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QC SOPs - Coggle Diagram
QC SOPs
QC-SOP-004
PSMA / Dotatate QC
One SOP for Ga Products :check:
Two logbooks for each product :check:
One register with two tabs for each of the products :check:
System Suitability Logbook :check:
Specific parameter for batches for TLC/HPLC and Endotoxin Testing to be included here :check:
QC-SOP-003
Prep of working solutions (Tc and Ga) :check:
Scope: all solutions for HPLC and TLC :check:
Covers ordering and receipt, preparation and disposal
Appendices contain instructions on the preparation
For the future: add explanation of each solution i.e. used for..... in testing.... would be helpful to explain the requirement to prepare fresh solvent tank solution for Dotatate :check:
QC-SOP-005
TLC analysis
Scope: how to use Scan Ram, how to use :check:
Remove prep of mobile phases as this is now in QC-SOP-003 :check:
QC-SOP-001
Tc-99m QC
Logbooks
QC-LOG-001a
SPECT QC Testing Logbook
The logbook is the first point where results are recorded. SOP needs to specify this, pass criteria needs to be cross-referenced and made readily available
Split up QC Spreadsheet by product (also for historical data)
QC Spreadsheet added as controlled REG and locked down (formatting, editable fields, etc)
pH issue needs to be resolved from a data integrity point of view
QC-LOG-001b
PET QC Logbook :green_cross:
Each row covers both PSMA and Dotatate
Does not include endotoxin results
Ga QC SOP(s) need to state that first point of recording data is on the QC Testing Form (currently in MFR SOPs)
Consider individual logbooks for PSMA and Dotatate
Create a REG for Ga-68 products with separate tabs for products
EQP-SOP-013
HPLC use for Ga-68 Products
Troubleshooting guide :check:
EQP-SOP-015
Endosafe
Specific product parameter to be moved to QC-SOP-004 :check:
MFR-SOP-045
PSMA Manufacturing SOP
Contains QC cert :check:
MFR-SOP-047
Dotatate Manufacturing SOP
Contains QC cert :check:
EQP-SOP-006 (Use and Operation of Laura 6) :check: