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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request for Dendreon’s Pli - Provenge

To facilitate the upcoming PLI, please have the following information ready upon our arrival.

  1. 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.
  2. 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.
  3. A brief presentation on facility and production updates since 2007.
  4. A brief presentation on firm’s Quality Systems.
  5. Detailed organizational charts.
  6. 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.
  7. Large, legible facility drawings/floor plans including room numbers and functions.
  8. Large, legible diagrams illustrating AHUs, room classifications, pressure differentials and flows (product, material, equipment, personnel and waste).
  9. Diagrams of manufacturing process flow, indicating in-process sampling points, tests to be performed, specifications, and hold times.
  10. Copy of in-process and final product release specifications.
  11. Summary reports of annual and semi-annual media fill/aseptic processing qualification since 2007.
  12. List of all SOPs, including titles, version numbers and approval dates, used in production and QC testing.
  13. Summary reports of routine EM for all production areas since 2007, including monthly, quarterly, annually/semi-annually reports, excursions, trending, investigations, and corrective actions.
  14. Summary report of pressure differentials/temperature/humidity monitoring data for manufacturing areas since 2007.
  15. List of all lots/batches manufactured at the NJ facility since 2007, including the dispositions of those that have been discontinued and discarded.
  16. Batch records for all the batches manufactured at the NJ facility since 2007.
  17. List of all deviations/OOS, sorted by categories of major and minor, or critical and non-critical, since 2007;
  18. 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:

  1. 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.
  2. Re-use of shipping containers, including examples of shipping containers deemed unacceptable for continued use.
  3. Shipping experience at NJ facility
  4. Review batch records for lots made in new facility
  5. Training of physicians, apheresis, and infusion sites by Dendreon personnel
  6. Any product deviations
  7. Facility expansion plans
  8. Updated record keeping in QC lab
  9. New labeling system in QC lab
  10. Any additional or duplicate equipment added
  11. Speak with shop floor managers about logistics and oversight
  12. SOPs or other documentation that help prevent rushing manufacturing/testing to meet deadlines
  13. Any data trending that has been done