BCSCP Exam Questions and Answers | 100% Pass!!
USP Supplements -Answer-First published in Feb, official Aug 1. Second published in
June, official Dec 1.
Public Health Service Act -Answer-Biologics License Application (BLA)
351(k) pathway for biosimilars
Enforcement of USP Standards -Answer-Res...
BCSCP Exam Questions and Answers | 100% Pass!! USP Supplements -Answer -First published in Feb, official Aug 1. Second published in June, official Dec 1. Public Health Service Act -Answer -Biologics License Application (BLA) 351(k) pathway for biosimilars Enforcement of USP Standards -Answer -Responsibility of FDA and other govt authorities. USP has no role in enforcement "About" -Answer -Indicates a quantity within 10% USP 795 bulk product expiration -Answer -Compounder shall label with date of receipt and assign a conservative expiration date not to exceed 3 yrs 795 BUD Nonaqueous formulations -Answer -Not later than the time remaining until the earliest expiration day of any API or 6 months 795 BUD Water Containing Oral Formulation -Answer -Not later than 14 days when stored at controlled cold temp 795 BUD Water Containing Topical & Mucosal Liquids -Answer -Not later than 30 days Compounding Documentation -Answer -Records retained for the same period of time required for any prescription under state law May be a copy of the prescription Should include Master Formulation Record and Compounding Record ISO Class of Particulates in Room Air -Answer -Limits are in particulates of 5 um and larger per cubic meter ISO 5 (class 100) 3,520 ISO 7 (class 10,000) 352,000 ISO 8 (class 100,000) 3,520,000 Low Risk CSP -Answer -Not more than 3 packages & not more than 2 entries 48 hr at room temp (20 -25) 14 days at cold temp (2 -8) 45 days solid frozen state ( -25 to -10) Low Risk 12 hr BUD -Answer -Non hazardous & radio pharmaceuticals Segregated compounding area -Answer -ISO 5 PEC No unsealed windows or doors that connect to outdoors or high traffic Not adjacent to construction, warehouses, or food prep Media -Fill Testing -Answer -Annually Simulates most challenging or stressful conditions Completed without interruption Soybean Casein Digest Medium (trypticase soy broth or tyrpticase soy agar) Incubated 20 -25 or 30 -35 for min 14 days Medium Risk CSP -Answer -Multiple individual or small doses of sterile products combined, more complex manipulation, with medium risk storage (30 hours at room temp, 9 days refrigerated, 45 days frozen) Ex: TPN, reservoirs High Risk CSP -Answer -Non sterile ingredients Exposed to air quality worse than ISO 5 for more than 1 hour Improperly garbed personnel Nonsterilized water containing CSP stored >6 hrs before sterilizes BUD 24 hr/3 days/45 days Sterility tests not required unless batches of >25 units Dry Heat Sterilization -Answer -Done as a batch in an oven designed for sterilization Heat filtered air evenly distributed throughout chamber by blower Requires higher temp and longer exposure than steam sterilization Use only for materials that cannot he steam sterilized Verified by BI Bacillus subtilis and temp sensing devices Dry heat may be preformed at lower temp than may be effective for depyrogenation Depyrogenation by dry heat -Answer -Used to render glassware it containers free of pyrogens & viable microbes 30 minutes at 250 Verified using endotoxin challenge vials (ECVs) to verify cycle capable of achieving 3 -
log reduction in endotoxin High Risk CSP Prep -Answer -All no sterile devices rinsed with sterile, pyrogens free water then drained or dried immediately prior to high risk compounding Prefiltered by passing thru filter not larger than 1.2 um proceeding or during filling to remove particulates Sterilization with 0.2 um filter within PEC High Risk Conditions -Answer -Nonsterile bulk drugs that will be terminally sterilized Exposing sterile ingredients to worse than ISO 5 air for more than 1 hour Mixing sterile ingredients in nonsterile devices Assuming without evidence that bulk ingredients contain at least 95% of active chemical & have not been contaminated or adulterated between uses
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