B
I did a search and read the applicable threads, but I am still unclear on 21 CFR 820.180.
We have several devices on the market, all with a 2 year shelf life. Shelf life plus the 2 year requirement after commercial distribution plus a one year buffer equates to a quality record retention period of 5 years.
Our assumption:
Device specific quality records associated with, for example, Lots 1 thru 100 distributed in 2006 may be destroyed in 2012. Lots 101 thru 200 distributed in 2007 may be destroyed in 2013, etc.
Our question:
How does this apply to other quality records, such as audit reports, management review minutes, CAPA's, supplier audits, training records, etc.? Is the retention period for these types of records associated with specific devices or some other criteria. Or can we set a arbitrary retention period of 3 years?
Thanks!
Bob
We have several devices on the market, all with a 2 year shelf life. Shelf life plus the 2 year requirement after commercial distribution plus a one year buffer equates to a quality record retention period of 5 years.
Our assumption:
Device specific quality records associated with, for example, Lots 1 thru 100 distributed in 2006 may be destroyed in 2012. Lots 101 thru 200 distributed in 2007 may be destroyed in 2013, etc.
Our question:
How does this apply to other quality records, such as audit reports, management review minutes, CAPA's, supplier audits, training records, etc.? Is the retention period for these types of records associated with specific devices or some other criteria. Or can we set a arbitrary retention period of 3 years?
Thanks!
Bob