RAID Topic

1233 Bulk Batch Holding Times

1234 Shipment of samples outside of Turkey for Testing
1164 Quality Approval / Release of Process Order Disp Qtys and BOM Changes
1163 SKU Change for Serialisation
1162 QO Approval Process Following GIP / GEP Transfers
1161 Additional Testing process for every 10th Batch
1160 Rejection with P Process
1159 Roles and Respons. Matrix
1158 Potency Management
1157 Sample Labels & ZPAKS to LIMS
1156 LIMS Approach
1138 API Potency - Dymanic Filler calculation
Owner
Soumya / Ronan
Soumya / Ronan
Manuf
Tony Commercial Team
Soumya / Ronan
Soumya / Ronan
Soumya / Ronan/Chris
Soumya / Ronan
Soumya / Ronan
Soumya / Ronan
Business / Core Lims
Manuf
Comment
Will Batch Expiration Dates Manage this process?
Need understanding of AS-IS Process
Assigned to Manuf Team
Assigned to Tony
ON HOLD until interco processes defined. TBD pending GIP / GEP T/fer approach
Deeper Dive is required on AS-IS
Deeper Dive with Procurement to agree Process
Request Matrix From Business
Based of latest info from Isil POTENCY_2 should cover all scenarios
Business decision on ZPAK in LIMS required
Call scheduled with Gillian / core LIMS
Assigned to Manuf Team
 Sampling Creation of Batch Book
Material Type / Scenario Responsible: Manual/System? Responsible:
Raw Material
Packaging Material
Imported Bulk Products
Manufactured Semi Finished
Manufactured Finished Packs
GIP - > GEP Transfers
GEP - > GIP Transfers
CMO Related Products
Product Transfered from PGS to Commercial Market
. Other Scenarios
Creation of Batch Book Results Recording Usage Decision / Disposition Creation of COA
Manual/System? Responsible: Manual/System? Responsible: Manual/System? Responsible:
Creation of COA
Manual/System?