Pharmaceutical exam 2 2025 with
correct answers
FMEA - correct answer Failure Mode and Effects Analysis g g g g g g g g
FDA - correct answer Food and Drug Administration
g g g g g g g
EUA - correct answer Emergency Use Authorization - When the FDA authorizes an
g g g g g g g g g g g g g
unapproved medical product or unapproved uses of approved medical products to be used in
g g g g g g g g g g g g g g
an emergency to diagnose,treat or prevent serious or life-threatening diseases
g g g g g g g g g
URS - correct answer User Requirement Specification - Describes the business needs for
g g g g g g g g g g g g g
what users require from the system
g g g g g
FAT - correct answer Factory Acceptance Test - A test that runs on the equipment or
g g g g g g g g g g g g g g g g
components before it is delivered to its intended destination. g g g g g g g g
SAT - correct answer Site Acceptance Test - A test that determines the functionality of the
g g g g g g g g g g g g g g g g
equipment at the user site before installation. g g g g g g
QBD - correct answer Quality by Design - Belief that quality should be designed into a product,
g g g g g g g g g g g g g g g g g
and that most quality crises and problems relate to the way in which a product was designed in
g g g g g g g g g g g g g g g g g g
the first place.
g g
CQA - correct answer Critical Quality Attributes - Chemical, physical, biological and
g g g g g g g g g g g g
microbiological attributes that can be defined, measured, and continually monitored to g g g g g g g g g g g
ensure final product outputs remain within acceptable quality limits
g g g g g g g g
,OFCA - correct answer Oil-Free Compressed Air - Oil-free compressed air is crucial in
g g g g g g g g g g g g g g
powering the following pharmaceutical applications: g g g g
Capsule, Caplet, and Tablet Manufacturing. From mixing, hardening, and granulation to g g g g g g g g g g g
drying, pressing, coating, and packaging - compressed air comes into contact with medicine
g g g g g g g g g g g g g
at virtually every step in the manufacturing process.
g g g g g g g
Fermentation. Fermenters are aerated by sterile air. If that sterile air is contaminated, the end g g g g g g g g g g g g g g g
product is contaminated. g g
Bottling, Canning, and Packaging. Medicine can be packaged in a variety of ways, including
g g g g g g g g g g g g g g
blister packs, medicine bottles, lightweight plastic containers, and cartons. Depending on the
g g g g g g g g g g g g
product, compressed air is utilized to clean and remove moisture from these packages. g g g g g g g g g g g g g
(Please note: industrial vacuum pumps are also essential to the packaging process.)
g g g g g g g g g g g
Instrumentation Air. The tools that are used throughout the manufacturing process are fueled g g g g g g g g g g g g g
by compressed air! Because air from the tools comes into contact with the product, it must be
g g g g g g g g g g g g g g g g g
pure and oil-free. g g
Drying. Medicines are dried in order to remove any type of solvents or water from the product.
g g g g g g g g g g g g g g g g g
This process is typically completed with vacuum pumps, which assist in evaporating liquids
g g g g g g g g g g g g g
from the solids. g g
Wastewater Treatment. Water is used at various stages in the applications, and this water g g g g g g g g g g g g g g
must be treated before (and after!) use to prevent contamination. Blowers are a top choice for
g g g g g g g g g g g g g g g g
treating wastewater. g
Specification - correct answer On specifications, make sure all details are exact and focus on g g g g g g g g g g g g g g g
physical characteristics, changes could affect integrity of the product g g g g g g g g
HVAC - correct answer Heating, Ventilation and Air Conditioning
g g g g g g g g
EMA - correct answer European Medicines Agency
g g g g g g
PW - correct answer Purified Water
g g g g g
CPP - correct answer Critical Process Parameters
g g g g g g
CV - correct answer Cleaning Validation - The methodology used to assure that a cleaning
g g g g g g g g g g g g g g g
process removes chemical and microbial residues of the active, inactive or detergent
g g g g g g g g g g g g
ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in g g g g g g g g g g g g g g g
the cleaning process and the microbial attributes.
