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RegisterQA Training: SOPs, protocol [GxP / QC / QA]
Dear Joshi,
Thanks for the elaborated response. Repeat analysis is of course a hot topic and attracts curiosity and we will take it up soon. Some labs want their MV protocols and method SOPs to be reviewed by QA to the extent that they wanted QA to sign it on the signature page and that does not appear to be right to me. They also want it to be done before they start using them. The GLP required QA to be very independent and QA should always be. Since they are drafted based on SOPs which are in line with GLP principles and FDA guidance to industry on MV and the operational staff of course should not be deviating, this looks to be as too much involment in the work. QA statement should suffice bec as per GLP we will give the details of what is audited and when.
Regarding training of all staff: QA i think shall ensure that the staff are trained in their areas where as the department head is responsible to abide by this dictum. And verify the training records or personnel while doing the documentation review for both clinical and bioanalytical work.
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Edit: Full quote removed - like in all your previous posts! Please see this post! [Helmut]
Thanks for the elaborated response. Repeat analysis is of course a hot topic and attracts curiosity and we will take it up soon. Some labs want their MV protocols and method SOPs to be reviewed by QA to the extent that they wanted QA to sign it on the signature page and that does not appear to be right to me. They also want it to be done before they start using them. The GLP required QA to be very independent and QA should always be. Since they are drafted based on SOPs which are in line with GLP principles and FDA guidance to industry on MV and the operational staff of course should not be deviating, this looks to be as too much involment in the work. QA statement should suffice bec as per GLP we will give the details of what is audited and when.
Regarding training of all staff: QA i think shall ensure that the staff are trained in their areas where as the department head is responsible to abide by this dictum. And verify the training records or personnel while doing the documentation review for both clinical and bioanalytical work.
--
Edit: Full quote removed - like in all your previous posts! Please see this post! [Helmut]
Complete thread:
- QA Training vish14184 2008-11-15 09:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- QA Training: SOPs, protocol Ohlbe 2008-11-15 13:16
- QA Training: SOPs, protocol chidambarajoshi 2008-11-17 11:08
- QA Training: SOPs, protocol vish14184 2008-11-18 09:12
- QA Training: SOPs, protocol mbshankar 2008-11-18 11:31
- QA Training: SOPs, protocol chidambarajoshi 2008-11-18 12:00
- QA Training: SOPs, protocol mbshankar 2008-11-18 12:43
- QA Training: SOPs, protocol chiragkhatri 2008-11-19 05:56
- QA Training: SOPs, protocol chidambarajoshi 2008-11-19 07:28
- QA Training: SOPs, protocol mbshankar 2008-11-19 10:43
- QA Training: SOPs, protocol chidambarajoshi 2008-11-19 11:45
- QA Training: SOPs, protocol chidambarajoshi 2008-11-19 11:47
- QA Training: SOPs, protocol mbshankar 2008-11-20 06:46
- QA Training: SOPs, protocol vish14184 2008-11-20 09:37
- QA Training: SOPs, protocol chidambarajoshi 2008-11-21 05:43
- QA Training: SOPs, protocolmbshankar 2008-11-22 05:09
- QA Training: SOPs, protocol chidambarajoshi 2008-11-24 11:22
- QA Training: SOPs, protocol mbshankar 2008-11-24 12:22
- QA Training: SOPs, protocol Ohlbe 2008-11-24 12:41
- QA Training: SOPs, protocol chidambarajoshi 2008-11-24 12:49
- LLOQ / Cmax Helmut 2008-11-24 12:54
- QA Training: SOPs, protocol mbshankar 2008-11-24 12:22
- QA Training: SOPs, protocol chidambarajoshi 2008-11-24 11:22
- QA Training: SOPs, protocolmbshankar 2008-11-22 05:09
- QA Training: SOPs, protocol mbshankar 2008-11-20 06:46
- QA Training: SOPs, protocol mbshankar 2008-11-19 10:43
- QA Training: SOPs, protocol chidambarajoshi 2008-11-19 07:28
- QA Training: SOPs, protocol chiragkhatri 2008-11-19 05:56
- QA Training: SOPs, protocol mbshankar 2008-11-18 12:43
- QA Training: SOPs, protocol chidambarajoshi 2008-11-18 12:00
- QA Training: SOPs, protocol mbshankar 2008-11-18 11:31
- QA Training: SOPs, protocol vish14184 2008-11-18 09:12
- QA Training: SOPs, protocol chidambarajoshi 2008-11-17 11:08
- QA Training: SOPs, protocol Ohlbe 2008-11-15 13:16
Ing. Helmut Schütz