Quality Management, Safety, and Patient Compliance Part 3 Flashcards
1
Q
A QA program is a way to ____, ____, ____, and ____ all the aspects of compounding sterile preparations
A
monitor, evaluate, correct, and improve
2
Q
The QA plan should include a ____, which is provided to all personnel involved in compounding
A
formalized plan
3
Q
The plan should include ____s, which are detailed and include step-by-step instructions to guide a compounder through each procedure
A
SOP
4
Q
Per USP guidelines, the program should address:
A
Personnel qualifications and required training
Design and maintenance of the environment
Component selection and handling
Actual compounding processes
Final release of CSPs procedures
Documentation
