RE: finished product analysis Contribution from Vamshi written on 8/30/2010 at 15:21
Original contribution: finished product analysis written by Deepak Kheni on 8/30/2010 at 14:19) Deepak,
I've seen companies doing complete testing on unpacked product and partial testing on packed product and vice versa.
As far as I know, there is no clear guidance. If there are any experts please through in your opinion.
I you are performing complete testing on the finished product i.e. coated tablets, then perform at least partial testing on the packaged product. for example doing description, assay and loss on drying if necessary.
The criteria here is to ensure that the finished product remained "intact" throughout the packaging process. Before loading the product in stability you have to ensure that you are not loading a product that is already adulterated. It saves time, money and investigation would be easy if there are any product failure.
Good luck.
Regards,
Vamshi
RA-Associate
Tampa, FL
Answers to this contribution:
Answering this Contribution:
|
