Originally Posted by
Raitess
Hi - all key activities should be traceable (EU GMP 4.8) and as you have already found you may need to prove what version of your SOP was in place at the time of an incident so retaining the versions of the SOPs that were in place at the time is necessary! EU GMP 4.12 covers the retention requirements but essentially it is up to you to define a Retention Policy that suits your needs and then ensures that secure controls are in place throughout the retention period (EU GMP 4.10).