BCSCP Prep QUESTIONS &
SOLUTIONS
The intent of 797 chapter to prevent harm, including death from what five risks? -
ANSWER1) 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)? - ANSWER1.
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 - ANSWERCategory 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? - ANSWERIf 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? -
ANSWERCSP 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) - ANSWERStability
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)? - ANSWERCannot 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? -
ANSWERThe 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) - ANSWER1. 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? -
ANSWER1. 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? - ANSWEROut 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? - ANSWERControlled 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? - ANSWERControlled 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? -
ANSWERControlled Room Temperature (20°-25°): 4 days
Refrigerator (2°-8°): 10 days
Freezer (−25° to −10°): 45 days
What are the longest permitted BUDs for Category 2 CSPs ASEPTICALLY prepared,
when sterility testing is performed and passed? - ANSWERControlled Room
Temperature (20°-25°): 30 days
Refrigerator (2°-8°): 45 days
Freezer (−25° to −10°): 60 days
What are the longest permitted BUDs for Category 2 CSPs that have been terminally
sterilized, but sterility testing is NOT performed? - ANSWERControlled Room
Temperature (20°-25°): 14 days
Refrigerator (2°-8°): 28 days
Freezer (−25° to −10°): 45 days
What are the longest permitted BUDs for Category 2 CSPs that has been terminally
sterilized and a sterility testing is performed and passed? - ANSWERControlled Room
Temperature (20°-25°): 45 days
Refrigerator (2°-8°): 60 days
Freezer (−25° to −10°): 90 days
What are the longest permitted BUDs for Category 3 CSPs that has been
ASEPTICALLY processed, sterility tested, and passing all applicable tests for Category
3 CSPs? - ANSWERControlled Room Temperature (20°-25°): 60 days
Refrigerator (2°-8°): 90 days
Freezer (−25° to −10°): 120 days
What are the longest permitted BUDs for Category 3 CSPs that has been terminally
sterilized, sterility tested, and passing all applicable tests for Category 3 CSPs? -
ANSWERControlled Room Temperature (20°-25°): 90 days
Refrigerator (2°-8°): 120 days
Freezer (−25° to −10°): 180 days
ISO 5, 7, 8 Particle requirements and sample volumes? - ANSWERLimits 0.5 µm and
larger per m3, ISO 5: 3,520; ISO 7: 352,000; ISO 8: 3,520,000. Minimum of 1 minute
sample time and 2 liter volume of air.
Sterilizing Grade Membrane Requirement - ANSWERRetain 100% of cultures of 10^7
Brevundimonas (Pseudomonas) diminuta /sq cm of surface under not less 30 psi (1
bar). 0.2-0.22 µm
, USP 797 2022 Media Fill Incubation temperatures, durations and order of incubation? -
ANSWERIncubate the final containers at 20°-25° and 30°-35° for a minimum of 7 days
at each temperature band to detect a broad spectrum of microorganisms. The order of
the incubation temperatures must be described in the facility's SOPs.
USP 797 2022 Media Fill Frequency - ANSWERCategory 1 and Category 2 CSPs, the
aseptic manipulation competency must occur initially and at least every 6 months
thereafter.
Category 3 CSPs, the aseptic manipulation
competency must occur initially and at least every 3 months thereafter.
Immediate-Use CSP's Requirements 2022 (7 requirements)? - ANSWER1. Aseptic
techniques, processes, and procedures are followed, (written SOPs in place).
2. Personnel are trained and demonstrate competency.
3. Evidence-based information for physical and chemical
compatibility (e.g., approved labeling, stability and compatibility studies).
4. The preparation involves not more than 3 different sterile products.
5. Unused starting component from a single-dose container must be discarded and not
be used for more than one patient.
6. Administration begins within 4 h following the start of preparation, or else promptly
discarded.
7. Unless directly administered or witnessed by the preparer, the CSP must be labeled
(names, amounts of all active ingredients, name or initials of preparer, 4-h BUD)
Air Sampling Microbial Action Levels 2022 - ANSWERISO-5 is > 1, ISO-7 is > 10, ISO-8
or worse is > 100 (CFU /cubic m [1000 liters] air/plate).
Surface Sampling Microbial Action Levels 2022 - ANSWERSO-5 is > 3, ISO-7 is > 5,
ISO-8 or worse is > 50 (CFU /plate).
Required garbing order USP 797 2022 - ANSWERThe required garb, manner of
storage, and order of garbing must be determined by the facility and documented in the
facility's SOPs.
Component requirements for API selection (4 listed USP 797 2022)? - ANSWERWhen
APIs are used:
• MUST comply with USP-NF monograph, if one exists
• MUST have a COA that includes the specifications (e.g., compendial requirements for
quality) and that test
results for the component show that the API meets expected quality.
• In US, MUST be manufactured by an FDA-registered facility
• Outside United States, MUST comply with laws/regulations jurisdiction.
