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RegisterA great idea [GxP / QC / QA]
Just sayin',
Assessment report template from CMD(h), updated long after the MV guideline was published, page 7 of 11:
Assessor's comment: Is the analytical method acceptable, validated (pre-study and within study), handling of samples adequate. Is there a statement on GLP compliance? Protocol deviations/violations? Are reasons for reanalysis of samples acceptable?
It ain't all easy to comprehend.
All this means to me that finding the right way through this ...erm... situation... implies that one must involve some degree of decision-making on basis of facts that are not in the public domain.
Is the template based on a semantic brilliancy - Perhaps they truly want compliance with GLP and GCP for bioanalysis but for some reason or other the CRO isn't supposed to actually spell out the latter?
I have a great idea. Why don't we include a standardised formulation in all reports, to replace all other compliance statements: "The bioanalytical part of this study was conducted in compliance with GCP and GLP, except GCP (where applicable)".
Less confusing, right?
You can thank me later.
❝ - BE trials: the BE guideline requires GLP compliance, and this has not been repelled by the publication of the BMV guideline. So: GCP + GLP + reflection paper.
Assessment report template from CMD(h), updated long after the MV guideline was published, page 7 of 11:
Assessor's comment: Is the analytical method acceptable, validated (pre-study and within study), handling of samples adequate. Is there a statement on GLP compliance? Protocol deviations/violations? Are reasons for reanalysis of samples acceptable?
It ain't all easy to comprehend.
All this means to me that finding the right way through this ...erm... situation... implies that one must involve some degree of decision-making on basis of facts that are not in the public domain.
Is the template based on a semantic brilliancy - Perhaps they truly want compliance with GLP and GCP for bioanalysis but for some reason or other the CRO isn't supposed to actually spell out the latter?
I have a great idea. Why don't we include a standardised formulation in all reports, to replace all other compliance statements: "The bioanalytical part of this study was conducted in compliance with GCP and GLP, except GCP (where applicable)".
Less confusing, right?
You can thank me later.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- GLP or GCP for bioanalysis? ElMaestro 2019-01-20 11:42 [GxP / QC / QA]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- GLP or GCP for bioanalysis? nobody 2019-01-20 13:47
- GLP or GCP for bioanalysis? ElMaestro 2019-01-20 13:54
- Both, Cap't'n ! Ohlbe 2019-01-20 23:11
- Both, Cap't'n ! ElMaestro 2019-01-21 09:42
- Both, Cap't'n ! nobody 2019-01-21 10:25
- Both, Cap't'n ! Ohlbe 2019-01-21 11:05
- Both, Cap't'n ! ElMaestro 2019-01-21 11:28
- Both, Cap't'n ! Ohlbe 2019-01-21 11:51
- Both, Cap't'n ! ElMaestro 2019-01-21 11:28
- A great ideaElMaestro 2019-01-22 22:39
- Statements of GCP and GLP compliance Ohlbe 2019-01-23 00:29
- Both, Cap't'n ! ElMaestro 2019-01-21 09:42
- Both, Cap't'n ! Ohlbe 2019-01-20 23:11
- GLP or GCP for bioanalysis? ElMaestro 2019-01-20 13:54
- GLP or GCP for bioanalysis? nobody 2019-01-20 13:47
Ing. Helmut Schütz