Abbreviations in QAA
FDA
What is the Food and Drug Administration?
Use safety SOPs for working with laboratory animals.
Safety SOPs must be used for working with animals.
A synonym for "to perform a test".
What is to carry out / to run a test?
The documentation required for all research processes and development steps ensures the ..................... of a drug.
What is traceability?
Protection covering the nose and mouth.
What is a face mask?
GDP
What is Good Documentation Practice?
Perform all work with virus-infected animals in the bio-safety cabinet.
All work with virus-infected animals must be performed in the bio-safety cabinet.
A verb meaning to finalize in "to ........... the inspection process".
What is to complete?
What is Endpoint testing?
Protection covering the hair.
What is a hairnet?
GLP
What is Good Laboratory Practice?
40,000 patients were taking the drug at the time of the recall.
The drug was being taken by 40,000 patients at the time.
A synonym for to call back
What is to recall?
The selection of some part of the manufactured product to check its quality.
What is product sampling?
A lightweight , usually white coat, worn to protect clothing when working in a laboratory
What is a lab coat?
GxP
What is Good Practice?
The European Medicines Agency (EMEA) should have required a thorough investigation of the manufacturing processes.
A thorough examination of the manufacturing processes should have been required by the EMEA.
A verb meaning to satisfy in "to ............... high standards."
What is to meet?
The issue of recurring failures to act in accordance with GxP.
After an audit, this is what corrective actions address.
What is non-compliance?
An outer shoe.
What is an overshoe?
QMS
What is Quality Management System?
They claimed the formulation of the drug was exactly the same. (clue: we do not know who)
It was claimed that the formulation of the drug was exactly the same.
A synonym for conform to in "Lab staff must ................. .................... GLP requirements"
What is comply with?
A piece of equipment to protect your eyes in the lab.
What are safety goggles?
Protective garments for your hands.
What are safety gloves?