelen, who was still working for Aspen Oss B.V. at the time of the conference. During his presentation "Development of second generation APIs" (see also Figure 1) he covered the following points:
Introduction to Aspen API
Testosterone
Etonogestrel
Impurity profile, fate & purge
Conclusion/Choice
Using selected examples and their original synthesis routes (first generation), he showed the possibilities for the development of socalled second generation APIs. He also outlined the factors required as well as the guidelines that apply. According to his assessment, second generation APIs offer great potential, particularly in the areas of sustainability and extending the life cycle of products.
The morning of the first conference day also included presentations by Hikage Shunin, PMDA, who presented the new approaches of the Japanese regulatory authority in his presentation "Update form PMDA", and Ibrahim H. Mujammami, SFDA, who highlighted the quality aspects of API documentation submitted in Saudi Arabia and the GCC countries. In addition, there was another presentation on the morning of the first day of the conference this year: The members of the APIC Task Force "Supplier Management" Gerold Haake, Siegfried PharmaChemikalien Minden, and Ricardo Mar tins, Vistin Pharma, presented the new APIC Guide "New APIC Guide on best practices for managing suppliers to API manufacturers".
Recommendation
Vienna, Austria23/24 October 2024
27th APIC/CEFIC Global GMP & Regulatory API Conference - in Vienna or online
Participants' questions and comments were always answered and discussed on site and online following the presentations, so that there was always a direct exchange on each topic.
After the lunch break, the participants of the "26th APIC / CEFIC Global GMP & Regulatory API Conference" were able to attend the first four parallel sessions online and on site, which were led by APIC representatives Rainer Fendt and Victoria Waddington, and choose from GMP and regulatory topics. These included the presentations "API stability studies", "Navigating the complexities of sterile injectable submissions", "How are health authorities inspections evolving in the world of APIs?" and "ICH M7 - Risk Assessment from API perspective". In line with this, all conference participants received the APIC M7 Task Force Guidance Document "Sharing Drug Substance M7 information to HA and MAH: "How to do" document" as a handout.
Fig. 1: Slide 27 of the presentation "Development of second generation APIs" by Dirkjan van Zoelen
The closing presentation "The role of the EDQM in protecting public health - current initiatives" of the first conference day was given by Nimet Filiz, EDQM, who presented the activities and innovations of the EDQM around CEP 2.0 and some selected monographs (e.g. nitrosamines, pyrogen testing, water for injection) and gave an overview of new initiatives of the EDQM.
The second day of the conference began with six practice-oriented parallel sessions, which again offered a diverse selection of topics. Depending on their areas of interest, participants were able to choose online and on site after each session which of the topic sections from the GMP and regulatory field they wanted to attend next. The presentations "How did COVID affect our API industry", "Quality Agreements: APIC Guidance and Templates" and "Revision of the ICH M4Q guideline: A Regulator's perspective" as well as the presentations "Digitalization in API", "The case for Quality Metrics" and "Recent breakthroughs in ANVISA API requirements and Emerging Markets novelties" were actively discussed.
After the lunch break, Ajda Podgorsek Berke, Lek Pharmaceuticals d.d., gave a presentation entitled "Nitrosamine impurities - Regulatory aspects and current standing" on the current situation regarding nitrosamines. Alex Viehmann, US FDA, who was connected online, also presented in the afternoon of the second conference day and gave an overview of the latest developments on the topic of "ICH Q9(R1)".
The presentation by ANVISA speaker Thaila Coradassi de Almeida received particular attention (see also Figure 2). Her presentation "Update from the ANVISA inspectorate" highlighted the following points:
ANVISA approval-related requirements for active ingredients
GMP certification for non-Brazilian API manufacturers
ANVISA's approach during the coronavirus pandemic
Deficiencies and their disclosure through ANVISA inspections
Fig. 2: Slide 8 of the presentation "Update from the ANVISA inspectorate" by Thaila Coradassi de Almeida, ANVISA
Recommendation
Barcelona, Spain6/7 November 2024
Handling Changes and Variations
Following the final Q&A session, Hilde Vanneste wrapped up the "26th APIC / CEFIC Global GMP & Regulatory API Conference" with her closing remarks.
Once again this year, the exchange between representatives from industry and authorities formed the core of this conference. The dedicated Q&A sessions at the event provided the perfect setting for this.
Note: The "27th APIC / CEFIC Global GMP & Regulatory API Conference" will take place from October 23-24, 2024 in Vienna. Highranking representatives from international drug regulatory authorities and the industry will report on the current quality and marketing authorization trends for active pharmaceutical ingredients and discuss current issues with you. This year, we will also be holding a hybrid conference so that you can choose how you would like to participate - online or on-site.
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.
