Highlights of the 24th Active Pharmaceutical Ingredients Conference of APIC


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APIC's annual API Conference is the most important forum for API manufacturers and the pharmaceutical industry. In 2020, the conference took place as a live online event - as did the "24th APIC/ CEFIC Global GMP & Regulatory API Conference" in 2021. The increased focus on the topics of global collaboration in the field of regulatory affairs and GMP-compliant manufacturing was yet again reflected in the selection of speakers: representatives from the industry and from international authorities met online to receive first-hand information and to exchange views on current developments.

After the opening of the conference by APIC President Hilde Vanneste, one of APIC's representatives, Matt Moran, guided the participants and speakers through the first conference day.

The first day of the conference featured presentations by Lyle Canida, US FDA, on the QMM (Quality Management Maturity) programme, Rita Purcell, HPRA Ireland, on Brexit and Andrzej Rys, European Commission, on reshoring of production sites. In addition, Maggie Saykali, Cefic, presented the challenges and opportunities of European supply chains in the context of API production, especially in times of the Covid-19 pandemic.

As a special highlight of the first conference day, the presentation by Jennifer Sloan, Pfizer USA, must be mentioned. As was to be expected in advance from the name of the presentation ("Covid Vaccine - can the API Industry and Authorities learn from Speed from Concept to Patient Use?") it was very well received not only by the participants but also by the speakers and APIC representatives, which was evident in the large number of questions and comments.

Jennifer Sloan's presentation highlighted the success story of Covid- 19 vaccine production over the past months, which was characterised by the four key words "Courage", "Excellence", "Equity" and "Joy" (see also Figure 1). The fact that the point "Joy" also played a crucial role here and contributed significantly to the success became clear not only in the video shown by Jennifer Sloan on the applied and newly established supply chains - which would probably be impossible to establish under "normal circumstances".

ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation


Vienna, Austria1-3 July 2024

ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation

Figure 1: Slide 3 of the presentation "Covid Vaccine - can the API Industry and Authorities learn from Speed from Concept to Patient Use?" by Jennifer Sloan, Pfizer USA

Figure 2: Screenshot of slide 4 of the presentation "Update from ANVISA" by Renan Araujo Gois, ANVISA

As in the previous year, the first day of the conference ended with a final Q&A session and closing remarks by APIC President Hilde Vanneste.

The second conference day began with six parallel sessions, which were led by APIC representatives Rainer Fendt and Beate Miller. Participants were able to choose three topics from of the six practiceoriented sessions and change the online meeting rooms according to their fields of interest. As in previous years, these presentations were seen more as an exchange between speakers and participants and were peppered with surveys, in-depth questions and discussion rounds. The presentations on "Latest developments in nitrosamine impurities - impact on the API industry", "Regulatory hurdles and opportunities" and "China Drug Product regulatory process" attracted great interest, but the sessions on "Data Integrity: What's next", "Remote Audits - A concept for the future?" and "ICH Q13- Achieving regulatory harmonization for Continuous Manufacturing" were also well received.

In the afternoon, Hélène Bruguera, EDQM, presented the activities and innovations regarding the CEP procedure and inspection programme of the EDQM.

Special attention was given to the presentation "Update from ANVISA" by Renan Araujo Gois, ANVISA Brazil (see also Figure 2). In his presentation, he explained the new Active Pharmaceutical Ingredients (APIs) regulation (RDC 359/2020) of ANVISA and provided information about the contents of the DIFA (Active Pharmaceutical Ingredient Dossier) as well as of the CADIFA (Letter of Suitability of the Active Pharmaceutical Ingredient). After a general overview, the administrative points of the registration of active pharmaceutical ingredients in Brazil were listed and the challenges in this regard were pointed out. The transition periods until the mandatory use of the new registration process were explained in detail. Finally, the presentation included information on the stability studies required, GMP requirements and the handling of nitrosamine impurities.

The last day of the conference started with the presentation "The Importance of Workplace Wellbeing in the post pandemic world" by Sophie Moran, Ibec Ireland, and was accompanied by APIC representative Danny de Scheemaecker.

In addition to the topics "Digitalisation opportunities in API & GX-product development" and "Update on EAEU legislation", which were presented by Uros Klancer, Sandoz, and Ekaterina Bobrysheva & Arkadiy Gorozhanin, Sandoz, Marieke van Dalen, Aspen Oss, presented the complexity of international API supply chains and the challenges involved.

ICH Q7 Auditor Training Course


Vienna, Austria3-5 July 2024

ICH Q7 Auditor Training Course

Following the final Q&A session, Luisa Paulo, APIC Vice President, concluded the 24th APIC/CEFIC Global GMP & Regulatory API Conference with her closing remarks.

Once again, the exchange between representatives of industry and authorities formed the core of this conference. The dedicated Q&A sessions of the event provided a perfect framework for this.

Note: The "25th APIC/CEFIC Global GMP & Regulatory API Conference" will take place in Amsterdam on 26-27 October 2022. On the occasion of the 30th anniversary of APIC, highranking representatives from international drug regulatory authorities and industry will report on the current quality and regulatory trends regarding active pharmaceutical ingredients and discuss current issues with you. The ICH Q7 requirements and their implementation in the GMP environment will also be explained in detail and discussed in depth during the pre-conference session "ICH Q7 How to do - Document Hot Topics from the revised APIC guidance" on 25 October 2022.

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.

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