Highlights of the 23rd Active Pharmaceutical Ingredients Conference of APIC

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For manufacturers of active pharmaceutical ingredients and the pharmaceutical industry, the annual APIC/CEFIC Global GMP & Regulatory API Conference is the most important forum. In 2020, this forum with the Pre-Conference Session on nitrosamine impurities took place live online for the first time. The conference specifically focused on the global orientation of GMP and Regulatory Affairs. Representatives from the industry and international authorities met online to obtain first-hand information and to exchange their views on current developments.

After the opening of the conference by APIC President Hilde Vanneste, two APIC representatives, Jens Brillault and Rainer Fendt, guided the participants and speakers through the online conference days.

At the beginning, Sandra Wens, Johnson & Johnson Pharmaceutical, Belgium, gave a detailed insight into the area of quality cultures - and provided possibilities and strategies how to efficiently and effectively implement them in everyday work and thus making routine processes more attractive.

A close look at the implementation of corporate strategies, including those of external partners, throughout the supply chain and their approaches to risk identification was demonstrated by Cathal O'Duinn, Janssen Pharmaceuticals, Ireland. He also emphasized the proactive use and sustainability of operational excellence (OPEX).

In the first presentation on the afternoon of the first conference day, Stefaan van de Velde, Ajinomoto Bio-Pharma Services, Belgium, clarified the life cycle approach in the field of process validation and its possibilities to minimize the validation effort. As usual, each speaker's presentation was followed by a detailed Q&A session, which was moderated and led by Jens Brillault and Rainer Fendt. Thus, the topics of the presentations could once again be covered and discussed from other perspectives. As the first authority representative, Rosimeire Pereira Alves da Cruz from Brazil's ANVISA reported on the API inspections of the Brazilian Medicines Agency and explained the process for obtaining and maintaining GMP certificates. In addition to the most common deficiencies in ANVISA inspections of API manufacturing sites, she presented the international collaboration of certifying authorities in the inspection collaboration programme.

Dieter Vanderlinden, Ajinomoto Bio-Pharma Services, Belgium, described in his presentation the risk-based approach to supplier management and highlighted the current practices and approaches of the pharmaceutical industry in this regard, in addition to the applicable GMP guidelines and requirements.

The first day of the conference was closed by Katherine Eban, USA, investigative American journalist and author, with her presentation "Fraud in generic pharmaceutical manufacture: A worldwide lifethreatening danger".

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The second day of the conference began with a presentation by Cristina Jiminez Sala, Sandoz, Spain. She reported on the regulatory challenges in the context of manufacturing and registration of sterile active pharmaceutical ingredients and the important collaboration between manufacturers and customers.

This was followed by a presentation of the drafted ICH 13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products. Nuno Matos, Hovione, USA, reported on the current status of the preparation and implementation of the guideline - which was in step 2a/2b at the time of the conference - and showed the advantages and possibilities of continuous manufacturing processes. Florent Trouillet, Siegfried, Switzerland, described the requirements and challenges for cleaning processes and methods in multipurpose manufacturing facilities. He showed how cleaning validation strategies and methods are developed and implemented based on risk analyses, and in which areas risk-based approaches can be helpful.

After the lunch break, three presentations dealt with the topic of nitrosamine impurities.

The first speaker was Robert Bream, EMA, Netherlands, who presented the latest developments and results in the field of nitrosamine impurities.

An overview of EDQM activities was provided by Hélène Bruguera, EDQM, France. In her presentation, she outlined the activities in the field of nitrosamine impurities, the measures taken due to the Covid - 19 pandemic and reported on news in the CEP certification and inspection programme.

Sabina Jurca, Sandoz, Slovenia, and Anthony Storey, Pfizer, United Kingdom, addressed the issue of nitrosamine impurities from the perspective of the pharmaceutical industry. They outlined the expectations placed on API manufacturers and marketing authorization holders with regard to GMP and regulatory compliance, and focused on the interdisciplinary co-operation required for this.

The second day of the conference was concluded by Sau (Lerry) Lee, US FDA, USA, with his presentation on the topic of continuous production from the FDA's perspective.

The final day of the conference began with a presentation by Frank Montgomery, AstraZeneca, UK, regarding the implementation of the ICH Q12 Guideline. He presented the guideline's contents and requirements and showed the resulting benefits for the pharmaceutical industry.

In addition to the basic principles of the guideline such as Established Conditions, Product Lifecycle Management (PLCM) document and Post-Approval Change Management Protocols (PACMP), he described how the guideline can be implemented and used through a practical example.

Ibrahim H. Mujammami, SFDA, Saudi Arabia, described in his lecture the approval procedures and GMP requirements for APIs in the Gulf States. He further presented the international co-operation and exchange between the authorities.

Following the first coffee break of the third day of the conference, Jeong-Ja Oh, Synex Consulting, South Korea, gave an insight into the South Korean DMF system and shared her experiences in dealing with API registrations in South Korea.

The impact of global API manufacturing on drug supply was presented by Adrian van den Hoven, Medicines for Europe, Belgium. He used the Covid - 19 pandemic as an example to highlight the challenges in this regard and mentioned other causes of drug supply shortages, such as the effects of Brexit or the serialization of packaging materials.

George Hartong van Lokven from Aspen Oss in The Netherlands gave a presentation on regulatory strategies and opportunities of APIs in Brazil, highlighting specifics in this regard. He drew a comparison from previous, current and subsequent requirements for approval procedures and compared them with the European system.

The Chinese registration system and its requirements were presented by Beate Miller, DSM Nutritional Products, Switzerland. She gave an insight into the Chinese pharmaceutical market from a regulatory perspective and shared the experiences of APIC members in the field of Chinese registration. She concluded her presentation with a case study.

24th APIC/CEFIC Global GMP & Regulatory API Conference - Three Conference Days - in Berlin or online

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Due to the great interest of the participants in the topic of nitrosamine impurities, an additional Q&A session including explanations was spontaneously held on Friday.

Following this final Q&A session, Hilde Vanneste closed the 23rd APIC/CEFIC Global GMP & Regulatory API Conference with her closing remarks.

Once again this year, the exchange between representatives of industry and authorities formed the core of this conference - with the dedicated Q&A sessions providing a perfect forum.

Note: The 24th 23rd APIC/CEFIC Global GMP & Regulatory API Conference will take place from October 26-28, 2021. High-ranking representatives from international drug regulatory authorities and industry will report on the current quality- and regulatory-related developments and news in the active pharmaceutical ingredients world - European wise and globally. Join the conference onsite in Berlin or live online at your screen!

 www.api-conference.org

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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