Assigning of retest period

TEMPLATES & PRESENTATIONS
1

Dear Forum

I had one product and retest period asigned for 36 months based on available stability data.

My question is “Retest period can be extended with reprocessing?”

Details are:

Manufacturing date: August 2010
Dispatch date: October 2010
Complaint received: January 2011
Reprocessed: March 2011

Final crystalization step repeated, No stability data available for extention of retest date.

Shall i assign fresh retest date from reprocess date? or Shall i consider from the manufacturing date [Molecule formation date].

Which one is suitable.

Quick response is highly appreciated.

Thanks and regards

2

in my opinion, retest date remains same as initial manufacturing. Batch to be kept on stability both accelerated and long term stability studies.