CGMP ASSESSMENT TEST
QUESTIONS AND
CORRECT ANSWERS
GRADED A+ 2025-2026
Current good compounding practices (GCP) come from where? - ANS-U.S.
Pharmacopeia-National Formulary
Food and Drug Modernization Act of 1997
National Association of Boards of Pharmacy
cGMP - ANS-current good manufacturing practice
Standards for cGMP - ANS-- Established by the FDA
- Ensure that minimum standards are met for drug product quality
- Promulgated in 1963 under Kefauver-Harris Drug Amendments
- Code of Federal Regulations
US Federal Food, Drug & Cosmetic Act - ANS-- A consumer protection law
New Drug Amendment of 1962 - ANS-- A drug or device shall be deemed to be
adulterated (a) (2) (b) if it is a drug and the methods used in, or the facilities or
controls used for its manufacture, processing, packaging or holding do not conform to
or are not operated or administered in conformity with cGMP to assure that such drugs
meet the requirement of this Act as to safety and has the identity and strength, and
, meet the quality and purity characteristics, which it purports or is represented to
possess
- FDA promulgated complete regulations translating the statutory directive into
detailed and instructive requirements.
Good Manufacturing Practice (GMP) is defined as - ANS-"The part of Quality Assurance
which ensures that products are consistently produced and controlled in accordance
with the quality standards appropriate to their intended use"
"Food & Drug Administration's regulations that describe the methods, equipment and
facilities and controls required for producing human and veterinary products"
The expectations from GMPs are - ANS-dynamic and represents minimum
requirements
Main objectives of GMP - ANS-To prevent distribution and use of unacceptable drugs,
cosmetics and medical devices by man or for animals
To prevent inadvertent release of raw materials, additives and components into the
manufacturing system
According to Jones Bassen in FDA Bulletin (1968): - ANS-FDA expects that responsible
firms will voluntarily correct conditions observed during establishments inspection
which do not conform with cGMP
FDA Mandate - ANS-FDA is more than an enforcement Mechanism
FDA & industry must be alert to recognize health hazards & promptly device measures
& practices to cope with them
FDA is poised to help industry improve its quality controls to raise the quality
assurance level of its products
QUESTIONS AND
CORRECT ANSWERS
GRADED A+ 2025-2026
Current good compounding practices (GCP) come from where? - ANS-U.S.
Pharmacopeia-National Formulary
Food and Drug Modernization Act of 1997
National Association of Boards of Pharmacy
cGMP - ANS-current good manufacturing practice
Standards for cGMP - ANS-- Established by the FDA
- Ensure that minimum standards are met for drug product quality
- Promulgated in 1963 under Kefauver-Harris Drug Amendments
- Code of Federal Regulations
US Federal Food, Drug & Cosmetic Act - ANS-- A consumer protection law
New Drug Amendment of 1962 - ANS-- A drug or device shall be deemed to be
adulterated (a) (2) (b) if it is a drug and the methods used in, or the facilities or
controls used for its manufacture, processing, packaging or holding do not conform to
or are not operated or administered in conformity with cGMP to assure that such drugs
meet the requirement of this Act as to safety and has the identity and strength, and
, meet the quality and purity characteristics, which it purports or is represented to
possess
- FDA promulgated complete regulations translating the statutory directive into
detailed and instructive requirements.
Good Manufacturing Practice (GMP) is defined as - ANS-"The part of Quality Assurance
which ensures that products are consistently produced and controlled in accordance
with the quality standards appropriate to their intended use"
"Food & Drug Administration's regulations that describe the methods, equipment and
facilities and controls required for producing human and veterinary products"
The expectations from GMPs are - ANS-dynamic and represents minimum
requirements
Main objectives of GMP - ANS-To prevent distribution and use of unacceptable drugs,
cosmetics and medical devices by man or for animals
To prevent inadvertent release of raw materials, additives and components into the
manufacturing system
According to Jones Bassen in FDA Bulletin (1968): - ANS-FDA expects that responsible
firms will voluntarily correct conditions observed during establishments inspection
which do not conform with cGMP
FDA Mandate - ANS-FDA is more than an enforcement Mechanism
FDA & industry must be alert to recognize health hazards & promptly device measures
& practices to cope with them
FDA is poised to help industry improve its quality controls to raise the quality
assurance level of its products
