Dear Forum Members:
Dr. Cundell promises to supply the answers.
Pharmaceutical Microbiology Quiz
1. Question: Place the following microbiological techniques in the order
of their discovery: a) serial dilution, b) most probable number * multiple
tube counts, c) membrane filtration counts and d) plate counts.
Answer: 1. a, b, c and d; 2. a, d, b and c; 3. b, a, c or d; 4. d, a, d and c
2. Question: When were current good manufacturing practices officially
Answer: 1. 1938; 2. 1992; 3. 1978 or 4. 1987
3. What organization under the Food, Drug and Cosmetics Act has the
authority to set the standards for microbiology testing.?
Answer: 1. Center for Drug Evaluation and Research, FDA; 2. Team
Biologics; 3. AOAC International or 4. The USP.
4. Question: The USP-recommended Air Cleanliness Guidelines are based on
what air sampler?
Answer: 1. STA; 2. Anderson; 3. RCS Plus or 4. Settling plates.
5. Question: What pharmaceutical dosage form is most susceptible to
Answer: 1. Liquid-filled capsule; 2. Topical ointment; 3. Inhalation
solution or 4. rectal suppositories
6. To qualify an incoming batch of Biological Indicators you need to do
Answer: 1. Verify the bioburden and identity; 2. Verify the D value; 3.
Verify the bioburden, identity and survival-kill times or 4. Verify the
7. Question: The antimicrobial effectiveness needs to be determined for
which of the following?
Answer: 1. Single-use containers; 2. Multiple-use containers, 3.
Multiple-use containers with preservatives or 4. All of the preceding.
8. Question: The methods for the microbiological testing of Purified
Water, USP may be found in which of the following?
Answer: 1. USP; 2. AOAC International; 3. CFR or 4. Standard Methods for
Examination of Water and Wastewater.
9. Question: What microorganism is most commonly found in non-sterile
products that were recalled from the market?
Answer: Aspergillus niger; 2. Bulholderia cepacia; 3. Ralstonia picketti
or Salmonella spp
10. Question: What are the growth-promotion requirements for sterility
Answer: 1. Every autoclave load of media; 2. No growth *promotion required
if you use a validated autoclave; 3. Every incoming lot of dehydrated media
or 4. Every incoming lot of dehydrated media if you use a validated autoclave.