GMP - Radiopharmacy design

Question 1

Properties of an ideal radio-pharmaceutical

Answer 1

• Has no pharmacological effect on the patient

- Deliver the radionuclide to the ROI

Question 2

Types of radipharmacy

Answer 2

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

Question 3

Requirements of areas used for sterile prep

Answer 3

• maintains an appropriate cleanliness standard
• filtered air supply of an appropriate standard (HEPA filter)
• Accessed via airlocks for personnel / equipment and materials

Question 4

Types of sterilisation

Answer 4

• Terminal - post-production using heat (autoclave), ethylene oxide, irradiation
• Product is prepared aseptically

Question 5

Grades of cleanliness

Answer 5

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

Question 6

Cleanroom Design requirements

Answer 6

•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

Question 7

What is a URS - user requirement specification ?

Answer 7

Defines the specification for new facilities, systems or equipment. Includes essential elements of quality and steps to minimise any GMP risk.

Question 8

What is a DQ – Design Qualification?

Answer 8

A verification that the proposed design is suitable for the intended purpose.

Question 9

What is an IQ – Installation Qualification?

Answer 9

A document that verified that the installed equipment complies with the approved design.

Question 10

What is an OQ – Operation Qualification?`

Answer 10

Verification of the performance of installed equipment via an assessment of its upper and lower working limits using real or dummy products.

Question 11

What is a PQ – Performance Qualification?

Answer 11

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.