Examen

BCSCP Prep . QUESTIONS WITH CORRECT AND VERIFIED ANSWERS. GRADED A+.

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03-09-2025

Escrito en

2020/2021

BCSCP Prep . QUESTIONS WITH CORRECT AND VERIFIED ANSWERS. GRADED A+. The intent of 797 chapter to prevent harm, including death from what five risks? 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)? 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 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? 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? 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) 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.

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BCSCP Prep 2025-2026.

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BCSCP Prep 2025-2026.

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Institución: BCSCP Prep 2025-2026.
Grado: BCSCP Prep 2025-2026.

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Subido en: 3 de septiembre de 2025
Número de páginas: 99
Escrito en: 2020/2021
Tipo: Examen
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bcscp prep questions with answers

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