GMP - Radiopharmacy Design Flashcards
Properties of an ideal radio-pharmaceutical
- Has no pharmacological effect on the patient
- Deliver the radionuclide to the ROI
Types of radipharmacy
Unlicensed
- directly overseen by a pharmacist
- exempt from medicinces act 1968
- can only supply the trust
Licensed
- Operates under manufactuers specials license from MHRA
- Can supply other trusts
- Periodic GMP inspection by MHRA
Requirements of areas used for sterile prep
- maintains an appropriate cleanliness standard
- filtered air supply of an appropriate standard (HEPA filter)
- Accessed via airlocks for personnel / equipment and materials
Types of sterilisation
- Terminal - post-production using heat (autoclave), ethylene oxide, irradiation
- Product is prepared aseptically
Grades of cleanliness
Grade A - high risk operations / aseptic LAFC or isolator
Grade B - background for LAFC grade A
Grade C / D - background for an isolator
Grade U - uncontrolled area
Cleanroom Design requirements
•Validation Master Plan (VMP) documentation comprising:
– URS – User Requirement Specification
– DQ – Design Qualification
– FAT/SAT – Factory/Site Acceptance Testing
– IQ – Installation Qualification
– OQ – Operation Qualification
– PQ – Performance Qualification
What is a URS - user requirement specification ?
Defines the specification for new facilities, systems or equipment. Includes essential elements of quality and steps to minimise any GMP risk.
What is a DQ – Design Qualification?
A verification that the proposed design is suitable for the intended purpose.
What is an IQ – Installation Qualification?
A document that verified that the installed equipment complies with the approved design
What is an OQ – Operation Qualification?`
Verification of the performance of installed equipment via an assessment of its upper and lower working limits using real or dummy products.
What is a PQ – Performance Qualification?
Documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.
Using real or test product.
