Document retention time

(Ravi) #1

What is the guideline for retention of all type of documents like - Obsolete docs., Validation docs., BPR & BMR, Superseded docs., filled format / annexure/ register / log books etc.
plz guide

(bharat) #2

All production, control, and distribution records should be retained for at least 1
year after the expiry date of the batch. For
APIs with retest dates, records should be
retained for at least 3 years after
the batch is completely distributed.

(bharat) #3

When entries are made in records, these sh
ould be made indelibly
in spaces provided
for such entries, directly after performing
the activities, and should identify the
person making the entry. Corrections to
entries should be dated and signed and
leave the original entry still readable