Exam 2: DEA, cGMP, ICH - The Q7A Flashcards
What is true of cGMP?
A) cGMPs for drugs are found in CFR40 part 211
B) cGMP is not required for the manufacture of all marketed drugs
C) cGMP is required for all drugs manufactured for use in Phase I trials
D) cGMP regulations are not required for the manufacture of drugs which are for use in pre-clinical testing
E) cGMP stands for correct Good Manufacturing Practices
D) cGMP regulations are not required for the manufacture of drugs which are for use in pre-clinical testing
What are actions taken to address products which failed to meet passing criteria?
A) Corrective and preventative actions
B) Deviation avoidance actions
C) Failure assessment actions
D) Rejection and recall actions
E) Criteria avoidance actions
A) Corrective and preventative actions
cGMPs are regulations that govern the manufacture of food, drugs, biologics, and medical devices to assure the _____________________ (QuIPS) of the finished product consistently over the life of the product.
A) quality, identity, patent, and strength
B) quantitation, identity, purity, and strength
C) quality, isolation, purity, and strength
D) quality, identity, purity, and strength
E) quality, identity, purity, and solubility
D) quality, identity, purity, and strength
Which quality attribute of a drug product is represented by the concentration of the active ingredient expressed in mg per ml, or mg per tablet or capsule?
A) Dissolution rate
B) Identity
C) Purity
D) Strength
E) Stability
D) Strength
What is not a possible source of active pharmaceutical ingredient (API) for use as raw material for drug manufacturing?
A) The active ingredient can be extracted from the final drug product
B) The active ingredient can be a recombinant protein produced by cells
C) The active ingredient can be prepared by chemical synthesis
D) The active ingredient can be prepared by natural product isolation
E) The active ingredient can be prepared from a fungus known to produce an antibiotic
A) The active ingredient can be extracted from the final drug product
In drug manufacturing, the batch number is not:
A) The batch number is the number of units manufactured on a certain date
B) The batch number facilitates recall of a batch of drugs found with quality issues
C) The batch number consists of a combination of letter(s) and numbers
D) The batch number is useful in knowing the history of the manufacture, packing, holding and distribution of a drug product
E) The batch number is a type of information that is found and required to be present in drug labels
A) The batch number is the number of units manufactured on a certain date
ICHQ7A are guidances observed for the manufacture of ________________, while FDAs cGMPs in CFR21 part 211 are regulations that mainly cover the manufacture of _______________.
A) Biologics: Pharmaceutical drugs
B) Finished drug products: Active Pharmaceutical Ingredients
C) Raw materials:In-process materials
D) Active Pharmaceutical Ingredients:Finished drug pharmaceuticals
E) Generic drugs: Biologics
D) Active Pharmaceutical Ingredients:Finished drug pharmaceuticals
What is not true of phase III drug manufacturing activities?
A) During phase III is when pilot scale manufacturing process is finalized
B) During Phase III, the company may start manufacturing supply for anticipated commercial launch
C) During phase III, company needs to demonstrate comparability of quality of phIII materials with that of the phII materials
D) During phase III, company demonstrates that they are able to manufacture 3 lots of drug products that meet quality specifications
A) During phase III is when pilot scale manufacturing process is finalized
The responsibilities of the quality unit are divided into two. The quality _____________ unit develops and performs the laboratory procedures for testing of materials or drug products, while the quality _____________ unit makes sure that documented evidence is available that quality related activities, were followed by the former group.
A) Control:regulatory
B) Regulatory:assurance
C) Control:assurance
D) Assurance: control
E) Check:assurance
C) Control:assurance
From the Amgen video, what is the main reason as to why personnel wear full body gowns or suits before entering a sterile drug production suite?
A) Prevent the inhalation of microbial aerosols
B) Prevent contamination of the drug
C) Protect the workers from dust
D) Protect the workers from toxic fumes
E) Prevent infection of manufacturers by viruses
B) Prevent contamination of the drug
Which of the following CFR21 part 211 regulations is not found under subpart B on organization and personnel?
A) Personnel should wear apparel appropriate to protect product from contamination
B) Personnel must observe good sanitation and health habits
C) There must be controlled personnel access to certain limited-access areas
D) Personnel must be provided with air purified by High Efficiency Particulate Air (HEPA) filters to provide them with clean air to breathe
E) Personnel must have education, cGMP training, and experience to perform the assigned functions
D) Personnel must be provided with air purified by High Efficiency Particulate Air (HEPA) filters to provide them with clean air to breathe
What would not be one reason as to why cGMP regulations on building and facilities require that inspection areas have adequate lighting?
A) to be able to ascertain the color attribute of the dosage form
B) to be able to verify the correct batch number on drug labels
C) to check for the presence of contaminants like glass pieces in the drug product.
D) To be able to examine conformance of drug product appearance to specifications
E) to be able to pick up tablets that have fallen on the manufacturing floor
E) to be able to pick up tablets that have fallen on the manufacturing floor
What is not part of cGMP regulations concerning buildings and facilities?
A) Washing areas should be readily accessible to personnel, yet separated from the manufacturing area
B) There should be a site map showing good product flow designed to prevent mix-ups and contamination
C) There should be good product flow starting from the raw material receiving, to manufacturing, and to distribution of drug products.
D) The washing and toilet facilities should be as far away as possible from the manufacturing suites
E) Mechanisms to control mice and insects should be in place
D) The washing and toilet facilities should be as far away as possible from the manufacturing suites
What is not a cGMP requirement for equipment?
A) All manufacturing personnel should know every technicians’ password in case of sickness
B) equipment should be cleaned and maintained as scheduled according to pre-written procedures
C) only food-grade lubricants or oils should be used for maintaining equipment
D) Data entered into computer systems by one analyst should be counterchecked by a second analyst
E) Equipment in contact with the product should be non-reactive, like stainless steel
A) All manufacturing personnel should know every technicians’ password in case of sickness
There are four phases in biotherapeutic protein production described in the Roche video. Which is not one of the four?
A) The cloning vector is digested with a restriction enzyme
B) Purification of the biotherapeutic protein by chromatography
C) Frozen animal cells are transferred and cultivated in nutrient solution
D) The purified product is filled into cryovessels for formulation into the finished drug
E) Animal cells are cultured in large, stainless steel bioreactors
A) The cloning vector is digested with a restriction enzyme
