Pharma Previous exam questions
Which of the following type of validation often leads to the transfer manufacturing process from development phase to production phase? A. Prospective B. Retrospective C. Concurrent D. Revalidation
A. Prospective
Process validation establishes scientific evidence that a process is capable of consistently delivering quality product. A. True B. False
A. True
Quality assurance helps prevent quality issues through process-oriented methods. A. True B. False
A. True
Shipping studies help us understand the effect of shipping on the package design. A. True B. False
A. True
Surface sampling includes all areas which the product comes in contact with. A. True B. False
A. True
Viable Monitoring quantifies the microbial load in the air. A. True B. False
A. True
The following department proves and documents that equipment or systems are properly installed and comply with the specified requirements: A. Validation B. Auditing C. Qualification D. Training E. Engineering
A. Validation
Which of the following is NOT an example of physical environmental monitoring? A Viable air sampling B. Pressure monitoring C. Air flow rate monitoring D. Humidity monitoring
A. Viable air sampling
Ideal growth medium, temperature, gas composition, and time are all needed to allow the growth of microbes on an agar plate. A. True B. False
A. true
Clean room contamination control is performed with the following (select all that apply): A Limiting the number of trained personnel occupying the space B. Filtering the volume of the air entering the clean room C.Regularly monitoring equipment
All the above
The following people can initiate a complaint that quality needs to address: A. Internal personnel B. External stakeholders C. Customers D. Hospitals E. Anyone
Anyone
Which of the following Codes of Federal Regulation outlines how pharmaceutical companies need to record data and keep rack of records? A. CFR 20 Part 11 B. CFR 21 Part 11 C. CFR 22 Part 11
B. CFR 21 Part 11
It is alright to use any date format when following GDP. True or False
B. False
Objectionable organisms do not cause illness but are still not allowed in the final product. A. True B. False
B. False
The outbreak of fungal meningitis in steroid injection produced by the New England Compounding Center led to the establishment of Kefauver-Harris Drug mendments. A. True B. False
B. False
We do not account for detectibilty in risk assessment as we are supposed to be able to detect anything we are looking for. True or False
B. False
Which of the following laminar flow hood provides filtered air that moves from behind the work area toward the operator? A. Vertical flow hood. B. Horizontal flow hood C. Class VI flow hood D. Class V flow hood
B. Horizontal Flow hood
The following utilizes historical data to provide evidence that a process performs as claimed. A, Prospective validation B. Retrospective validation C. Concurrent validation D. Revalidation
B. Retrospective validation
How many methods are there to syringe filling? A 4 B 3 C 2
C. 2
Which of the following type of drug application is submitted for the approval of a generic drug product? A. Investigational new drug Application B. New Drug Application C. Abbreviated New Drug Application D. Over the Counter Drugs Application. E. Biologic License Application
C. Abbreviated New Drug Application
Which of the following method uses WFI to sterilize the manufacturing equipment: A. SIP В. MBR C CIP D. BFS
C. CIP
Which of the following type of audits reviews actions of the manufacturer undertaken in response to a violation CGMP observed during a previous audit? A. Pre-Approval Audit B. Four-Cause Audit C. Compliance Audit D. Routine Audit
C. Compliance Audit
Which of the following aspect of quality management system is in place to ensure that only current documents are being used by all personnel? A. Training control B. CAPA management C. Document control D. Change management
C. Document control
Which of the following testing is performed to ensure the sterility of the product is met? A. Chemistry based testing B. Mechanical based testing C. Microbiology based testing D. Physical based testing
C. Microbiology based testing
The deviation must not affect the error is specified at the time the Which of the following is true about planned deviations? A. They are undocumented B. A deviation plan to correct the error is specified at the time the deviation occurs C. The deviation must not affect the final quality of the product D. An excursion must always follow the planned deviation
