Quiz 10 BTEC 3317

What is not true of cGMP?

 

cGMP stands for current Good Manufacturing Practices

 

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

 

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

 

cGMP is required for drugs manufactured for marketing

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

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

 

Dissolution rate

 

Identity

 

Purity

Strength

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.

 

Person responsible for non-compliance

 

Principal investigator

 

Trial sponsor

 

Non-consenting trial participant

 

FDA investigators

Person responsible for non-compliance

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

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 useful in knowing the history of the manufacture, packing, holding and distribution of a drug product

 

The batch number is a type of information that is found and required to be present in drug labels

 

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 the total number of units produced in a single manufacturing run

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

 

Active Pharmaceutical Ingredients:Finished drug pharmaceuticals

 

Biologics: Pharmaceutical drugs

 

Finished drug products: Active Pharmaceutical Ingredients

 

Raw materials:In-process materials

 

Generic drugs: Biologics

Active Pharmaceutical Ingredients:Finished drug pharmaceuticals

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

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:

 

final drug product

 

the company's quarterly financial reports

 

components, containers, and closures

 

raw materials and in-process materials

 

packaging and labeling materials

the company's quarterly financial reports

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 toxic fumes

 

Prevent infection of manufacturers by viruses

 

Prevent contamination of the drug

 

Protect the workers from dust

Prevent contamination of the drug

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

 

Personnel must observe good sanitation and health habits

 

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

 

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

 

Personnel should not eat while working on the manufacturing floor

 

Personnel should wear apparel appropriate to protect product from contamination

Personnel should not eat while working on the manufacturing floor

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

 

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

 

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

 

Facility should have divisions for all the different processes to avoid mix-ups

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

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.

 

1 lot

 

2 lots

 

5 lots

 

10 lots

 

3 lots

3 lots

What is not a cGMP requirement for equipment?

 

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 design should meet the quality requirements of the product

 

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

Equipment should be highly reactive with the product

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?

 

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

 

Requalification of equipment was performed because a new software was installed

 

All authorized users are trained in the proper use of a computer

 

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

 

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

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

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

 

Cultivation starts from frozen animal cells

 

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

 

The finished drug product is formulated

The recombinant DNA construct is transformed into E. coli