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.
- 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