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Registerlight protection [Bioanalytics]
Dear All,
kindly advice on followings:
The COA of working standard containing note that the martial should be protected form light however during making solution there was no precaution taken to protect from light.
At the end of the validation it is found that all the stability are within the acceptance and during development also the same condition applied to the prepared solution.
Now is this acceptable or some other support is need be provided to the generated data. with addition to this we have tried to search any literature which contain the storage and usage of this material but we could not get any reference which specifies that the material is light sensitive.
Regards,
Auditor
kindly advice on followings:
The COA of working standard containing note that the martial should be protected form light however during making solution there was no precaution taken to protect from light.
At the end of the validation it is found that all the stability are within the acceptance and during development also the same condition applied to the prepared solution.
Now is this acceptable or some other support is need be provided to the generated data. with addition to this we have tried to search any literature which contain the storage and usage of this material but we could not get any reference which specifies that the material is light sensitive.
Regards,
Auditor
Complete thread:
- light protectionauditor 2011-12-27 08:14 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Ask the vendor! Helmut 2011-12-28 03:42
- Ask the vendor! auditor 2011-12-28 07:00
- Ask the agency! Helmut 2011-12-28 15:06
- Ask the agency! auditor 2011-12-31 12:37
- Delete any lines which are not specific to your reply! Helmut 2011-12-31 14:00
- Ask the agency! auditor 2011-12-31 12:37
- Ask the agency! Helmut 2011-12-28 15:06
- Ask the vendor! auditor 2011-12-28 07:00
- Ask the vendor! Helmut 2011-12-28 03:42
Ing. Helmut Schütz