Kim,
The CFR requires ID and assay at minimum, with certain materials having added special tests, i.e., glycerin. However, in your evaluation of each raw material, a determination must be made about certain parameters. These parameters are associated with concentration (water content) and degradants.
In my years, I have seen about 10 to 15% of raw materials failing these added tests, so a risk assessment must be performed to determine what tests should be performed routinely.
For large companies, they see the need to perform full testing on each shipment of material. Being in the South, we see a change in test results between summer and winter, especially with degradation formation. For instance, you have a truck in a parking lot during transport and the inside of that trailer may reach excessive temperatures, which tends to increase degradant formation.
Hope this helps,
Courtland
Sent from my iPhone
> On Jun 16, 2016, at 8:54 AM, Kim Huynh-Ba <[log in to unmask]> wrote:
>
> In your opinion, Once the vendor is qualified, do we need to do full USP
> testing for incoming API after received? or Could we just perform identify
> test to confirm.
>
> Thank you!
>
>
>
>
>
>
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The nature of this service is to provide a medium for communication. The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.
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The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community. Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
BahnsonEnvironmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration
Cincinnati Sub-Zero - http://www.cszindustrial.com/
Provides a large selection of environmental chambers from benchtop, reach in to walk-in
rooms along with chambers for freeze/thaw, temperature cycling applications.
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