  


Record of Telephone Conversation, June 23, 2011 - MenHibrix

 
 
Submission Type: BLA Submission ID: 125363/0 Office: OVRR

Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine

Applicant:
GlaxoSmithKline Biologicals

Telecon Date/Time: 23-Jun-2011 04:00 PM Initiated by FDA? Yes

Telephone Number: norris.h.pyle@gsk.com, jody.a.gould@gsk.com

Communication Categorie(s):
1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary:
Regarding GSK's response to Item 86 of CR Letter

FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, DAVID STATEN

Non-FDA Participants: NORRIS PYLE, JODY GOULD

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

Dear Dr. Gould:

We are reviewing your responses to item 86 of our Complete Review Letter dated June 11, 2010, for Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine and have the following comments and information requests:
1.We do not agree with your proposal to submit the data on manually inspected lots of diluent as a Post Marketing Commitment. Please describe the procedure that will be used to perform the 100% manual inspection of the diluent and show in detail how your –b(4)-------------------------------------- is related to the process. Also, please submit data for the first lot using the –b(4)------------------------- of filled lots of diluent as an amendment to the file.
2.It is noted you use the AQL to either accept or reject a lot. The AQL is the “Manufacturer’s Risk” of rejecting a good lot; i.e. it is a business risk. Please define and submit your Reject Quality Level as the Lot Tolerance Percent Defect (LTPD) as it is the “consumer’s risk” of accepting a lot that is defective. Also, please submit the Operating Characteristic (OC) Curve; i.e. the plot of the percent defectives versus the corresponding probabilities of acceptance. In addition, please provide a justification for the current LTPD levels associated with critical and major defects.
3.Please provide your rationale for the AQL of Critical Defects as –b(4)--when it should be “accept on –b(4)-----------
4.We find the following statement confusing: “The current –b(4)------------------------------------ program will be completed with an ---b(4)-------------------------------------------------------- to identify and remove defective containers prior to AQL inspection and release.” Please clarify if defects rejected by the b(4) remain part of the follow-up ---b(4)----------------------.
5.Please note that the b(4) is not considered a qualified piece of equipment and no decisions on lot disposition should be made based on information collected by the -b(4)-. Once qualified, the data must be submitted as a CBE with data from product inspections and an indication that it will be used on diluent. However, if the b(4) is used only for the diluent and not reconstituted product, you may report your qualification as an annual report. Please comment.
6.Please provide your rationale for why liquid within the plunger stopper is considered a minor defect. Such fluid may be indicative of a container-closure integrity breach. Furthermore, if the diluent is terminally sterilized, this liquid could be an indication of a problem in the sterilization parameters/conditions. Please note that during shipment these plunger stoppers do move, and may contaminate the sterile region of the barrel. Please comment.
7.Please provide your rationale for why –b(4)--- particles visible to the naked eye are considered a minor defect. --- ------b(4)  
8.Please describe “needle protection damaged” and provide your rationale for why it is considered a minor defect.

We will be in contact with you shortly to schedule a teleconference between CBER and GSK representatives to discuss these issues further. If you have any questions, please contact the Regulatory Project Manager, Kirk Prutzman, PhD, at (301) 796-2640.

Thank You.

Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
CBER/OVRR/DVRPA/CMC3
1451 Rockville Pike (WOC2)
Room 2241
HFM-481
Rockville , MD 20857
Phone: (301) 796-2640