g g g g g g
RA - correct answer Risk Assessment or Regulatory Affairs
g g g g g g g g
CDER - correct answer Center for Drug Evaluation and Research
g g g g g g g g g
CBER - correct answer Center for Biologics Evaluation and Research
g g g g g g g g g
GLP - correct answer Good Lab Practices
g g g g g g
,CPSC - correct answer Consumer Product Safety Commission
g g g g g g g
SAUE - correct answer senior adult use effectiveness - the percentage of adults who both
g g g g g g g g g g g g g g g
opened the package in the first (5-minute) test period and opened and (if appropriate)
g g g g g g g g g g g g g g
properly resecured the package in the 1-minute test period g g g g g g g g
USP - correct answer United States Pharmacopeia
g g g g g g
RLD - correct answer Registered Listed Drug
g g g g g g
TE - correct answer Therapeutic Equivalent
g g g g g
NDA - correct answer New Drug Application
g g g g g g
SNDA - correct answer Supplemental New Drug Application
g g g g g g g
ANDA - correct answer Abbreviated New Drug Application - for generic drugs
g g g g g g g g g g g
483 - correct answer written warning from FDA
g g g g g g g
Current good manufacturing practice (cGMP) requirements for the control of drug product
g g g g g g g g g g g g
containers and closures are included in 21 CFR Parts 210 and 211 (True or False)? - correct g g g g g g g g g g g g g g g g g
answer True g
The cGMP regulations for drugs contain the minimum requirements for the methods,
g g g g g g g g g g g g
facilities, and controls used in manufacturing, processing, and packing of a drug product
g g g g g g g g g g g g g
(True or False)? - correct answer True
g g g g g g
What is the age range of Child Resistant and Senior Adult Use Effectiveness testing per
g g g g g g g g g g g g g g
(CFR for CR 16 CFR 1700.20)? - correct answer Children - 30% 42-44 Months 40% 45-48
g g g g g g g g g g g g g g g g
Months 30% 49-51 Months g g g
Senior Adult - 25% 50-54 Years, 25% 55-59 Years, 50% 60-70 Years
g g g g g g g g g g g
What is TRP per 21 CFR 211.132? - correct answer Tamper Resistant Packaging
g g g g g g g g g g g g
Serialization - correct answer each product is given a unique product identifier including g g g g g g g g g g g g g
national drug code, serial number, lot number, and expiration date g g g g g g g g g
Aggregation - correct answer a2D matrix the lists the serialization of its contents for example g g g g g g g g g g g g g g g
on the side of a case a data matrix exists within a scannable code that
g g g g g g g g g g g g g g
Gang Printing - correct answer multiple products on same press sheet
g g g g g g g g g g
Debarment - correct answer prohibition on doing business with government g g g g g g g g g
Overt - correct answer Obvious tamper evident seal
g g g g g g g
, Covert - correct answer not obvious like an ink that can only be seen in UV light
g g g g g g g g g g g g g g g g
Recall - correct answer A drug recall is the most effective way to protect the public from a
g g g g g g g g g g g g g g g g g g
defective or potentially harmful product. A recall is a voluntary action taken by a company atg g g g g g g g g g g g g g g g
any time to remove a defective drug product from the market.
g g g g g g g g g g
EU vs US - correct answer Bottles are common in the US and Blisters are common in the EU.
g g g g g g g g g g g g g g g g g g g
The EU also favors one size packages for products where in the US you could buy different
g g g g g g g g g g g g g g g g g
sizes.
Aclar - correct answer Aclar if applied thickly can compare to foil blister and act almost like
g g g g g g g g g g g g g g g g g
glass. The thinker the layer the less pinholing too.
g g g g g g g g
IDFK - correct answer The stomach isn't as effective as administering a drug like an injection.
g g g g g g g g g g g g g g g g
Oral tablets are not really considered sterile even though they are clean.
g g g g g g g g g g g
211.132 - correct answer Tamper-evident packaging requirements for over-the-counter
g g g g g g g g g
(OTC) human drug products g g g
ACLAR - correct answer PCTFE laminate super high barrier solution g g g g g g g g g
16 CFR 1700 - correct answer Poison Prevention
g g g g g g g
CFR 211 - correct answer cGMP for finished pharmaceuticals dance to professional
g g g g g g g g g g g g
behaviour of pharmacists, provides interpretation of laws governing pharmacy, gives legal g g g g g g g g g g g
category of drugs and medicines g g g g
OTC directory - correct answer published by Proprietary Association of Great Britain (PAGB),
g g g g g g g g g g g g g
the UK trade association for manufacturers OTC medicines and supplements, Gives details
g g g g g g g g g g g g
of OTC meds, API's and dosage instructions with info on adverse reactions and drug
g g g g g g g g g g g g g g
interactions
products are arranged into therapeutic categories according to their indications, useful for
g g g g g g g g g g g g
finding info on GSL (general sales list) or Pharmacy (p) meds, where info is not in BNF.
g g g g g g g g g g g g g g g g
contraindicated - correct answer not recommended under these circumstances g g g g g g g g
Many anti cancer drugs are dosed based on - correct answer body surface area of patient
g g g g g g g g g g g g g g g
trituration - correct answer A dilution of your required material in another solid or liquid g g g g g g g g g g g g g g
minimum weighable amount of material on sensitive balance in lab - correct answer 50mg g g g g g g g g g g g g g
you cannot accurately weigh an amount of material which is less than - correct answer 50mg
g g g g g g g g g g g g g g g
solid trituration - correct answer Both the required material and the diluent are solids.
