The FDA holds virtual biotech companies accountable for the clinical trials they sponsor. If a…
We’ve made a number of changes to the Master Production
Records. Here you will find a great primer for everything coming in the latest
The status of an MPR is now in the leftmost column and MPRs
can now be approved or rejected. There are four statuses: Approved, Locked,
in-Progress, and Rejected.
Approved: All approvers have signed with their Approve signature
Locked: At least one Approve has been obtained and there is at least one more signature needed in order to complete the MPR. Changes cannot be made once it has been locked.
In-Progress: An MPR is in edit mode and no approver has signed
Rejected: At least one approver has signed with their Reject signature
Once an MPR has been approved, we’ve added some new options:
copy the MPR, version up, and scale up or down based on MPR structure rules.
It is now simple to duplicate an MPR by clicking on the copy
icon. The new copy retains all the information of the original, but everything
is editable. When creating a copy of an MPR, there has to be at least one
change made, whether it is product name; client; form ID; theoretical batch
yield; or batch unit.
With the MPR, you can now Version Up. As with copying an
MPR, only an approved MPR can be versioned up. New versions will retain their
product name, client, form ID, theoretical batch yield and batch unit. It is
mandatory to specify the reason for change.
Finally, the Bill of Materials quantity will automatically
auto-populate the manufacturing instructions. Any approved MPR is scalable up
The quantity to measure out will be shown on the BPR
manufacturing steps where inventory is selected. The system will calculate
conversions and keep a real-time update of the inventory.