cGMP Part II – Equipment, validation, containers and closures, process/laboratory controls, Labels Flashcards
For the control of components, containers, closures, packages, and labels, a drug manufacturer’s quality control group should be procedures on the r ________, I __________, s___________, h___________, of the materials.
A) Receipt, identification, safety and handling
B) Receipt, identification, shipping and handling
C) Reprocessing, identification, storage and handling
D) Receipt, identification, storage and handling
E) Receipt, insulation, storage and handling
D) Receipt, identification, storage and handling
What information would be found in an executed batch record but not in the master batch record?
A) Deviations from the original manufacturing instructions
B) Passing criteria for tests for quality attributes
C) Detailed manufacturing, processing, packing and holding instructions
D) Quantities of raw materials or components to be used
E) The production flow diagram
A) Deviations from the original manufacturing instructions
What is a general requirement for prescription drug labeling?
A) The main intent of prescription drug labels is to guide the consumer on the safe use of the drug
B) Prescription drug labels should exclusively highlight the drug’s benefits while excluding any mention of adverse reactions.
C) Suggestion for use in another indication can be provided despite lack of evidence for efficacy in that indication
D) Prescription drug labels should not be promotional
E) Only benefits of the drug should be mentioned in prescription drug labels and adverse reactions omitted
D) Prescription drug labels should not be promotional
In the drug interaction section of drug labels, there could be a warning to avoid eating grapefruit when taking a drug. How does grapefruit affect the safe and effective use of a drug?
A) Grapefruit can lead to an increase in the amount of API in the target tissues
B) Eating grapefruit could not lead to a drug overdose
C) Labels never mention that eating grapefruit can affect drug safety
D) Grapefruit can lead to either an increase or decrease in the amount of API in the target tissues
E) Grapefruit can lead to a decrease in the amount of API in the target tissues
D) Grapefruit can lead to either an increase or decrease in the amount of API in the target tissues
_______________________ is an FDA-ran website that provides high quality information about marketed drugs and includes information found on drug package inserts.
A) Center for Disease Control
B) PubMed
C) DailyMed
D) NCBI
E) Structured Product Labels
C) DailyMed
What is the fair balance requirement?
A) A requirement that employees be allowed to have time off for their families to balance their work responsibilities
B) An advertising requirement which requires that the instructions for the proper use of the drug be clear and visible to consumers
C) A manufacturing requirement where the amount of drug product generated should be accounted for by the weights of the raw materials used in the process
D) A drug production stipulation ensuring that the income generated by a specific process will be at least equal to the expenses incurred.
E) An FDA advertising rule mandating that the negative effects and advantages of a medication be equally apparent to both consumers and physicians.
E) An FDA advertising rule mandating that the negative effects and advantages of a medication be equally apparent to both consumers and physicians.
Information in this drug manufacturing document is not covered by regulations on advertising and promotion.
A) Social media postings
B) Direct mailers to health professionals
C) Certificate of analysis
D) Drug launch materials
E) Patient testimonial videos
C) Certificate of analysis
What is not a violation of FDA’s regulations on drug promotion and advertising?
A) Advertising to an age group for which the drug is not FDA-approved for
B) Printing information on patient satisfaction which is not based on a well-designed study
C) Lack of statement suggesting efficacy for an indication in which the drug is not approved for
D) Ad lacks a statement encouraging the patient to report negative side effects to the Better Business Bureau.
E) Fair balance violation with prominent letters for benefits, but small font for the risks
D) Ad lacks a statement encouraging the patient to report negative side effects to the Better Business Bureau.
AND
C) Lack of statement suggesting efficacy for an indication in which the drug is not approved for
What property of containers and closures will not preserve the quality of drug products?
A) Containers and closures should be designed to facilitate the entry of moisture from the outside
B) Closures should not allow loss of drug substance to the outside
C) Containers and closures should not leach any chemical or absorb any of the drug components
D) Containers and closures should be minimally reactive with the drug product
E) Containers and closures should be clean and sterilized
A) Containers and closures should be designed to facilitate the entry of moisture from the outside
For the sampling of components, containers, and closures, there should be a written protocol that needs to be followed. What is not a requirement for the sampling procedures and tests?
A) FDA requires at least 1 test of conformity to specifications as to CC quality and identity
B) Samples should be taken at representative and random places in the beginning, middle and end for each material
C) During sampling, care must be taken to avoid contamination of the components, containers, and closures
D) The passing criteria for samples should be adjusted if samples keep failing to pass the criteria
E) Samples of CCCs must be labelled, dated, and personnel who did the sampling must sign
D) The passing criteria for samples should be adjusted if samples keep failing to pass the criteria
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?
A) Insufficient drying can lead to unacceptable moisture levels in tablets
B) Prolonged holding of a raw material can increase risks of microbial contamination
C) Insufficient mixing may lead to failed content uniformity in tablets
D) Prolonged drying can lead to degradation of an API
E) Prolonged process can lead to longer working hours
E) Prolonged process can lead to longer working hours
Which applies to cGMP regulations on packaging and label control?
A) Excess, unused labels should be stored on a low humidity shelves
B) Manufacturers are not expected to account for where all issued labels went
C) Excess labels should be destroyed and not returned to printing company
D) Labels for different drug products, should be organized neatly in one shelf
E) Expiration dates required on labels are based on when the drugs got FDA approval
C) Excess labels should be destroyed and not returned to printing company
Under CFR21, Subpart I on laboratory controls, what is not correct about cGMP requirements for release testing of drug products?
A) Sampling design should be statistically sound
B) Microbiological tests should be conducted if necessary for a particular drug product
C) Tests should be performed to determine conformance to specifications promptly after the release of each batch
D) Test methods should be accurate, sensitive, specific, and reproducible
E) Conformance testing should be performed by the quality control unit
C) Tests should be performed to determine conformance to specifications promptly after the release of each batch
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?
A) Specificity is the ability of a test method to give the same peaks, patterns of peaks, and amounts of the components as in the previous runs.
B) Sensitivity is the ability of a test method to give the same peaks, patterns of peaks, and amounts of the components as in the previous runs.
C) Reproducibility is the ability of a test method to give the same results when samples are performed by different analysts.
D) Accuracy 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
C) Reproducibility is the ability of a test method to give the same results when samples are performed by different analysts.
What is not true of cGMP regulations concerning laboratory records?
A) Data from failed test results should not be recorded in laboratory notebooks
B) Records should be retained and readily available at site where activities occurred, or available electronically
C) Laboratory records must be retained for at least 1 year after the batch expiration date.
D) Laboratory records must include methods used, weights and measures, graphs, charts, and calculations
E) The analyst who performed the experiments must sign and date the laboratory records
A) Data from failed test results should not be recorded in laboratory notebooks
