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Record of Telephone Conversation, May 3, 2010 - MenHibrix
Date/Time: 3 May 2010/0930
Organization: GlaxoSmithKline Biologicals
Representatives: Norris Pyle, Regulatory Affairs
Representatives: LCDR Sean Byrd, OCBQ/DMPQ/MRBI, HFM-675
Subject: STN 125363/0
GlaxoSmithKline Biologicals (GSK) submitted their original Biological Licensing Application on 12 August 2009 for their new product MenHibrix®. I contacted GSK to request the following information:
- For both lyophilized vaccine and diluent, please provide the location in the file where container closure integrity testing (CCIT) validation and product testing are found. If this information is not in the file, please submit it as soon as possible.
- Please confirm that the –b(4)- described in the CCIT validation submitted to the Hiberix file (this information was used to review the CCIT for the MenHibrix file as both container closure systems are identical) is the same used for the diluent in the Menhibrix file.
Response: they are the same.
- For the diluent, please provide the location in the file where validation of the 100% visual inspection can be found. This validation should cover definitions of Critical, Major, and Minor defects with their AQL/Acceptance Criteria. A rationale should be provided for how each type of defect was defined. The validation should also cover inspector qualification/training. I do note data provided on recent aseptic filling operations for the(b)(4) line are provided with data showing rejected –b(4)- for cracks and other defects, however without a valid AQL these data are meaningless.