

Information Request for Dendreon’s Pli - Provenge



 
To facilitate the upcoming PLI, please have the following information ready upon 
our arrival.
  List of names and titles of Dendreon attendees present at the opening and 
  closing meetings of the PLI. Provide us an electronic copy at the conclusion 
  of the PLI.
  List of names and titles of Dendreon employees we interview and the topics we 
  cover on a daily basis. Provide us an electronic copy at the conclusion of the 
  PLI.
  A brief presentation on facility and production updates since 2007.
  A brief presentation on firm’s Quality Systems.
  Detailed organizational charts.
  Detailed production schedule on a daily basis during the PLI, including 
  approximate start and finish time, and duration. We will have a brief 
  walk-through of the facility following the production logistics after the 
  presentation.
  Large, legible facility drawings/floor plans including room numbers and 
  functions.
  Large, legible diagrams illustrating AHUs, room classifications, pressure 
  differentials and flows (product, material, equipment, personnel and waste).
  Diagrams of manufacturing process flow, indicating in-process sampling points, 
  tests to be performed, specifications, and hold times.
  Copy of in-process and final product release specifications.
  Summary reports of annual and semi-annual media fill/aseptic processing 
  qualification since 2007.
  List of all SOPs, including titles, version numbers and approval dates, used 
  in production and QC testing.
  Summary reports of routine EM for all production areas since 2007, including 
  monthly, quarterly, annually/semi-annually reports, excursions, trending, 
  investigations, and corrective actions.
  Summary report of pressure differentials/temperature/humidity monitoring data 
  for manufacturing areas since 2007.
  List of all lots/batches manufactured at the NJ facility since 2007, including 
  the dispositions of those that have been discontinued and discarded.
  Batch records for all the batches manufactured at the NJ facility since 2007.
  List of all deviations/OOS, sorted by categories of major and minor, or 
  critical and non-critical, since 2007;
  List of all change controls, sorted by categories of facility, utility, 
  equipment, production, and QC, since 2007;

Please be prepared to provide information on or discuss the following issues:
  How manufacturing and testing is handled over to next shift and how 2nd shift 
  QA, QC, shop floor, and plant managers are appraised of manufacturing/testing 
  status from previous shift.
  Re-use of shipping containers, including examples of shipping containers 
  deemed unacceptable for continued use.
  Shipping experience at NJ facility
  Review batch records for lots made in new facility
  Training of physicians, apheresis, and infusion sites by Dendreon personnel
  Any product deviations
  Facility expansion plans
  Updated record keeping in QC lab
  New labeling system in QC lab
  Any additional or duplicate equipment added
  Speak with shop floor managers about logistics and oversight
  SOPs or other documentation that help prevent rushing manufacturing/testing to 
  meet deadlines
  Any data trending that has been done
 


