Good Manufacturing Practices Flashcards
1
Q
What does GMP stand for?
A
Good Manufacturing Practices
2
Q
What does CGMP stand for?
A
Current Good Manufacturing Practices
3
Q
What is GMP?
A
A system of processes, procedures, documentation that ensures products like food, cosmetics, and pharmaceuticals are consistently produced and controlled by quality standards.
4
Q
What are the 5 Ps of GMP
A
People, Products, Processes, Procedures, Premises
5
Q
What are the 10 principles of GMP?
A
- Create Standard Operating Procedures (SOPs)
- Enforce / Implement SOPs and work instructions
- Document procedures and processes
- Validate the effectiveness of SOPs
- Design and use working systems
- Maintain systems, facilities, and equipment
- Develop job competence of workers
- Prevent contamination through cleanliness
- Prioritize quality and integrate into workflow
- Conduct GMP audits regularly
6
Q
What are GMP standards?
A
GMP standards are developed to enhance the safety of manufactured products, especially pharmaceutical goods, and to ensure consumers get the highest quality possible.
7
Q
What are four measures you can follow to uphold GMP standards?
A
- Quality team
- Validation
- Surprise audits
- Compliance training
