GMP - radiopharmacy quality systems Flashcards
1
Q
Pharmacy QC Quarterly
A
- Air sampling, both number, size and viability
- Surface swabs
- HEPA filter performance
- Air change rate
- Room pressure differentials
2
Q
Pharmacy QC weekly
A
- Settle plates
- Contact plates
3
Q
Pharmacy QC sessional grade A work
A
- settle and finger touch plates (finger dabs / glove check)
- Must have no CFUs.
4
Q
Operator competence checks
A
Aseptic Broth Trials
5
Q
Product checks
A
- Radionuclidic purity – Mo99 breakthrough
- Radiochemical purity – free Pertechnetate
- Sterility (retrospective)
6
Q
Equipment checks
A
RN calibrator tests – accuracy, constancy and (NPL) traceable (cross-)calibration
Generator QC - Mo 99 breakthrough and Al contamination check on first elution (and if moved).
7
Q
How is a broth check carried out ?
A
Samples are added to growth medium and incubated for 14 days, then checked for the presence of any CFUs
PASS = 0 CFUs
FAIL >= 1 CFU
8
Q
Who are the Key personnel in a radiopharmacy?
A
• Head of Production – aka Production Manager (PM) • Head of Quality Control – aka Quality Controller (QC) • Qualified Person (QP) – Only for Investigational Medicinal Products (IMPs) • QC and PM independent roles
9
Q
What is a CAPA?
A
Corrective Action Preventative Action report
Carried out following an incident, outlines the issue and the follow up taken.
10
Q
Requirements of Self inspection
A
- Monitor compliance with GMP - driver for improvement
- Regular intervals; pre-arranged program – typically in RP is done quarterly
- Independent of daily operations; external audits can be helpful
- Recorded, with proposals for Corrective Actions for improvement where required – Document actions taken
