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RegisterRegarding Protocol Deviation [GxP / QC / QA]
Hi Bani.
In general there are two types of deviation, project specific deviation and SOP deviation.
When both protocols and SOPs are available for a procedure, the protocol takes precedence over the SOPs and any deviation from the SOPs will not be recorded as an SOP deviation if the study is in accordance with the protocol.
We need to specify the impact on quality of the deviation in the forms and CAPA can be applied for the deviation incoordination with the departmental heads.
Still further clarifications, kindly let me know.
Regards
Prashanth
In general there are two types of deviation, project specific deviation and SOP deviation.
When both protocols and SOPs are available for a procedure, the protocol takes precedence over the SOPs and any deviation from the SOPs will not be recorded as an SOP deviation if the study is in accordance with the protocol.
We need to specify the impact on quality of the deviation in the forms and CAPA can be applied for the deviation incoordination with the departmental heads.
Still further clarifications, kindly let me know.
Regards
Prashanth
Complete thread:
- Regarding Protocol Deviation Dr.Pravin 2009-02-12 10:25
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- Regarding Protocol Deviation Prashanth 2009-02-12 12:08
- Regarding Protocol Deviation Dr.Pravin 2009-02-12 12:54
- Regarding Protocol Deviation babun14 2009-03-05 12:42
- Regarding Protocol DeviationPrashanth 2009-03-05 13:15
- Regarding Protocol Deviation Prashanth 2009-02-12 12:08
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