BCSCP Prep Questions With Correct
Answers
The intent of 797 chapter to prevent harm, including death from what five risks? -
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CORRECT ANSWER✔✔-1) microbial contamination [nonsterility],
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2) excessive bacterial endotoxins,
| | | |
3) variability from the intended strength of correct ingredients, 4) physical and
| | | | | | | | | | | |
chemical incompatibilities, | |
5) chemical and physical contaminants, and/or
| | | | |
6) use of ingredients of inappropriate quality.
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USP 797 2022 EM excursion investigational requirements (5 listed)? - CORRECT
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ANSWER✔✔-1. Investigate, take corrective action, and review effectiviness.
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2. Corrective action plan based on CFU # & microorganism.
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3. Extent of investigation based on deviation.
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4. Document corrective action plan.
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5. ID growth to genus if ID exceeded (microbiologist assist).
| | | | | | | | |
**No more mention of "highly pathogenic organisms"**
| | | | | |
Viable Air Sampling Frequency USP 797 2022 - CORRECT ANSWER✔✔-Category 1
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and Category 2 CSPs, this must be completed at
| | | | | | | |
least every 6 months.
| | | |
,Category 3 CSPs, this must be completed within 30 days prior to the
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commencement of any Category 3 compounding and at least monthly thereafter | | | | | | | | | | |
regardless of the frequency of compounding Category 3 CSPs.
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USP 797 (2022) provides guidance on the number of units required to be sterility
| | | | | | | | | | | | | |
tested for smaller batches, what is the number of units that meet this
| | | | | | | | | | | | |
requirement and how many units need to be tested? If the the number of units
| | | | | | | | | | | | | | |
are greater what guidelines need to be followed? - CORRECT ANSWER✔✔-If
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batch is 1-39 units then 10% rounded to the next whole number may be tested.
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If 40 or more units require sterility testing then refer to tables 2 and 3 in USP 71.
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According to USP 797 (2022) which CSPs are required to have endotoxin testing? -
| | | | | | | | | | | | |
CORRECT ANSWER✔✔-CSP that are compounded from nonsterile ingredients
| | | | | | | | |
and are assigned a BUD date that requires sterility testing.
| | | | | | | | |
Category 3 BUD date must be supported by what type of stability data? What are
| | | | | | | | | | | | | | |
the four elements of stability requirements according to USP 797 (2022) -
| | | | | | | | | | | |
CORRECT ANSWER✔✔-Stability data using a stability-indicating method (SIM),
| | | | | | | |
that distinguishes active ingredients from degradants and impurities. Four
| | | | | | | | |
elements:
1. Exact formulation from which stability data is derived.
| | | | | | | |
2. Same storage & container closure material composition as study.
| | | | | | | | |
3. Validated analytical method as described in <1225>
| | | | | | |
4. Facility must have documentation of study, including methodology, validation
| | | | | | | | | |
of method, SIM and results.
| | | |
,What conditions if any can a BUD be extended past those listed in the tables of
| | | | | | | | | | | | | | | |
USP 797 (2022)? - CORRECT ANSWER✔✔-Cannot be extended based on SIM
| | | | | | | | | | |
performed by organization or peer reviewed literature.
| | | | | |
Can be extended based on based on USP-NF monograph if followed exactly with
| | | | | | | | | | | | |
tests that are required.
| | |
Beyond-Use-Date (BUD) as described in USP 797? How is this time determined? - | | | | | | | | | | | | |
CORRECT ANSWER✔✔-The date, or hour and the date, after which a CSP must
| | | | | | | | | | | | |
not be used, stored, or transported.
| | | | | |
BUD is determined by the date and time from which the CSP compounding
| | | | | | | | | | | | |
started.
When is preparation of conventionally manufactured product considered out of
| | | | | | | | | |
scope of USP 797 (2022)? (name 3 requirements) - CORRECT ANSWER✔✔-1.
| | | | | | | | | | |
Prepared as a single dose. | | | |
2. For a single patient.
| | | |
3. Approved labeling specifies the diluent, the resultant strength, the container
| | | | | | | | | | |
closure system, and the storage time.
| | | | |
What are the 5 factors described in USP 797 (2022) that affect microbial risk? -
| | | | | | | | | | | | | | |
CORRECT ANSWER✔✔-1. Conditions of environment where CSP is prepared.
