Quote:
Originally Posted by jcc911
Some do and others just contract the work. Generics can be manufactured by anyone as long as they adhere to an OTC or other compendial monograph.
The problem with the audit reports is that it is only one side of the story or just the auditors perspective. If the auditor is trying to build a case, the they portray findings worse than actual. The biggest problem is that the new compliance officers do not consider logic and science when performing their audits and have the mentality that the manufacturer is guilty. So in that aspect, yes the reports can be exaggerated.
Beyond that what makes things worse is when the media tries to interpret these reports as they really do not understand them and their presention of the data to the public is grossly incorrect.
|
I have seen that certainly. But by and large the auditors are working off of a tick box agenda. Is it validated yes or no? Do you a written stability program yes or no? etc.
__________________
Si non potes inimicum tuum vincere, habeas eum amicum and ride a big blue trike.
"'Bipartisan' usually means that a larger-than-usual deception is being carried out."
|