Housekeeping and Personal Hygiene
With the exception of water, which areas are not designated for Food and Beverage?
Production areas
Labs
True or False?
Black ink is the only acceptable color.
False
Blue or Black
Describe Critical Raw material
Critical: 100% inspected. Included in finished product formulation
Name 3 unacceptable accessories for production areas.
necklace
earrings
bracelets/watches
phones
Rings with stones
Finish the following sentence:
According to our customers and the FDA, if it was not documented......
It did not happen.
Who can a peer reviewer be?
A qualified inspector that did not perform the inspection.
Why is Housekeeping so important for GMP?
To eliminate possible contaminations and infestations.
Name the 3 things that are prohibited in GMP record keeping.
Erasures
Post-it notes
White out
Name 2 records use that we utilize for definitive proof.
Logbook
JDE
LIMS
What color of nail polish is allowed in Labs and production areas?
None
What are some acceptable abbreviations for GMP corrections?
TE (Transcription error)
CL (Clarity)
SE (Spelling error)
What does BDS and API stand for?
Bulk Drug substance and Active Pharmaceutical ingredient
Name a possible pest for manufacturing locations.
rodents
insects
Describe the correct way to correct a mistake.
Cross through with one line
abbreviation code
correction
initial
date
What quantity of sample is required for retains?
Amount needed to repeat all tests required for release, twice.