QUALITY CONTROL TESTS QUESTIONS & ANSWERS
What are characteristics of parenteral products? - Answers - Sterile
Pyrogen free
Particulate free
Stable
Isotonic
Is a sterility test alone acceptable to prove sterility of lot of CSP? - Answers - Not
according to USP
Is it possible to get a false positive on a sterility test? - Answers - Absolutely not
What is the FDA's position on sterility testing? - Answers - Good manufacturing practice
What are limitations of the USP sterility test? - Answers - Sampling assumes defects are
spread uniformly
Assumes media will support growth of organism
Contamination can occur during test
How long may freshly prepared media be stored? - Answers - 2 days. After this period
store between 2 and 25 C.
How long may unsealed media containers be used? - Answers - 1 month if growth
promotion is assessed within 2 weeks of usage
How long may tight media containers be used? - Answers - 1 year if growth promotion is
assessed within 3 months of usage
Is ready to use media acceptable for use? - Answers - Yes if it passes a sterility test and
growth promotion test
What activity of drugs in a CSP should be assessed to ensure reliability? - Answers -
Bacteriostasis and fungistasis
Why is a validation test necessary? - Answers - It is necessary to adjust experimental
condition of a sterility test of the product to ensure safety.
What media is used in the USP sterility test? - Answers - Fluid thioglycollate medium
(FTM)
Trypticase Soy Broth (TSB)
What kinds of organisms will grow in fluid thioglycollate medium? - Answers - Anaerobic
and aerobic bacteria
What are characteristics of parenteral products? - Answers - Sterile
Pyrogen free
Particulate free
Stable
Isotonic
Is a sterility test alone acceptable to prove sterility of lot of CSP? - Answers - Not
according to USP
Is it possible to get a false positive on a sterility test? - Answers - Absolutely not
What is the FDA's position on sterility testing? - Answers - Good manufacturing practice
What are limitations of the USP sterility test? - Answers - Sampling assumes defects are
spread uniformly
Assumes media will support growth of organism
Contamination can occur during test
How long may freshly prepared media be stored? - Answers - 2 days. After this period
store between 2 and 25 C.
How long may unsealed media containers be used? - Answers - 1 month if growth
promotion is assessed within 2 weeks of usage
How long may tight media containers be used? - Answers - 1 year if growth promotion is
assessed within 3 months of usage
Is ready to use media acceptable for use? - Answers - Yes if it passes a sterility test and
growth promotion test
What activity of drugs in a CSP should be assessed to ensure reliability? - Answers -
Bacteriostasis and fungistasis
Why is a validation test necessary? - Answers - It is necessary to adjust experimental
condition of a sterility test of the product to ensure safety.
What media is used in the USP sterility test? - Answers - Fluid thioglycollate medium
(FTM)
Trypticase Soy Broth (TSB)
What kinds of organisms will grow in fluid thioglycollate medium? - Answers - Anaerobic
and aerobic bacteria
