The number of days that a newly opened bottle of deconahol expires from the date it is first opened
What is 16 days?
100
What "FIT" stands for
What is Facility Inspection Team
100
The minimum and maximum amount of time that a conductivity probe should be allowed to stabilize after adding the appropriate standard solution
What is 30 and 60 seconds?
100
The minimum and maximum time a loadsure element must be soaked in NaOH
What is 30 minutes and 2 hours
100
True or False. An FDA inspector is a public officer who has the power to arrest you if necessary.
What is True?
200
The maximum # of people in the Recovery airlock
What is 5 people
200
The number one FIT finding during inspections
What is incorrect labeling
200
Who I must ultimately contact if a drain foams and overflows onto the surrounding processing floor.
What is QA?
200
How much 50% NaOH that must be added to 1L of WFI to make a 2% NaOH solution
What is 26mL?
200
True or False. When the FDA issues a warning letter, it is ALWAYS sent to the CEO of the company
What is True?
300
The time required to flush a WFI drop before using
What is 15 seconds
300
For the following, the only thing not prohibited in bldg. 1 processing areas: Food, Animals, Nail Polish, Water, and Skirts
What is Water?
300
If a spill is greater than this square footage, SBM should be called to clean the spill
What is greater than 4 square feet?
300
How long material must sit in the airlock before it is transferred into a processing area after spraying down with alcohol
What is 5 minutes?
300
The FDA is a regulatory agency located under the Department of Health and Human Services. The Department of Health and Human Services is under this branch of the US government.
What is the Executive Branch?
400
The expiration date of a freshly made solution of NaOH
What is 6 months
400
I must do this AND wash my hands before I enter B1 if I own a pet rodent
What is change into clean clothes not exposed to rodents
400
What you must note before using a tempilstick to verify steam temperature
What is verify the expiration date on the tempilstick?
400
New/exposed plant dedicated shoes must be sprayed with_________ and allowed to sit for ________ minutes
What is sporacide for 5 minutes?
400
How you should ask answer an FDA inspector when questioned.
What is answer truthfully and concisely?
500
The correct gowning order to go into a level 2 processing area
What is remove/don booties, sanitize hands, don safety glasses, hair cover, frock, sanitize hands, gloves.
500
What each of the S's in 5S stands for
What is Sort, Straighten, Shine, Standardize, and Sustain
500
When placing any unit "Out of Service", the unit must have a status of "Dirty" except for these 4 systems
What are the CIP skids, WFI loops, NaOH tanks, and freeze thaw skids?
500
The appropriate time to put a WFI hose on the return side for cleaning and reprocessing.
What is when the WFI sanitization recipe is complete?
500
The Drug Price Competition and Patent Term Restoration Act allows generic drug companies to "piggy-back" off our clinical trial data and make generic versions of our drugs. This Act is also know as this.