Comments on: Document Retention: Regulatory Guidance http://www.askaboutvalidation.com/document-retention-regulatory-guidance/ The World's No.1 Validation Forum Fri, 24 May 2013 04:13:36 +0000 hourly 1 http://wordpress.org/?v=3.5.1 By: Rahul kulkarni http://www.askaboutvalidation.com/document-retention-regulatory-guidance/#comment-2261 Rahul kulkarni Fri, 23 Nov 2012 14:55:10 +0000 http://www.askaboutvalidation.com/?p=52019#comment-2261 Thanks for Posting Useful information.

]]> By: DURGA PRASAD http://www.askaboutvalidation.com/document-retention-regulatory-guidance/#comment-1330 DURGA PRASAD Tue, 25 Sep 2012 13:43:13 +0000 http://www.askaboutvalidation.com/?p=52019#comment-1330 As per regulatory compliance you need hold minimum 1 year after expiry of such batches unless and otherwise you did not release these into markets.

Well stability Raw data and analytical reports that are concerned with the batches should remain as long as Batch records and Release controls remain at your Archival (Documentation room) either in a paper format or in a Approved Electronic format as per regulatory guidance.

Before you come to any conclusion you need to ask your regulators too.
If you are from India, I think your regulatory agency is not geared up to electronic formats. You need to take their consent before you archive your Batch record and associated documents in electronic format.

]]> By: Niraj Patel http://www.askaboutvalidation.com/document-retention-regulatory-guidance/#comment-1264 Niraj Patel Thu, 20 Sep 2012 14:25:55 +0000 http://www.askaboutvalidation.com/?p=52019#comment-1264 What is Ideal retention time for batch record of
1)PV Batch or exhibit batch (Formulation)
2)Stability batch (Formulation)
3)Stability raw data (HPLC/GC print out etc..)

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