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RegisterRetention of Sample-USFDA [GxP / QC / QA]
Dear All
Need your feedback on the regulatory aspect.
What if the sponsor fails to provide the information about the in-vitro release test data for calculating retention quantity for USFDA BE studies and also fails to provide the upper limit of [300 units (test/reference each)] solid dosage-formulation?
Can a CRO retain the balance samples as suggested by the sponsor?
What if the CRO has raised the concern but the sponsor instructs to retain the balance IPs. Is the step okay? Which body (CRO/sponsor)will be responsible for the same? And what will be the regulatory concern?
Edit: Category changed. [Helmut]
Need your feedback on the regulatory aspect.
What if the sponsor fails to provide the information about the in-vitro release test data for calculating retention quantity for USFDA BE studies and also fails to provide the upper limit of [300 units (test/reference each)] solid dosage-formulation?
Can a CRO retain the balance samples as suggested by the sponsor?
What if the CRO has raised the concern but the sponsor instructs to retain the balance IPs. Is the step okay? Which body (CRO/sponsor)will be responsible for the same? And what will be the regulatory concern?
Edit: Category changed. [Helmut]
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Best regards
Rajdeep Mukherjee
Protocol Developer
Best regards
Rajdeep Mukherjee
Protocol Developer
Complete thread:
- Retention of Sample-USFDARajdeep 2010-10-19 12:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Retention of Sample-USFDA kapil pandya 2010-11-12 12:38
- Retention of Sample-USFDA Dr_Dan 2010-11-16 11:35
Ing. Helmut Schütz