GLP and GMP Principles Review Test 2023

LP and GMP Principles Review Test 2023 What does GLP stand for? - ANS-good laboratory practices What does GMP stand for? - ANS-good manufacturing practices When were biologics manufactured on a large scale? - ANS-1980 What does CDER stand for? - ANS-Center for Drug Evaluation and Research What does the CDER regulate? - ANS-small molecules and drugs What does CBER stand for? - ANS-Center for Biologics Evaluation and Research What does CBER regulate? - ANS-biologics Which agency regulates small molecules? - ANS-CDER Which agency regulates biologics? - ANS-CBER What organization is CDER and CBER a part of? - ANS-FDA What does FDA stand for? - ANS-Food and Drug Administration What is an example of a small molecule drug? - ANS-aspirin What is an example of a biologic? - ANS-insulin How are small molecules or drugs made? - ANS-chemical synthesis by combining chemical ingredients in ordered process Can components of drugs be tested or characterized fully? - ANS-yes (because of unique atomic fingerprint and physical properties) How are biologics made? - ANS-made in living systems What kind of technology does biologics employ? - ANS-recombinant DNA technology Can components of biologics be tested or characterized fully? - ANS-no (because they are no atomic fingerprints to reference) What does it meant by "the product is the process" in terms of biologics? - ANS-because biologics can't be fully characterized in lab, manufacturers must make sure product is manufactured with the same quality and purity all the time (consistency) How does the manufacturing process of a biologic remain consistent? - Continues...