BCSCP PREP
QUESTIONS
WITH 100%
CORRECT
ANSWERS!!
Evatee 10/23/24 BCSCP
,BCSCP PREP QUESTIONS WITH 100%
CORRECT ANSWERS!!
The intent of 797 chapter to prevent harm, including death from what five
risks? 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)? 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 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? 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? 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)
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)? 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? 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) 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?
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? 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.
QUESTIONS
WITH 100%
CORRECT
ANSWERS!!
Evatee 10/23/24 BCSCP
,BCSCP PREP QUESTIONS WITH 100%
CORRECT ANSWERS!!
The intent of 797 chapter to prevent harm, including death from what five
risks? 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)? 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 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? 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? 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)
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)? 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? 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) 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?
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? 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.
