Quality assurance of PET radiopharmaceuticals ensures patient safety and product efficacy through systematic activities implemented throughout the production process. This includes regulating raw materials, equipment, documentation, and product release. The batch record documents all production details for traceability. Products must meet criteria for purity, safety, and efficacy before release. Non-conforming products that fail quality control tests are removed and investigations are conducted to implement corrective actions. Quality is built into the production process through regulated procedures and cannot be tested in after the fact.

1. Quality Assurance of
PET Radiopharmaceuticals
“Training Course on PET Radiopharmaceuticals:
Production, Quality and Clinical Aspects”
21 – 24 April 2017
Cyclotron & Radiopharmaceuticals Department
King Faisal Specialist Hospital & Research Centre
M. Shoaib Shawoo, M.Sc.

2. What is Quality Assurance?
The planned and systematic activities implemented in a quality system so
that quality requirements for a product or service will be fulfilled.
Two key principles characterize QA:
 "fit for purpose“: the product should be suitable for the intended purpose
 "right first time“: mistakes should be eliminated

3. The Need For Quality Assurance
Quality cannot be “tested” into a product - it has to be
built-in;
Patient safety cannot be compromised – released
product has to meet the criteria for:
 purity;
 safety;
 efficacy
Sterility testing is NOT done before product release
Time is of the essence, especially in the case of
short-lived radiopharmaceuticals

4. Quality Assurance Functions
QA includes regulation of:
 all processes employed;
 quality of raw materials used;
 process and testing equipment;
 documentation required;
 documentation generated;
 dispatch of product

5. General Outline of Quality Processes
Related To FDG Production
QC QA PET
Issues Test
Forms to QC
Checks Batch
Record and Test
Results for
completeness
and accuracy
Issues Batch Record
and labels to PET
Tests the FDG Sample
CY
Sends Run
Request to CY
Returns the
completed Run
Request to PET
Produces isotope
as per request
Carries out
synthesis of
FDG
Sends test sample
to QC for testing
Assays and
dispenses FDG
as per orders
Completes the
Batch Record and
returns to QA
Transfers completed
Test Form with
results to QA
Releases the
product
Product is
shipped to
customer(s)

6. The Batch Record
Issued by the Quality Assurance Section
The batch record contains information pertaining to:
 Lot Number, Production, Calibration and Expiration Date/Time;
 Raw Materials used in production, for traceability;
 Some information related to Cyclotron operating parameters;
 The manufacturing procedure;
 Activity Produced;
 Labels Reconciliation;
 Operator

7. The Batch Record - Labels Control
Sample Labels on Page 1 of the Batch Record
Labels Reconciliation on Page 6 of the Batch Record

8. The Batch Record - Raw Materials Control
Details of all Raw Materials used on Pg 2 and 3 of the Batch
Record

9. The Batch Record - Calculations
Details of manufacturing procedure on Pg 3 and 4
Calculations and activity information on Pg 5

10. The Batch Record – Production Yield
Generated by the Synthesis Program
Useful information about the production yield

11. The Quality Control Test Form
Issued by the Quality Assurance Section
A typical F-18 FDG QC test form contains information pertaining to:
 Lot Number, Production, Calibration and Expiration Date/Time;
 Test specifications and results obtained;
 Operator

12. The Quality Control Test Form

13. Product Release and Dispatch
Product Release Sheet
Product Decay Curve

14. Control of Non-Conforming Product
Rework of FDG is possible only when:
 pH is out of specifications;
 Osmolality is out of specifications
Rework is done following validated and approved SOP
Sample is given to QC for re-testing
Appropriate documentation is completed
Incident is investigated and reported

15. Control of Non-Conforming Product
If product fails QC tests, (e.g. Radiochemical Purity below specifications):
 Product is immediately removed and stored for decay;
 Arrangements are made for production of another batch;
 Customers informed about the delay;
 Incident report is generated;
 Matter is investigated;
 Corrective / Preventive Action plan is devised

16. Order Processing (OP) Activities
OPA prepares Order List
and forwards to
Production Section
OPA (Order Processing
Assistant) receives
confirmed order from
Customer by Email
Production Staff dispenses
the product as per orders
Production Staff carries out
Packaging as per requirement,
and completes Order List
Radiation Safety Officer
inspects the packages
and updated the invoices
OPA also prints Invoices
and forwards to
Production Section
Packages are dispatched;
completed Order List and
Invoices are returned to OP

17. QUALITY DOES NOT BELONG TO
QUALITY ASSURANCE ALONE!