Requirements for all components OTHER THAN API selection (4 listed USP 797
2022)? - ANSWERMUST comply with USP-NF monograph, if one exists
SOLUTIONS
The intent of 797 chapter to prevent harm, including death from what five risks? -
ANSWER1) 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)? - ANSWER1.
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 - ANSWERCategory 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? - ANSWERIf 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? -
ANSWERCSP 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) - ANSWERStability
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)? - ANSWERCannot 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? -
ANSWERThe 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) - ANSWER1. 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? -
ANSWER1. 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? - ANSWEROut 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? - ANSWERControlled 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? - ANSWERControlled 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? -
ANSWERControlled Room Temperature (20°-25°): 4 days
Refrigerator (2°-8°): 10 days
Freezer (−25° to −10°): 45 days
What are the longest permitted BUDs for Category 2 CSPs ASEPTICALLY prepared,
when sterility testing is performed and passed? - ANSWERControlled Room
Temperature (20°-25°): 30 days
Refrigerator (2°-8°): 45 days
Freezer (−25° to −10°): 60 days
What are the longest permitted BUDs for Category 2 CSPs that have been terminally
sterilized, but sterility testing is NOT performed? - ANSWERControlled Room
Temperature (20°-25°): 14 days
Refrigerator (2°-8°): 28 days
Freezer (−25° to −10°): 45 days
What are the longest permitted BUDs for Category 2 CSPs that has been terminally
sterilized and a sterility testing is performed and passed? - ANSWERControlled Room
Temperature (20°-25°): 45 days
Refrigerator (2°-8°): 60 days
Freezer (−25° to −10°): 90 days
What are the longest permitted BUDs for Category 3 CSPs that has been
ASEPTICALLY processed, sterility tested, and passing all applicable tests for Category
3 CSPs? - ANSWERControlled Room Temperature (20°-25°): 60 days
Refrigerator (2°-8°): 90 days
Freezer (−25° to −10°): 120 days
What are the longest permitted BUDs for Category 3 CSPs that has been terminally
sterilized, sterility tested, and passing all applicable tests for Category 3 CSPs? -
ANSWERControlled Room Temperature (20°-25°): 90 days
Refrigerator (2°-8°): 120 days
Freezer (−25° to −10°): 180 days
ISO 5, 7, 8 Particle requirements and sample volumes? - ANSWERLimits 0.5 µm and
larger per m3, ISO 5: 3,520; ISO 7: 352,000; ISO 8: 3,520,000. Minimum of 1 minute
sample time and 2 liter volume of air.
Sterilizing Grade Membrane Requirement - ANSWERRetain 100% of cultures of 10^7
Brevundimonas (Pseudomonas) diminuta /sq cm of surface under not less 30 psi (1
bar). 0.2-0.22 µm
, USP 797 2022 Media Fill Incubation temperatures, durations and order of incubation? -
ANSWERIncubate the final containers at 20°-25° and 30°-35° for a minimum of 7 days
at each temperature band to detect a broad spectrum of microorganisms. The order of
the incubation temperatures must be described in the facility's SOPs.
USP 797 2022 Media Fill Frequency - ANSWERCategory 1 and Category 2 CSPs, the
aseptic manipulation competency must occur initially and at least every 6 months
thereafter.
Category 3 CSPs, the aseptic manipulation
competency must occur initially and at least every 3 months thereafter.
Immediate-Use CSP's Requirements 2022 (7 requirements)? - ANSWER1. Aseptic
techniques, processes, and procedures are followed, (written SOPs in place).
2. Personnel are trained and demonstrate competency.
3. Evidence-based information for physical and chemical
compatibility (e.g., approved labeling, stability and compatibility studies).
4. The preparation involves not more than 3 different sterile products.
5. Unused starting component from a single-dose container must be discarded and not
be used for more than one patient.
6. Administration begins within 4 h following the start of preparation, or else promptly
discarded.
7. Unless directly administered or witnessed by the preparer, the CSP must be labeled
(names, amounts of all active ingredients, name or initials of preparer, 4-h BUD)
Air Sampling Microbial Action Levels 2022 - ANSWERISO-5 is > 1, ISO-7 is > 10, ISO-8
or worse is > 100 (CFU /cubic m [1000 liters] air/plate).
Surface Sampling Microbial Action Levels 2022 - ANSWERSO-5 is > 3, ISO-7 is > 5,
ISO-8 or worse is > 50 (CFU /plate).
Required garbing order USP 797 2022 - ANSWERThe required garb, manner of
storage, and order of garbing must be determined by the facility and documented in the
facility's SOPs.
Component requirements for API selection (4 listed USP 797 2022)? - ANSWERWhen
APIs are used:
• MUST comply with USP-NF monograph, if one exists
• MUST have a COA that includes the specifications (e.g., compendial requirements for
quality) and that test
results for the component show that the API meets expected quality.
• In US, MUST be manufactured by an FDA-registered facility
• Outside United States, MUST comply with laws/regulations jurisdiction.
Requirements for all components OTHER THAN API selection (4 listed USP 797
2022)? - ANSWERMUST comply with USP-NF monograph, if one exists
