DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research
DATE: August 29, 2007
TIME: 2:00 PM
SPONSOR: GSK Bio
TO: File STN 125259/0
FROM: Gang Wang, Ph.D., CBER/OCBQ/DMPQ/MRB II, HFM-675
SUBJECT : Information Request
PARTICIPANTS: CBER: Gang Wang, Ph.D., Rebecca Olin, Robin Levis, Ph.D., Chiang Syin, Ph.D.
GSK: Terry Ward, Weining Hu, Linda Kramer
On August 29, 2007, we had a telecon with GSK to discuss some issues relating to the upcoming GSK’s Cervarix PAI. The following issues were discussed and communicated to GSK. Terry Ward, Director, US Regulatory Affairs for Vaccines Establishment at GSK, and Weining Hu and Linda Kramer from GSK were present in the telecon. Following the telecon, a written copy of the following information was emailed to Ms. Ward.
Administration related issues
- Date of PAI: Sept. 12 to Sept. 21, 2007;
- Flight schedules and hotel information:
- Arrival at Brussels, Belgium (BRU) on Sept. 10, 7:30 AM via UA 0950
- Departure from Brussels on Sept. 22, 12:10 PM via UA 0951
- We will be staying at Marriott Executive Apartments Brussels, Rue du Parnasse 15, Brussels, 1050 Belgium; Phone: 32-2-5052929, Fax: 32-2-5052555
- Transportation: The firm has agreed to provide assistance in transportation from the airport to the hotel on arrival and to the airport from the hotel on departure. Additionally, the firm will assist in providing transportation daily from the hotel to the manufacturing facility. We will arrive at GSK at 9 AM on Sept. 12 (Wednesday). We will pay the transportation cost by government credit card at the end of inspection.
- Daily lunch at Cafeteria or box lunches as needed.
- We will have daily close-out meetings and a final close-out meeting at the end of inspection.
- Please email or fax us a copy of your production schedule prior to the inspection.
- All documentations should be in English translation (an English summary for some of the documents may be fine).
Inspection related issues
- A 15 – 20 minute short presentation about the facility and the product;
- Walk through of the manufacturing and filling facilities;
- Copy of BLA submission as a reference;
- Copy of USP as a reference;
- Organizational charts;
- Large, legible facility drawings/floor plans/equipment locations, including room numbers;
- Production schedules for the inspection timeframe;
- Schematic diagrams of manufacturing process flow with information on the room and building numbers and facility sites;
- List of SOPs, both local and corporate, with titles, numbers and approval dates used in manufacturing of Cervarix;
- List of major processing equipment for Cervarix manufacturing with corresponding validation documents;
- List of computer systems for Cervarix manufacturing with corresponding validation documents;
- Summary report of routine environmental monitoring data for all Cervarix production areas dating from the initiation of consistency lot manufacture, including trending, excursions, analysis, investigations, and corrective actions, etc;
- Summary report of pressure differentials/temperature/humidity monitoring data for Cervarix manufacturing areas dating from the initiation of consistency lot manufacture, including excursions, investigations, and corrective actions, etc;
- Summary report of water and compressed air monitoring data for Cervarix manufacturing areas dating from the initiation of consistency lot manufacture, including trending, excursions, analysis, investigations, and corrective actions, etc;
- List of all deviations/out of specifications (OOS) and investigations associated with Cervarix manufacturing since Cervarix has been manufactured;
- List of all change controls associated with Cervarix manufacturing processes, equipment, utilities, and areas dating from the initiation of consistency lot manufacture;
- List of all lots/batches of Cervarix that have been manufactured to date, including all deviations/OOS occurred during manufacturing and investigations and current status;
- List of QC lab assays for Cervarix with corresponding validation documents;
- Product batch records for the consistency lots;
- Information on column and filter re-use and cleaning, and corresponding validation documents.
- Copy of your SOP for handling OOS and deviations;
- List of process deviations, including planned and unplanned, for all the lots of Cervarix made to date;
- A full report of the Cervarix filling deviation that was reported to us in your 8/28/07 email.