Good manufacturing practice Flashcards
1
Q
Describe GMP
A
- GMP is a asystem for ensuring that prooducts are consistently produced and controlled according to quality standards
2
Q
Where is GMP applied
A
- PET radiopharmaceutical processing facilities
- Centralized radiopharmacies
- Hospital radiopharmacies
- Industrial radiopharmacieutical manufacturers
- pharmaceutical manufacturers
3
Q
Who regulates GMP in canada?
A
- Health canada
- Health products and GMP guideline book
- Health canada’s GMP regulations arein line with GMP standards from:
- WHO
- Pharmaceutical inspection cooperation/scheme
- internaitonal council on harmonization
- internation cooperation on harmonization of technical requirements for registration of veterinary medicinal products
- regulatory agencies in other countries
4
Q
What is included under GMP guidelines
A
- Essentially everything is regulated under the health products and food branch
- A GMP drug establishment license is issued by health canada
5
Q
Why is GMP important in RP production?
A
- To ensure the product is safe for humans
- protect patients, reduce health risks
6
Q
What products should have quality control performed on them
A
- Raw materials
- lab environment
- lab equipment
- final product
7
Q
Describe examples of GMP in general nuclear medicine
A
- Using aseptic techniques, documentation systems (NMIS), preparation of syringes in laminar flow hood, recording of temperature and humidity, following proper kit preparation procedures, equipment quality control and product quality control testing
