Quality Management and GMP Flashcards
(9 cards)
1
Q
What are the 5 Components of Quality Management in Pharmacy?
A
- Leadership and Culture
- Defining expectations/objectives and developing the service
- Standardising practice/process
- Quality Assurance
- Continuous Improvement
2
Q
5 Components of Quality Management in Pharmacy: What is meant by Leadership and Culture?
A
- Driving service that you provide
- Building capacity within team to reach a vision
3
Q
5 Components of Quality Management in Pharmacy: What is meant by Defining Expectations/Objectives and Developing the Service?
A
- Understand the needs of the service
- Know the users
- Know the standards
- Constraints on:
- Budgets
- Resources
- Space
- Equipment
4
Q
5 Components of Quality Management in Pharmacy: What is meant by Standardising Practice/Process?
How is this done?
A
- Breaking things down and making them more manageable
- Processes are constantly changing
- Help with training/problem solving
- Done by:
- Policies and Procedures
- Training/Competency tools
5
Q
5 Components of Quality Management in Pharmacy: What is meant by Quality Assurance in Pharmacy?
A
- Making sure people are doing what they’re meant to be doing and that systems work the way we intend them to
6
Q
5 Components of Quality Management in Pharmacy: What is meant by Continuous Improvement?
A
- Proactively reviewing things with the intention that we can always do something better
- Isn’t set out by standards - what’s important to you as a department
- Implement new processes and starts cycle again
7
Q
What’s involved in Self Audits?
A
- Written SOPs
- Self inspection team
- Inspection
- Performed routinely
- Recommend corrective actions
- Set timetable for corrective actions
8
Q
What do self audits show?
A
- Compliance with GMP requirements
- In-house shortcomings
- Ways to improve
- Prepares for external audits
9
Q
What is the Plan Do Check Act cycle?
A
- Plan: Identify your problems
- Do: Test potential solutions
- Check: Study results
- Act: Implement the best solution