g g g g g g g g g g g g g
correct answers
FMEA - correct answer Failure Mode and Effects Analysis g g g g g g g g
FDA - correct answer Food and Drug Administration
g g g g g g g
EUA - correct answer Emergency Use Authorization - When the FDA authorizes an
g g g g g g g g g g g g g
unapproved medical product or unapproved uses of approved medical products to be used in
g g g g g g g g g g g g g g
an emergency to diagnose,treat or prevent serious or life-threatening diseases
g g g g g g g g g
URS - correct answer User Requirement Specification - Describes the business needs for
g g g g g g g g g g g g g
what users require from the system
g g g g g
FAT - correct answer Factory Acceptance Test - A test that runs on the equipment or
g g g g g g g g g g g g g g g g
components before it is delivered to its intended destination. g g g g g g g g
SAT - correct answer Site Acceptance Test - A test that determines the functionality of the
g g g g g g g g g g g g g g g g
equipment at the user site before installation. g g g g g g
QBD - correct answer Quality by Design - Belief that quality should be designed into a product,
g g g g g g g g g g g g g g g g g
and that most quality crises and problems relate to the way in which a product was designed in
g g g g g g g g g g g g g g g g g g
the first place.
g g
CQA - correct answer Critical Quality Attributes - Chemical, physical, biological and
g g g g g g g g g g g g
microbiological attributes that can be defined, measured, and continually monitored to g g g g g g g g g g g
ensure final product outputs remain within acceptable quality limits
g g g g g g g g
,OFCA - correct answer Oil-Free Compressed Air - Oil-free compressed air is crucial in
g g g g g g g g g g g g g g
powering the following pharmaceutical applications: g g g g
Capsule, Caplet, and Tablet Manufacturing. From mixing, hardening, and granulation to g g g g g g g g g g g
drying, pressing, coating, and packaging - compressed air comes into contact with medicine
g g g g g g g g g g g g g
at virtually every step in the manufacturing process.
g g g g g g g
Fermentation. Fermenters are aerated by sterile air. If that sterile air is contaminated, the end g g g g g g g g g g g g g g g
product is contaminated. g g
Bottling, Canning, and Packaging. Medicine can be packaged in a variety of ways, including
g g g g g g g g g g g g g g
blister packs, medicine bottles, lightweight plastic containers, and cartons. Depending on the
g g g g g g g g g g g g
product, compressed air is utilized to clean and remove moisture from these packages. g g g g g g g g g g g g g
(Please note: industrial vacuum pumps are also essential to the packaging process.)
g g g g g g g g g g g
Instrumentation Air. The tools that are used throughout the manufacturing process are fueled g g g g g g g g g g g g g
by compressed air! Because air from the tools comes into contact with the product, it must be
g g g g g g g g g g g g g g g g g
pure and oil-free. g g
Drying. Medicines are dried in order to remove any type of solvents or water from the product.
g g g g g g g g g g g g g g g g g
This process is typically completed with vacuum pumps, which assist in evaporating liquids
g g g g g g g g g g g g g
from the solids. g g
Wastewater Treatment. Water is used at various stages in the applications, and this water g g g g g g g g g g g g g g
must be treated before (and after!) use to prevent contamination. Blowers are a top choice for
g g g g g g g g g g g g g g g g
treating wastewater. g
Specification - correct answer On specifications, make sure all details are exact and focus on g g g g g g g g g g g g g g g
physical characteristics, changes could affect integrity of the product g g g g g g g g
HVAC - correct answer Heating, Ventilation and Air Conditioning
g g g g g g g g
EMA - correct answer European Medicines Agency
g g g g g g
PW - correct answer Purified Water
g g g g g
CPP - correct answer Critical Process Parameters
g g g g g g
CV - correct answer Cleaning Validation - The methodology used to assure that a cleaning
g g g g g g g g g g g g g g g
process removes chemical and microbial residues of the active, inactive or detergent
g g g g g g g g g g g g
ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in g g g g g g g g g g g g g g g
the cleaning process and the microbial attributes.
