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