Exam (elaborations)
BTC 195 Exam 1 Questions & Answers 2024/2025
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BTC 195 Exam 1 Questions & Answers 2024/2025
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BTC 195 Exam 1 Questions & Answers2024/2025
The three key elements are: controls, competence and personnel. Physical product is examined visually.
Provides lists and descriptions of unacceptable production defects - ANSWERSquality control
toxicology - ANSWERSEstablish potential adverse effects of drug on humans using various animals as
required by law - FDA
batch records - ANSWERSEstablish what is to be done and has it been done. This is a permanent record
associated with each drug through production.
supply chain management - ANSWERSInvolves the movement and storage of raw materials, of work-in-
process inventory, and of finished goods from point of origin to point of consumption
SOPs - ANSWERSDescribe how to conduct task. Contains worksheets that will be attached to batch
record or lab record
process development - ANSWERSArea of biomanufacturing where unit operations are connected by
production streams in flow diagrams
Clinical - ANSWERSPhase testing of drug in humans. Establish safety and efficacy
sterilize in place (SIP) - ANSWERSUsually done with clean steam to eliminate contaminating organisms
from all surfaces contacted by media and cell culture
clean in place (CIP) - ANSWERSA treatment usually done with strong base followed by weak phosphoric
acid and a final rinse with water for injection
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