Page 7 - Documentation and Records
P. 7
GMP Training – Documentation and Records by www.gmpsop.com
Publish new document
Register document
Distribute new document
Train and assess competence
Review and/or change document
Propose a change
SME, QA. user(s) assess proposal
Agree on update
Archive officially superseded version
Retain one official copy superseded version
GOOD TO KNOW - DOCUMENT RETENTION
The GMP rules require that all documents relating to batch manufacture,
testing and distribution must be held for at least one year past the expiry date
for the batch.
In practice, many companies retain these documents for longer periods in line
with their legal obligations.
GMP rules for control
GMP requires that documents have the following control features:
Title
Unique number
Copyright©www.gmpsop.com. All rights reserved
Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited.
Page 7 of 30
