RE: REMoxTB Importing - URGENT ... From: Matthew C. Betteridge ... View Contact To: Leonard Herbst ; ezekiel muinde ; "
[email protected]" ; Almarie Uys Cc: Almari Conradie ; "
[email protected]" ; Sue Bailey ; RemoxTB Trial Group ; Noeleen Pretorius
Dear Ezekiel,
I have reviewed the temp charts and can confirm that we have sufficient stability data to support the deviation recorded. All kits sent as part of your most recent shipment should be considered safe for use. Please go ahead and forward the CSPLs and I will in turn provide you with the corresponding study registers.
Any queries do let me know.
Kind regards,
Matt
Matt Betteridge REMoxTB Trial Manager MRC Clinical Trials Unit
Email to:
[email protected] Tel - +44 (0) 207 670 4812 Fax - +44 (0) 207 670 4829
From: Leonard Herbst [mailto:
[email protected]] Sent: Saturday, October 31, 2009 6:00 AM To: ezekiel muinde; Matthew C. Betteridge;
[email protected]; Almarie Uys Cc: Almari Conradie ;
[email protected]; Sue Bailey; RemoxTB Trial Group; Noeleen Pretorius Subject: RE: REMoxTB Importing - URGENT
Dear Ezekiel
Thank you very much for the temp charts and sending them so quickly to us.
I have noticed an excursion on the first charts of below 15dC, please keep these IMP quarantine until Matt has confirm that these can be used. Unfortunately I don’t have the stability data to provide the confirmation this will come from Matt on Monday. It looks to me that the chart was stopped on day 7 (page 2).
Can you please also forward us a copy of the signed CSPL for our files when you’re back on Monday? Thanks a lot.
Kind regards
Leonard
From: ezekiel muinde [mailto:
[email protected]] Sent: Saturday, October 31, 2009 6:52 AM To: Leonard Herbst Cc: Almari Conradie ;
[email protected]; Sue Bailey Subject: RE: REMoxTB Importing - URGENT
hi leonard
please find the attatched temperature slips for yesterdays IMP we recieved.
I apologise for the inconvenience caused.
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