6th APIC 2003

GMP News No. 428

1 December 2003

6th APIC2003

The 6th APIC/CEFIC European Conference on Active PharmaceuticalIngredients took place from 5-7 November 2003 in the Hilton Hotel Budapestin Budapest/Hungary on the Castle Hill in Buda, the medieval heart of theHungarian capital.

Nearly 200 participants from all over Europe participated in theconference that meanwhile has become the key event for the API industry inEurope. Speakers from API and Pharmaceutical Industry as well as fromorganisations and authorities from Europe, the US and Canada (among themDr. Moheb Nasr and Dr. Stephen P. Miller from CDER/FDA, Ms Corinne Pougetfrom EDQM, Dr. Mike Morris from Irish Medicines Boards, IMB, Mr JeanLambert from the Canadian Health Products and Food Branch Inspectorate,Dr. Peter Bachmann from the German Federal Institute for Drugs and MedicalDevices) presented actual GMP and RA topics.

As in the last years, the conference consisted of a GMP-part, a jointday and a Regulatory Affairs Part. The first and the third conference dayfocused on worldwide news in the GMP and the RA field related to the APIindustry. A new feature of the 6th APIC/CEFIC Conference onAPIs were different parallel sessions on 'How to do ICH Q7a' together witha final Round Table 'How to do' discussion with members of differentauthorities worldwide.

Dr. Henri Leblanc, President of the APIC (Active PharmaceuticalIngredients Committee) opened the conference on Wednesday, 5 November2005, followed by Mrs Gabriella Détari, Hungary, who gave the keynoteaddress and focused on the impact of the EU inlargement for the Hungarianpharmaceutical and API industry.

The GMP Part of the conference focused on worldwide GMP newsrelated to the API industry. Special attention was given on recentFDA/CDER initiatives (Risk based approach for GMP and CMC Review – PATand product characteristics for the 21st century; Dr. MohebNasr, CDER/FDA) as well as the answer of the API industry to the changingauthority environment. In particular the 6 Sigma Approach (Mr Rolf Staal,Aventis Pharma GmbH) as a vision and the Quality Management Systems (Dr.Lothar Hartmann, F. Hoffmann-La Roche AG) as a way to fulfil theauthorities' expectations were discussed. Furthermore, the currentsituation worldwide and trends in audits and inspections were presented,e.g. the IMI-PIC/S Inititative for ensuring API compliance (Mr JeanLambert, Health and Products and Food Branch Inspectorate, Canada) as wellas first experiences with the APIC Audit Programme (Dr. Barbara Jentges,Concept Heidelberg GmbH). Experiences and practical hints on how toprepare authority inspections and customer audits were presented (Dr.Reiner Kirrstetter, Aventis Pharma GmbH).

In the Joint Day, the new practical part of the conference,different parallel sessions for biotechnology (Dr. Harald Wiedner,QuaSyCon GmbH), computer related issues (Mr Willy Vervest, Omnichem NV/SAand Dr. Ralf Otte, ABB), cleaning validation (Ms Claudia Toobe,AstraZeneca, and Mr Stefan Gangkofner, Chemie Uetikon) and laboratoryequipment (including raw data handling; Dr. Peter Kammerer, Merckle GmbHand Dr. Uwe Plankert, F. Hoffmann-La Roche AG) with special focus on 'Howto do ICH Q7a' took place. Each participant had the opportunity toparticipate in two out of of 4 parallel sessions where specific topicswere presented and discussed in smaller groups together with specialistsfrom the API industry. A highlight of this part of the conference was theQuestions & Answers Section at the end of the day with a Round TableDiscussion with all authority members that participated the conference asspeakers.

The RA Part of the conference discussed worldwide RA newsrelated to the API Industry. The status of the CMC risk-based reviewproject, of BACPAC II and of the revision of the 1987 FDA Drug SubstanceGuidance (Dr. Stephen P. Miller, CDER/FDA) were presented. The reactionsof the pharmaceutical and the API industry to these initiatives werediscussed by members of the industry organisations PhRMA (Ms WendyMavroudakis, Johnson&Johnson, USA) and APIC (Ms Charlotte Hemmingsen,Alpharma Aps).

Furthermore, API related activities in 2003 and a forecast of 2004activities of CPMP/CVMP Quality Working Party (Dr. Mike Morris, IMB) wereexplained, special focus was given on the impact of the new EU VariationsRegulations on API manufacturers (Dr. Peter Bachmann, Federal Institute ofDrugs and Medical Devices, Germany) and their API aspects andinterpretations (Dr. Jan Smeets, DSM Anti-Infectives), on frequentdeficiencies in CEP applications (Ms Corinne Pouget, EDQM) and experienceswith CTD/eCTD related to APIs (Dr. Mike Morris, MBA). The RA part washighlighted by a presentation of Professor Dr. Holzgrabe (UniversityWürzburg, Germany), who presented her results of a research of differentGentamicin products to give an impression of the different API qualitiesavailable on the market.

The conference was marked very good by the participants, who enjoyedthe presentations and the discussions in the parallel sessions on the onehand and the opportunity to discuss special items with the authorityspeakers and the API Industry specialists personally.

Another highlight of the conference was the social event that meanwhilehas become a tradition and was well received. Participants and speakerswere invited to an entertaining evening outside the hotel followed by adinner in a typical Hungarian restaurant.


Dr Barbara Jentges

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