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Dear All
Does anybody know of a guideline which mentions that QA should
observe spiking of QC's and CC's in plasma as part of inprocess check
or is it left to QA to decide?
Regards
Nilima Kalra
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The following message was posted to: PharmPK
HI Nilima,
In my opinion there is no guideline concerning QA in process audit
for spiking of QC's and CC's in plasma. Have you got any satisfactory
responses?
Regards,
manpreet
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hi
for the inprocess in lab you can set your parameter of process on
which you would like to in process activity.
for cc and QC in process only you can go through with the calculation
and serial dilution as it will be reflect in final out put.
regards,
paresh
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Dear All,
This is compulsory as a industry practice QA should observe spiking of
QC's and CC's in plasma as part of inprocess check and also to check the
calculations( dilutions) during preparation of QC`s and CC`s and report
this activity in QA audit report.
Thanks and Regards,
Sundar. G
Deputy Manager - QA
Bioanalytical Research Laboratory
Clinigene International Pvt. Ltd. - A Biocon Company
20th KM Hosur Road
Electronic City P.O.
Bangalore - 560 100.
India
Phone:91 80-28082730,28082808
Fax: 91 80-7833356
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