Certification Test: SOPs for Companies
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This is the Online Certification Test for the SOPs for Companies Training. This is an open book test with which you may use your Certification Training eBooks and your Company’s SOP document.
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Question 1 of 20
1. Question1 points
Who is the presenter?Correct
You are right.Incorrect
Question 2 of 20
2. Question2 points
Which Federal Agency regulates Dietary Supplements under DSHEA?
Question 3 of 20
3. Question2 points
Which of these words are among the 5 which describe the purposes of SOP / cGMP requirements?
Question 4 of 20
4. Question2 points
What “truthful and not misleading” claims about Dietary Supplements did DSHEA allow vitamin companies to make?
Supporting normal structure
Supporting normal function
Reversing health conditionsCorrect
Very good! You’ve been listeningIncorrect
Nutrients may claim to support the normal.
Question 5 of 20
5. Question1 points
Are companies required to train their staff in cGMPs?Correct
Revise your thinking.
Question 6 of 20
6. Question1 points
Are companies required to have written SOPs?Correct
Why are you here?
Question 7 of 20
7. Question1 points
Does DSHEA require a specific Statutory Disclaimer on each vitamin label?Correct
Right; it’s on every vitamin bottle.Incorrect
The Statutory “Not evaluated” by the FDA and “not intended” to diagnose, prescribe, treat or cure is on every vitamin bottle.
Question 8 of 20
8. Question2 points
Which of these are NOT among the top ten warnings issued by FDA at inspections?
Written Adverse Event Reporting procedures
Product master record
Question 9 of 20
9. Question1 points
Do the cGMPs require a “sell by” date on labels?Correct
No “sell by” or “Use by” or similar unless you can substantiate the length of time; better to use a “Manufactured Date”
Question 10 of 20
10. Question1 points
Are companies required to designate a QC Manager?Correct
So do you know who is the QC Manager?Incorrect
Are you the QC Manager?
Question 11 of 20
11. Question1 points
Can a company guaranty specific results for its products?Correct
Satisfaction Guaranteed! Not results.Incorrect
Results not guaranteed (unless you can prove to the satisfaction of the FTC that the guaranteed results are “typical” — and no company can meet that test, but consumer “satisfaction” can be guaranteed, since that is a subjective decision of the consumer and is the same as an unconditional guarantee.
Question 12 of 20
12. Question1 points
Can a company simply rely on its contract manufacturer to abide by cGMPs?Correct
The label-owner is the responsible party.
Question 13 of 20
13. Question1 points
What types of events must be reported to FDA?
All consumer complaints?
All serious adverse events?
All adverse events?Correct
There are very few AERs reported annually.Incorrect
If it’s serious, the FDA wants to hear about it.
Question 14 of 20
14. Question1 points
If the company receives and stores inventory must you keep a batch-identified log of all inventory as received?Correct
All products must be identifiable by batch on your records.
Question 15 of 20
15. Question1 points
Is the company required to keep a written record of all customer complaints?Correct
Complaint records required.
Question 16 of 20
16. Question1 points
Is the company required to provide FDA copies of each product Core Data Sheet in the event of an inspection?Correct
It’s best to keep these records in a special FDA Inspection File Drawer.Incorrect
Uh. Huh. N. G.
Question 17 of 20
17. Question1 points
On which label panel is the Supplements Facts box usually found?
Question 18 of 20
18. Question1 points
How long after the last distribution of a product must you keep copies of records?Correct
The two year rule applies here.
Question 19 of 20
19. Question1 points
Must all product ingredients be listed in the Master Manufacturing Record / Core Data Sheet? (Y/N)Correct
Why not? Labels must be “truthful and not misleading.”
Question 20 of 20
20. Question1 points
Are you required to make copies of all required records available to FDA inspectors upon request?Correct