BTEC 3317 Quiz 10

What is not true of cGMP?

The phrase "Good Manufacturing Practices" first appeared in the Food, Drug, and Cosmetic Act of 1938, to set tolerances for toxic ingredients in drugs, such as cocaine, heroine, alcohol and morphine

cGMP requires documentation of process performance and product quality through accurate and complete written records

cGMP stands for current Good Manufacturing Practices

cGMP is required for drugs manufactured for use in pre-clinical testing

cGMP is required for drugs manufactured for use in pre-clinical testing

3 multiple choice options

cGMPs are regulations that govern the manufacture of food, drugs, biologics, and medical devices to assure the quality, identity, purity and strength (QuIPS) of the finished product consistently over the life of the product. What quality attribute of a drug product, like vitamins or antibiotics, is expressed in activity or international units (IU)?

Strength

Stability

Identity

Purity

Strength

3 multiple choice options

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.

FDA investigators

Trial sponsor

Principal investigator

Person responsible for non-compliance

Person responsible for non-compliance

3 multiple choice options

Component refers to any ingredient used in the manufacture of a drug product, including those that may no longer be detectable in the marketed drug product.

TRUE

FALSE

TRUE

1 multiple choice option

In drug manufacturing, what does not apply to the batch number?

The batch number consists of a combination of letter(s) and numbers

The batch number is the total number of units produced in a single manufacturing run

The batch number facilitates recall of a batch of drugs found with quality issues

The batch number is useful in knowing the history of the manufacture, packing, holding and distribution of a drug product

The batch number is the total number of units produced in a single manufacturing run

3 multiple choice options

ICHQ7A are guidances observed for the manufacture of ________________, while FDAs cGMPs in CFR21 part 211 are regulations that mainly cover the manufacture of _______________.

Active Pharmaceutical Ingredients:Finished drug pharmaceuticals

Biologics: Pharmaceutical drugs

Generic drugs: Biologics

Finished drug products: Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredients:Finished drug pharmaceuticals

3 multiple choice options

What is not true of phase III drug manufacturing activities?

During phase III is usually when a company puts drug products in a stability program to determine how product quality deteriorates or is preserved with time

During phase III is when lead optimization is finalized

During Phase III, the company prepares extensively for FDA's pre-approval inspection

During phase III, company demonstrates that they are able to manufacture 3 lots of drug products that meet quality specifications

During phase III is when lead optimization is finalized

3 multiple choice options

cGMP requires the establishment of a quality system and the designation of an independent quality unit to oversee the quality system. The quality control unit is not responsible for the approval and release of:

the company's quarterly financial reports

raw materials and in-process materials

components, containers, and closures

packaging and labeling materials

the company's quarterly financial reports

3 multiple choice options

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?

Prevent the inhalation of microbial aerosols

Protect the workers from dust

Prevent contamination of the drug

Protect the workers from toxic fumes

Prevent contamination of the drug

3 multiple choice options

Which of the following CFR21 part 211 regulations is not found under subpart B on organization and personnel?

Personnel should wear apparel appropriate to protect product from contamination

Personnel should not eat while working on the manufacturing floor

There must be controlled personnel access to certain limited-access areas

Personnel must have education, cGMP training, and experience to perform the assigned functions

Personnel should not eat while working on the manufacturing floor

3 multiple choice options

What is not part of cGMP regulations concerning buildings and facilities?

The washing and toilet facilities should be very far from the manufacturing suites

Cleaning should be performed according to procedures and as scheduled

There should be good product flow starting from the raw material receiving, to manufacturing, and to distribution of drug products.

The facility should be of sufficient size to allow separation of different manufacturing activities

The washing and toilet facilities should be very far from the manufacturing suites

3 multiple choice options

For a New Drug Application (NDA) filing, the FDA requires at least _________ lots, or batches, of the drug product to be manufactured with consistent quality and evaluated in a stability program.

3 lots

2 lots

5 lots

1 lot

3 lots

3 multiple choice options

What is not a cGMP requirement for equipment?

Equipment should be cleaned as scheduled according to pre-written procedures

The effect of a replacement part on the quality of the product should be evaluated before implementation

Equipment should be highly reactive with the product

Only food-grade lubricants or oils should be used for maintaining equipment

Equipment should be highly reactive with the product

3 multiple choice options

Under equipment cGMP regulations, what is an example of how computer systems would be considered as deficient in controls that are needed to assure consistent operation?

All laboratory analysts share the same password for the computer which runs the AKTA which is used for protein separation

Requalification of equipment was performed because a new software was installed

All files and data are backed up in case of system malfunction

Operations are performed by one person and double-checked by another

All laboratory analysts share the same password for the computer which runs the AKTA which is used for protein separation

3 multiple choice options

There are four phases in biotherapeutic protein production described in the Roche video. Which is not one of the four?

The recombinant DNA construct is transformed into E. coli

Fermentation of cells in bioreactors at manufacturing scale

Cells are separated from the nutrient solution by centrifugation and filtration

Cultivation starts from frozen animal cells

The recombinant DNA construct is transformed into E. coli

3 multiple choice options