Btech Exam 10/11 Questions & Answers
2024/2025
Q1
Which of the following CFR21 part 211 regulations is found under subpart B on organization and
personnel? - ANSWERS- Personnel should wear apparel appropriate to protect product from
contamination
- There must be controlled access only to limited-access areas
- Personnel must have education, cGMP training, and experience to perform the assigned functions
- Personnel must observe good sanitation and health habits
NOT
Personnel must have appropriate healing, ventilations, and air-conditioning (HVAC) to be comfortable
while working
ICHQ7A contain guidances observed for the manufacture of _______ while FDA's cGMPs in CFR21 part
211 are regulations that mainly cover the manufacture of _______ - ANSWERSAPI : Finished Drug
Pharmaceuticals
adherence to cGMPs are usually not required for drugs manufacture for phase 1 use and after the drug
has recieved marketing approval, but for all drugs manufactured for use in phase 2 and 3 clinical trials -
ANSWERSFALSE
cGMP apply throughout the entire process
cGMPs are regulations that govern the manufacture of food, drugs, biologics, and medical devices to
assure the quality, indentity, purity, and strength of the finished product ________ over the life of the
product - ANSWERSConsistently
Under the Kefauver-Harris amendments of the Federal Food Drugs and Cosmetic Act (FFDCA), if the
methods used in , or the facilities or controls used for, the manufacture, processing, packaging, or
holding, of the drug product do not conform to cGMP, the adulterated drug as well as the
, _______________________shall be subject to regulatory action. - ANSWERSPerson responsible for non-
compliance
The percentage of theoretical yield is the ratio of the __________ yield to ___________ yield stated as a
percentage. - ANSWERSActual : Theoretical
_______ means a sample that consists of a number of units that are drawn based on statistically sound
criteria and intended to assure that the sample accurately portrays the material being sampled -
ANSWERSRepresenatitive
What is a part of cGMP regulations concerning buildings and facilities - ANSWERS- There should be a site
map showing good product flow designed to prevent mix-ups and contamination
- Building sanitation must be performed according to schedule
- There should be adequate lighting , ventilation and plumbing
- There should be adequate sewage, refuse, washing and toilet facilities
NOT
Mouse and roach traps should not be found in the cGMP facility
The Drug Enforcement Administration (DEA) regulatory mandate comes mostly from which law? -
ANSWERSControlled Substance Act
Under CFR 21 part 210, current Good Manifacturing Practice regulations apply only to pharmaceutical
types of drugs examples of which are asprin, ibuprofen, and acetaminophen - ANSWERSFalse
by pharmaceutical drugs, biologics, cell, tissue
From the Amgen video, what is the greatest source of product contamination in a sterile drug
manufacturing facility? - ANSWERSPersonnel
cGMP requires _________ of process performance and product quality through written records -
ANSWERSDocumentation
2024/2025
Q1
Which of the following CFR21 part 211 regulations is found under subpart B on organization and
personnel? - ANSWERS- Personnel should wear apparel appropriate to protect product from
contamination
- There must be controlled access only to limited-access areas
- Personnel must have education, cGMP training, and experience to perform the assigned functions
- Personnel must observe good sanitation and health habits
NOT
Personnel must have appropriate healing, ventilations, and air-conditioning (HVAC) to be comfortable
while working
ICHQ7A contain guidances observed for the manufacture of _______ while FDA's cGMPs in CFR21 part
211 are regulations that mainly cover the manufacture of _______ - ANSWERSAPI : Finished Drug
Pharmaceuticals
adherence to cGMPs are usually not required for drugs manufacture for phase 1 use and after the drug
has recieved marketing approval, but for all drugs manufactured for use in phase 2 and 3 clinical trials -
ANSWERSFALSE
cGMP apply throughout the entire process
cGMPs are regulations that govern the manufacture of food, drugs, biologics, and medical devices to
assure the quality, indentity, purity, and strength of the finished product ________ over the life of the
product - ANSWERSConsistently
Under the Kefauver-Harris amendments of the Federal Food Drugs and Cosmetic Act (FFDCA), if the
methods used in , or the facilities or controls used for, the manufacture, processing, packaging, or
holding, of the drug product do not conform to cGMP, the adulterated drug as well as the
, _______________________shall be subject to regulatory action. - ANSWERSPerson responsible for non-
compliance
The percentage of theoretical yield is the ratio of the __________ yield to ___________ yield stated as a
percentage. - ANSWERSActual : Theoretical
_______ means a sample that consists of a number of units that are drawn based on statistically sound
criteria and intended to assure that the sample accurately portrays the material being sampled -
ANSWERSRepresenatitive
What is a part of cGMP regulations concerning buildings and facilities - ANSWERS- There should be a site
map showing good product flow designed to prevent mix-ups and contamination
- Building sanitation must be performed according to schedule
- There should be adequate lighting , ventilation and plumbing
- There should be adequate sewage, refuse, washing and toilet facilities
NOT
Mouse and roach traps should not be found in the cGMP facility
The Drug Enforcement Administration (DEA) regulatory mandate comes mostly from which law? -
ANSWERSControlled Substance Act
Under CFR 21 part 210, current Good Manifacturing Practice regulations apply only to pharmaceutical
types of drugs examples of which are asprin, ibuprofen, and acetaminophen - ANSWERSFalse
by pharmaceutical drugs, biologics, cell, tissue
From the Amgen video, what is the greatest source of product contamination in a sterile drug
manufacturing facility? - ANSWERSPersonnel
cGMP requires _________ of process performance and product quality through written records -
ANSWERSDocumentation
