IMPG Subgroup Japanese Clinical Supplies TC April 11, 2005

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IMPG Subgroup - Japanese Clinical SuppliesTC
April 11, 2005
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Telecon of April 11, 2005

• Present
• Claudio Lorck, Fujisawa Germany
• Kilian Grassmann, Boehringer Ingelheim Germany
• Silvie Rassmussen, Eli Lilly, Belgium
• Markus Kiefer, Novartis, Switzerland
• Absent (but prediscussed)
• Simon Mann, Astra Zeneca, UK

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Topics of Interest

• Quality Standards
• Fill counts, overage,
• Visual appearance, defect criteria, quantiative
  acceptance criteria
• Datalogger request for shipments, transportation
  tests
• Additional samples (retain, regulatory, bulk
  back-up, acceptance testing)
• Cleanliness zone and gowning requirements
• Labelling
• Generation with japanese characters
• Inspection techniques
• Bookletts (providers, inspection, acceptability
  in Japan)
• Content requirements
• Locations (primary pack, visit pack, investigator
  pack)

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Topics of Interest contd

• Leadtimes
• Visual inspection practise (camera or manual,
  speed, cost)
• Local contract packagers
• Randomisation
• Role of external controller (3rd Party)
• Lead time
• Code breakers
• IVRS Distribution
• External warehouses at contractors/CROs
• Distribution process (Monitor involvement, 3rd
  party registration centers, courier services)
• Dosage form sizes
• Smaller tablet capsule sizes
• Comparators
• Procured locally/globally
• Negotiation with originator company

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Topics of Interest contd

• Company clinical strategy
• Japan develops local and apart from global
• Supply strategy for local japanese trials
• Japan is part of global development
• Supply strategy for global multinational trials
  including Japan
• Supply strategy for IVRS trials
• Distribution process from country depot to
  clinical site
• Analytical strategy
• JP rquirements included into global testing
  monograph
• Applicability to all product batches

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Topics of Interest contd

• Supply strategy
• Supply of bulk DP, packaging randomisation done
  in Japan
• Scope of acceptance testing, visual acceptance
  criteria
• Analytical release methods according to JP
• Preference for blisters, accetability of bottles
• Printed secondary packaging material
• Involvement of 3rd party for randomisation
• Supply of prepacked DP in blisters or bottles,
  secondary packaging in Japan
• Visual acceptance criteria (DP and primary packs
  ?)
• Scope of acceptance testing
• Involvement of 3rd party for randomisation
• Packaging and randomisation done outside Japan
• Supply of ready to use patient packs
• Scope of acceptance testing

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Topics of Interest contd

• Distribution to the patient
• Process for distribution to the clinical site
• Personal transfer handling by clinical monitor
• Applicability of courier services
• Storage at the clinical site
• Allocation process (involvement of 3rd party
  registration center)
• IVRS trials
• Returns
• Storage conditions

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Topics of Interest contd

• Regulatory CMC
• Changes after April 1st with new PAL and the
  option to submit large portions of the dossier in
  english (module 3 of CTD)

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Current Discussion Items

• Strategy Objectives
• Informal meetings via teleconference, exchange of
  experience
• Best practise objective setting (visual
  acceptance critera, ...)
• ......
• Members ?
• Need additional memebers
• From which company location is depending on
  strategy
• Point of view
• ROW outside of Japan wants to learn and also
  change development and supply strategies
• Japan is happy with their current standard and
  applies it also outside of Japan.