C. The deviation must not affect the final quality of the product
Which of the following is NOT an ingredient used for the formulation of drugs? A. API B. WFI C. Parison D. Excipients
C. parison
Which of the following is NOT included in the testing of functionality of the product's delivery system? A. Seal integrity B. Pressure E Visible particles D. Injectability
C. visible particles
The drug quality security act consists of the following titles A. DQSA B.ANDA C. CQA D. CQSA E. DSCSA
CQA and DCSA
Which of the following cleanroom classification allows for the least particles and CFUS? A. ISO 6 B. Class C C. ISO 9 D. Class A
Class A
Which of the following is NOT a type of environmental monitoring? A. Microbial B. Physical C. Personnel D. Chemical
D. Chemical
The following people can initiate a complaint that quality needs to address: A. Internal personel B. External stakeholders C. Customers D. Hospitals E. Anyone
E. Anyone
Environmental Monitoring is a direct measure of batch sterility. A. True B. False
False
Filling takes place in an ISO 6 environment. A. True B. False
False
Filter sterilization is only applicable to suspension formulation. A. True B. False
False
ISO 5 environments allow up to 10 CFUS. A. True B. False
False
If we have a label claim of 50 mL we fill the container with exactly and only 50 mL. A. True B. False
False
Process validation includes checking the product at one specified time and location within the production process. A. True B .False
False
The FDA never enforces product recalls. True or False
False
True or False: The FDA does not regulate medical devices
False
You do not need to provide names when you are running a 503A operation. A. True B. False
False
Standard Operation Practices are a set of standards that we follow and are required by regulations ? True or False
False (Keyword Practices needs to be procedures)
The following 3 attributes are analyzed during the study of risk of risk assessment: A Likelihood B. Variability C.Detectability D.Severity E. Origination
Likelihood detectibilty severity
According to GMP , documents can be superseded within the: A. Validation System B. Quality System C. Engineering department D. Production Department
Quality system
DSCSA is not in effect yet, but CQA is A True B. False
True
Filling takes place in a ISO 5 environment True of false
True
Shipping studies should consider both minimum and maximum load scenarios. True or False
True
The most common source of contamination is personnel. True B. False
True
The vent placement stopper technique allows for air to escape around a compressed stopper. A True B. False
True
Which of the following best describes parison? A. A specialized filling needle B. The tube formed from molten resin C. Homogenous solution that flows through a series of filters D. A 0.2 um hydrophilic membrane filter
Tube formed from molten resin
What does USP stands for? A. United States Pharmaceuticals United States Pharmacopeia C. United States Protocols D. None of the above
United States Pharmacopeia
The following resin additive is used for photosensitive resin: A. Colorants B. Plasticizers C. Optical brighteners D. UV stabilizers
Uv stabilizers
Out-of-specification results when the sample does not meet the accepted established criteria. A True B. False
true
What are the most common syringe container sizes in RTU (ready to use) formats ? A 1, 5, 10 and 50 mL B. 10 and 50 mL C. 20, 100 mL
A
Which of the following is involved in determining the standards used to coordinate CGMP and regulations? A Location of manufacture B. API supplier C. Location of intended use D. USP
A Location of manufacture and C. Location of intended use
Which of the following type of audit occurs after a manufacturer submits a new product to the FDA? A Pre-Approval Audit B. Four-Cause Audit C. Compliance Audit D. Routine Audit
A Pre-Approval Audit
Which of the following is not one of the manufactures for BFS equipment? A. Epson B. Rommelag C. Weiler D. brevetti Angela
A epson
What is SAF A. support air flow B. support air force C. support air frequency
A support air flow
What does DQSA stand for? A. Drug quality security act B Drug Qualification and security act C. Drug Quality Supply Act
A. Drug quality security act
How many methods exists for syringe filling? A. 4 В. 3 C 2
2
The following is the most commonly issued for a penalty by the FDA A. Fines B. warning letters C. 483 observations D. recalls E. audits
483 observations
