10 Principles of GMP
This is the outcome of Line Clearance?
What is Cleanliness?
Any gloves worn in the CME Rooms need to be free of this material which may cause severe allergic reactions.
What is latex?
This is access given to a certain population?
What is controlled access?
This is why documentation is important in GMP.
What is traceability?
This is the scope of ISO 13485:2016.
What are Medical Devices?
This is the frequency of Line Clearance.
What is every batch/lot?
This is the purpose of gowning.
What is to prevent decontamination?
Scribbles, pre-recording data, "ditto" marks, down arrows and write-overs are these.
What are recording practices that are not allowed?
This is the role of training in GMP.
What is knowledge?
The FDA 21CFR has decided to merge with THIS standard in which all registered MedDevice companies must comply by 2026.
What is ISO 13485:2016?
This is performed at the beginning and end of every job.
What is Line Clearance?
The bouffant, coat, and booties must be removed in this order as they were put on.
What is the reverse?
This is the primary goal of GMP.
What is Quality?
This is the focus of ISO 13485:2016.
What is Quality?
This is the purpose of Line Clearance.
What is prevention?
After CE Rooms are compromised, this must be re-established before production can resume.
What is the controlled environment (particulate/viable testing may be required)?
This is how documentation is stored.
What is securely?
The term "GMP" stands for this.
What are Good Manufacturing Practices?
This the purpose of certification to ISO 13485:2016.
What is Compliance?
This colored bin indicates rejected material.
What is Red?
This is the frequency of monitoring the controlled environments.
What is daily/continuous?