Housekeeping
Why is Housekeeping so important for GMP?
To eliminate possible contaminations and infestations.
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
Name 2 records of Equipment use that we utilize?
Sequence of use
Cleaning records
Maintenance records
Calibration records
What is our system for changes made to a procedure/process?
Management of change
What should you do if you notice leaky pipes within the plant?
Report instantly to superiors
Enter work order
Name 3 unacceptable accessories for production areas.
necklace
earrings
bracelets/watches
phones
Rings with stones
Name the 3 things that are prohibited in GMP record keeping.
Erasures
Post-it notes
White out
What quantity of sample is required for retains?
Amount needed to repeat all tests required for release, twice.
Why is change control important?
investigate bad products
protect customer
so to not repeat mistakes made
continual improvement
Name a possible pest for manufacturing locations.
rodents
insects
True or False?
Employees may use the pockets above the waistline to carry needed items.
False
Use of pockets above the waistline is prohibited.
What is a GMP requirement for packaging and labeling finished goods?
Area Clearance
Label Reconciliation
Name 3 reasons for holding a release and implementing investigations.
Out of specification results
Out of trend results
Process deviations
Raw material expired
Whose approvals are necessary for a change to happen?
Quality
Production
Engineering
Technical
SHE
Who monitors pest management for Henkel?
Sodexo
What color of nail polish is allowed in Labs and production areas?
None, without gloves
What are some acceptable abbreviations for GMP corrections?
EE (Error entry)
CE (Calculation error)
CL (Clarity)
SE (Spelling error)
Name the laboratory controls required for measurement, analysis, and improvement.
Lab records
Records of reagents and solution preparations
Use of reference reagents and standards
Is an unexpected process deviation subject to change control?
Yes
Needs to be NCMR'd
What type of documentation must be kept on pest control?
Record of inspection or treatment
Name 3 GMP requirements for restrooms?
Good repair/clean
Hot and cold water
Soap
Towels or dryers
Posted signs
Describe the correct way to correct a mistake.
Cross through with one line
initial
date
abbreviation code
Finish the following sentence:
According to our customers and the FDA, if it was not documented......
It did not happen.
Which document addresses when a customer is to be informed of a change?
Significant Change Guide (IPEC guide)