g g g g g g
RA - correct answer Risk Assessment or Regulatory Affairs
g g g g g g g g
CDER - correct answer Center for Drug Evaluation and Research
g g g g g g g g g
CBER - correct answer Center for Biologics Evaluation and Research
g g g g g g g g g
GLP - correct answer Good Lab Practices
g g g g g g
,CPSC - correct answer Consumer Product Safety Commission
g g g g g g g
SAUE - correct answer senior adult use effectiveness - the percentage of adults who both
g g g g g g g g g g g g g g g
opened the package in the first (5-minute) test period and opened and (if appropriate)
g g g g g g g g g g g g g g
properly resecured the package in the 1-minute test period g g g g g g g g
USP - correct answer United States Pharmacopeia
g g g g g g
RLD - correct answer Registered Listed Drug
g g g g g g
TE - correct answer Therapeutic Equivalent
g g g g g
NDA - correct answer New Drug Application
g g g g g g
SNDA - correct answer Supplemental New Drug Application
g g g g g g g
ANDA - correct answer Abbreviated New Drug Application - for generic drugs
g g g g g g g g g g g
483 - correct answer written warning from FDA
g g g g g g g
Current good manufacturing practice (cGMP) requirements for the control of drug product
g g g g g g g g g g g g
containers and closures are included in 21 CFR Parts 210 and 211 (True or False)? - correct g g g g g g g g g g g g g g g g g
answer True g
The cGMP regulations for drugs contain the minimum requirements for the methods,
g g g g g g g g g g g g
facilities, and controls used in manufacturing, processing, and packing of a drug product
g g g g g g g g g g g g g
(True or False)? - correct answer True
g g g g g g
What is the age range of Child Resistant and Senior Adult Use Effectiveness testing per
g g g g g g g g g g g g g g
(CFR for CR 16 CFR 1700.20)? - correct answer Children - 30% 42-44 Months 40% 45-48
g g g g g g g g g g g g g g g g
Months 30% 49-51 Months g g g
Senior Adult - 25% 50-54 Years, 25% 55-59 Years, 50% 60-70 Years
g g g g g g g g g g g
What is TRP per 21 CFR 211.132? - correct answer Tamper Resistant Packaging
g g g g g g g g g g g g
Serialization - correct answer each product is given a unique product identifier including g g g g g g g g g g g g g
national drug code, serial number, lot number, and expiration date g g g g g g g g g
Aggregation - correct answer a2D matrix the lists the serialization of its contents for example g g g g g g g g g g g g g g g
on the side of a case a data matrix exists within a scannable code that
g g g g g g g g g g g g g g
Gang Printing - correct answer multiple products on same press sheet
g g g g g g g g g g
Debarment - correct answer prohibition on doing business with government g g g g g g g g g
Overt - correct answer Obvious tamper evident seal
g g g g g g g
, Covert - correct answer not obvious like an ink that can only be seen in UV light
g g g g g g g g g g g g g g g g
Recall - correct answer A drug recall is the most effective way to protect the public from a
g g g g g g g g g g g g g g g g g g
defective or potentially harmful product. A recall is a voluntary action taken by a company atg g g g g g g g g g g g g g g g
any time to remove a defective drug product from the market.
g g g g g g g g g g
EU vs US - correct answer Bottles are common in the US and Blisters are common in the EU.
g g g g g g g g g g g g g g g g g g g
The EU also favors one size packages for products where in the US you could buy different
g g g g g g g g g g g g g g g g g
sizes.
Aclar - correct answer Aclar if applied thickly can compare to foil blister and act almost like
g g g g g g g g g g g g g g g g g
glass. The thinker the layer the less pinholing too.
g g g g g g g g
IDFK - correct answer The stomach isn't as effective as administering a drug like an injection.
g g g g g g g g g g g g g g g g
Oral tablets are not really considered sterile even though they are clean.
g g g g g g g g g g g
211.132 - correct answer Tamper-evident packaging requirements for over-the-counter
g g g g g g g g g
(OTC) human drug products g g g
ACLAR - correct answer PCTFE laminate super high barrier solution g g g g g g g g g
16 CFR 1700 - correct answer Poison Prevention
g g g g g g g
CFR 211 - correct answer cGMP for finished pharmaceuticals dance to professional
g g g g g g g g g g g g
behaviour of pharmacists, provides interpretation of laws governing pharmacy, gives legal g g g g g g g g g g g
category of drugs and medicines g g g g
OTC directory - correct answer published by Proprietary Association of Great Britain (PAGB),
g g g g g g g g g g g g g
the UK trade association for manufacturers OTC medicines and supplements, Gives details
g g g g g g g g g g g g
of OTC meds, API's and dosage instructions with info on adverse reactions and drug
g g g g g g g g g g g g g g
interactions
products are arranged into therapeutic categories according to their indications, useful for
g g g g g g g g g g g g
finding info on GSL (general sales list) or Pharmacy (p) meds, where info is not in BNF.
g g g g g g g g g g g g g g g g
contraindicated - correct answer not recommended under these circumstances g g g g g g g g
Many anti cancer drugs are dosed based on - correct answer body surface area of patient
g g g g g g g g g g g g g g g
trituration - correct answer A dilution of your required material in another solid or liquid g g g g g g g g g g g g g g
minimum weighable amount of material on sensitive balance in lab - correct answer 50mg g g g g g g g g g g g g g
you cannot accurately weigh an amount of material which is less than - correct answer 50mg
g g g g g g g g g g g g g g g
solid trituration - correct answer Both the required material and the diluent are solids.
g g g g g g g g g g g g g
