GCP
What does GCP stand for
Good clinical practice
What does GMP stand for
Good manufacturing practices
What does GLP stand for
Good laboratory practice
Why is documentation important
If it is not written down, it never happened
What does material control do
Controls the flow of materials in and out of the facility
Do you need to document everything that occurs
Yes
should you have an independent group make the final decision on a product? and why?
Yes, to avoid biases
What does PPE stand for? And include?
Personal protective equipment, may include:lab coat, gloves
What does QC stand for
Quality control
What does material control inspect
All materials and packaging
You should know what You’re supposed to do as you’re doing the lab? True or false
False
Ensure that there is______ and _______ over all processes
Consistency and control
Should you be aware of what your doing when in a lab setting
Yes
What does QC Demonstrate
It demonstrates product safety
Define procedure
Tells the operator what to do in chronological order
What does GCP assure?
Assurance that the rights, safety, and well-being of trial subjects are protected
What aspects of production do CGMP cover
all aspects of production, including starting materials, premise, equipment, training, and personal hygiene of staff
Which one of the following is not GLP:
DONT work alone
food is ALLOWED
WEAR your PPE
Food is allowed
What happens in QC
Testing of raw material, intermediate, and final product
Who approves all documentation and maintains files
Quality’s assurance