| | | | | | | |
2. Aseptic processing and sterilization method.
| | | | |
3. Starting components.
| |
4. Sterility testing.
| |
5. Storage conditions.
| |
, When are Point-of-care systems (like addEASE, ADD-Vantage, Mini-Bag Plus)
| | | | | | | | |
considered out of scope and when are they considered in scope of USP 797
| | | | | | | | | | | | | |
(2022)? What determines BUD dates when they are in scope? - CORRECT
| | | | | | | | | | | |
ANSWER✔✔-Out of scope when docked and activated for immediate | | | | | | | | |
administration according to manufacturer instructions. | | | |
In scope when docked for future activation and administration - considered
| | | | | | | | | | |
compounding and must follow 797 except for BUD dates which default to
| | | | | | | | | | | |
manufacturer's labeling. |
What is the longest permitted BUD for Category 1? What environment can
| | | | | | | | | | | |
Category 1 be compounded? - CORRECT ANSWER✔✔-Controlled Room
| | | | | | | |
Temperature (20°-25°) <=12 h, Refrigerator | | | |
(2°-8°) <= 24h. SCA or Cleanroom suite.
| | | | | |
What are the longest permitted BUDs for Category 2 CSPs ASEPTICALLY prepared
| | | | | | | | | | | |
from one or more NONSTERILE starting component(s), when sterility testing is
| | | | | | | | | | |
NOT performed? - CORRECT ANSWER✔✔-Controlled Room Temperature (20°-
| | | | | | |
25°): 1 day
| |
Refrigerator (2°-8°): 4 days | | |
Freezer (−25° to −10°): 45 days
| | | | |
What are the longest permitted BUDs for Category 2 CSPs ASEPTICALLY prepared
| | | | | | | | | | | |
from only STERILE starting component(s), when sterility testing is NOT
| | | | | | | | | |
performed? - CORRECT ANSWER✔✔-Controlled Room Temperature (20°-25°): 4
| | | | | | | |
days
Refrigerator (2°-8°): 10 days | | |
Freezer (−25° to −10°): 45 days
| | | | |
Answers
The intent of 797 chapter to prevent harm, including death from what five risks? -
| | | | | | | | | | | | | |
CORRECT ANSWER✔✔-1) microbial contamination [nonsterility],
| | | | | |
2) excessive bacterial endotoxins,
| | | |
3) variability from the intended strength of correct ingredients, 4) physical and
| | | | | | | | | | | |
chemical incompatibilities, | |
5) chemical and physical contaminants, and/or
| | | | |
6) use of ingredients of inappropriate quality.
| | | | | |
USP 797 2022 EM excursion investigational requirements (5 listed)? - CORRECT
| | | | | | | | | | |
ANSWER✔✔-1. Investigate, take corrective action, and review effectiviness.
| | | | | | |
2. Corrective action plan based on CFU # & microorganism.
| | | | | | | | |
3. Extent of investigation based on deviation.
| | | | | |
4. Document corrective action plan.
| | | |
5. ID growth to genus if ID exceeded (microbiologist assist).
| | | | | | | | |
**No more mention of "highly pathogenic organisms"**
| | | | | |
Viable Air Sampling Frequency USP 797 2022 - CORRECT ANSWER✔✔-Category 1
| | | | | | | | | | |
and Category 2 CSPs, this must be completed at
| | | | | | | |
least every 6 months.
| | | |
,Category 3 CSPs, this must be completed within 30 days prior to the
| | | | | | | | | | | | |
commencement of any Category 3 compounding and at least monthly thereafter | | | | | | | | | | |
regardless of the frequency of compounding Category 3 CSPs.
| | | | | | | |
USP 797 (2022) provides guidance on the number of units required to be sterility
| | | | | | | | | | | | | |
tested for smaller batches, what is the number of units that meet this
| | | | | | | | | | | | |
requirement and how many units need to be tested? If the the number of units
| | | | | | | | | | | | | | |
are greater what guidelines need to be followed? - CORRECT ANSWER✔✔-If
| | | | | | | | | | |
batch is 1-39 units then 10% rounded to the next whole number may be tested.
| | | | | | | | | | | | | | |
If 40 or more units require sterility testing then refer to tables 2 and 3 in USP 71.
| | | | | | | | | | | | | | | | |
According to USP 797 (2022) which CSPs are required to have endotoxin testing? -
| | | | | | | | | | | | |
CORRECT ANSWER✔✔-CSP that are compounded from nonsterile ingredients
| | | | | | | | |
and are assigned a BUD date that requires sterility testing.
