BTEC 3317 Quiz 11

What is not true of regulations concerning the control of components, containers, and closures?

Procedures on the receipt, identification, storage and handling of components, containers, and closures should be verbally communicated all the time

Components, containers, and closures are to be stored off the floor (in pallets) in the manufacturing site

Upon receipt, components, containers, and closures are quarantined prior to testing and release by the Quality control group

Upon receiving, components, containers, and closures are to be inspected for correctness of labels, contents, container damage or broken seals, and contamination.

Procedures on the receipt, identification, storage and handling of components, containers, and closures should be verbally communicated all the time

3 multiple choice options

What property of containers and closures will compromise the quality of drug products?

Containers and closures should be minimally reactive with the drug product

Containers and closures should not absorb any of the drug components

Container and closures should readily allow the loss of the drug material to the outside

Containers and closures should be free of endotoxins from gram-negative bacteria that will cause fevers when injected into a patient's bloodstream

Container and closures should readily allow the loss of the drug material to the outside

3 multiple choice options

When a raw material (or component) passes specifications, it is ready to be charged into and used in the manufacturing process. Usually a portion of the bulk material is transferred into a properly labelled container. What information is not to be found on the container label?

Weight of the component

Date of FDA approval

Product batch for which the raw material is being dispensed for

Signatures of who weighed the component and who cross-checked the information

Date of FDA approval

3 multiple choice options

For the sampling of components, containers, and closures, there should be a written protocol that needs to be followed. What is not compliant with cGMPs for the sampling procedures and tests?

There should be a pre-determined criteria for acceptance or rejection of the materials

Samples should be taken at representative and random places in the beginning, middle and end for each material

FDA requires at least 1 test of conformity to specifications as to CC quality and identity

During sampling, steps should be taken to expose components, containers, and closures to the air for long durations so they can get aerated

During sampling, steps should be taken to expose components, containers, and closures to the air for long durations so they can get aerated

3 multiple choice options

For a tablet drug dosage form, what would not be considered a critical quality attribute?

Disintegration time

Tablet to tablet uniformity of API amounts

Presence of floating fibers

Tablet to tablet weight variation

Presence of floating fibers

3 multiple choice options

What is meant by bioburden?

The microbial counts on a drug component or in-process materials

The microbial contamination on the personnel's skin

The burden on a biotech company's revenue as a result of aborted drug development

The level of health risks that a patient is exposed to when taking the drug

The microbial counts on a drug component or in-process materials

3 multiple choice options

Many production SOPs have time limitations on the performance of a process. What would not be a cGMP-related reason as to the need for time limitation?

Prolonged holding of a raw material can increase risks of microbial contamination

Insufficient drying can lead to unacceptable moisture levels in tablets

Prolonged process can lead to longer working hours

Insufficient mixing may lead to failed content uniformity in tablets

Prolonged process can lead to longer working hours

3 multiple choice options

Which is not true about cGMP regulations on packaging and label control?

Labels should be examined for conformity with information in batch production records

Labels for different drug products should be segregated

Excess labels issued should be returned to the company that printed them

Batch or lot numbers should be included in labels to facilitate tracking in case of customer complaints about the drug products or for recalls

Excess labels issued should be returned to the company that printed them

3 multiple choice options

The _____________________ on drug product labels is based on stability tests and can be affected by storage conditions, the most important of which are humidity and temperature.

Indication

Strength

Expiration date

Conditions for safe use

Expiration date

3 multiple choice options

Under CFR21, Subpart I on laboratory controls, what is not correct about cGMP requirements for release testing of drug products?

Release test methods should be accurate, sensitive, specific, and reproducible

Tests should be performed to determine conformance to specifications prior to the release of each batch

Microbiological tests should be performed for all types of drug products prior to release for marketing

Conformance testing should be performed by the quality control unit

Microbiological tests should be performed for all types of drug products prior to release for marketing

3 multiple choice options

cGMP regulations on laboratory controls require that the accuracy, sensitivity, specificity, and reproducibility of methods used to test raw and in-process materials and drug products, be established and documented. What is a correct description of the required parameters for cGMP-compliant test methods?

Reproducibility is the ability of a test method to give the same patterns of peaks and amounts of the components as in the earlier runs.

Sensitivity of a test method is it's ability to correctly quantify the amount of API in a given unit of a drug product or sample

Sensitivity of a test method would be best described as its ability to tell that a chemical one is interested in quantifying is what it's supposed to be and not a different chemical

Accuracy is the ability of a test method to produce the same results when samples are performed by different analysts.

Reproducibility is the ability of a test method to give the same patterns of peaks and amounts of the components as in the earlier runs.

3 multiple choice options

What is not true of cGMP regulations concerning laboratory records?

Laboratory records must include methods used, weights and measures, graphs, charts, and calculations

Laboratory records for prescription drugs must be retained for at least 3 years after the batch expiration.

The analyst who performed the experiments must sign and date the laboratory records

Laboratory records must include complete data, including non-conforming results, from all tests done to assure compliance

Laboratory records for prescription drugs must be retained for at least 3 years after the batch expiration.

3 multiple choice options

What information would be found in an executed batch record but not in the master batch record?

ID and signature of persons who performed steps in the manufacturing process

Passing criteria for tests for quality attributes

The production flow diagram

Detailed manufacturing, processing, packing and holding instructions

ID and signature of persons who performed steps in the manufacturing process

3 multiple choice options

What is not correct about off-label drug use (prescribing) or off-label advertising?

Off-label use is when a physician prescribes a drug for an indication for which its use has not yet been approved by the FDA

Off-label advertising is when a drug manufacturer, or its representative, promotes the use of an approved drug for an indication for which it is not FDA-approved for.

Off-label advertising is considered illegal and punishable by law

Off-label advertising is generally an acceptable practice

Off-label advertising is generally an acceptable practice

3 multiple choice options

What is not a violation of FDA's regulations on drug promotion and advertising?

Advertising material clearly suggests efficacy for an indication in which the drug is not approved for

Ad lacks a statement encouraging the patient to report negative side effects to the Better Business Bureau.

Printing information on patient satisfaction which is not based on a well-designed study

Fair balance violation with prominent letters for benefits, but small font for the risks

Ad lacks a statement encouraging the patient to report negative side effects to the Better Business Bureau.

3 multiple choice options