| | | | | | | | |
Category 3 BUD date must be supported by what type of stability data? What are
| | | | | | | | | | | | | | |
the four elements of stability requirements according to USP 797 (2022) -
| | | | | | | | | | | |
CORRECT ANSWER✔✔-Stability data using a stability-indicating method (SIM),
| | | | | | | |
that distinguishes active ingredients from degradants and impurities. Four
| | | | | | | | |
elements:
1. Exact formulation from which stability data is derived.
| | | | | | | |
2. Same storage & container closure material composition as study.
| | | | | | | | |
3. Validated analytical method as described in <1225>
| | | | | | |
4. Facility must have documentation of study, including methodology, validation
| | | | | | | | | |
of method, SIM and results.
| | | |
,What conditions if any can a BUD be extended past those listed in the tables of
| | | | | | | | | | | | | | | |
USP 797 (2022)? - CORRECT ANSWER✔✔-Cannot be extended based on SIM
| | | | | | | | | | |
performed by organization or peer reviewed literature.
| | | | | |
Can be extended based on based on USP-NF monograph if followed exactly with
| | | | | | | | | | | | |
tests that are required.
| | |
Beyond-Use-Date (BUD) as described in USP 797? How is this time determined? - | | | | | | | | | | | | |
CORRECT ANSWER✔✔-The date, or hour and the date, after which a CSP must
| | | | | | | | | | | | |
not be used, stored, or transported.
| | | | | |
BUD is determined by the date and time from which the CSP compounding
| | | | | | | | | | | | |
started.
When is preparation of conventionally manufactured product considered out of
| | | | | | | | | |
scope of USP 797 (2022)? (name 3 requirements) - CORRECT ANSWER✔✔-1.
| | | | | | | | | | |
Prepared as a single dose. | | | |
2. For a single patient.
| | | |
3. Approved labeling specifies the diluent, the resultant strength, the container
| | | | | | | | | | |
closure system, and the storage time.
| | | | |
What are the 5 factors described in USP 797 (2022) that affect microbial risk? -
| | | | | | | | | | | | | | |
CORRECT ANSWER✔✔-1. Conditions of environment where CSP is prepared.
| | | | | | | |
2. Aseptic processing and sterilization method.
| | | | |
3. Starting components.
| |
4. Sterility testing.
| |
5. Storage conditions.
| |
, When are Point-of-care systems (like addEASE, ADD-Vantage, Mini-Bag Plus)
| | | | | | | | |
considered out of scope and when are they considered in scope of USP 797
| | | | | | | | | | | | | |
(2022)? What determines BUD dates when they are in scope? - CORRECT
| | | | | | | | | | | |
ANSWER✔✔-Out of scope when docked and activated for immediate | | | | | | | | |
administration according to manufacturer instructions. | | | |
In scope when docked for future activation and administration - considered
| | | | | | | | | | |
compounding and must follow 797 except for BUD dates which default to
| | | | | | | | | | | |
manufacturer's labeling. |
What is the longest permitted BUD for Category 1? What environment can
| | | | | | | | | | | |
Category 1 be compounded? - CORRECT ANSWER✔✔-Controlled Room
| | | | | | | |
Temperature (20°-25°) <=12 h, Refrigerator | | | |
(2°-8°) <= 24h. SCA or Cleanroom suite.
| | | | | |
What are the longest permitted BUDs for Category 2 CSPs ASEPTICALLY prepared
| | | | | | | | | | | |
from one or more NONSTERILE starting component(s), when sterility testing is
| | | | | | | | | | |
NOT performed? - CORRECT ANSWER✔✔-Controlled Room Temperature (20°-
| | | | | | |
25°): 1 day
| |
Refrigerator (2°-8°): 4 days | | |
Freezer (−25° to −10°): 45 days
| | | | |
What are the longest permitted BUDs for Category 2 CSPs ASEPTICALLY prepared
| | | | | | | | | | | |
from only STERILE starting component(s), when sterility testing is NOT
| | | | | | | | | |
performed? - CORRECT ANSWER✔✔-Controlled Room Temperature (20°-25°): 4
| | | | | | | |
days
Refrigerator (2°-8°): 10 days | | |
Freezer (−25° to −10°): 45 days
| | | | |
