Practice school -QA

What is pharmaceutical quality assurance?

• A. Ensuring drugs are safe and effective for human use
• B. Developing new drugs
• C. Promoting drugs to the public
• D. Implementing systems to ensure drugs meet regulatory requirements and are of good quality

Which of the following is not a principle of pharmaceutical quality assurance?

• A. Continuous improvement
• B. Risk assessment
• C. Regulatory compliance
• D. Cost reduction

What is the goal of pharmaceutical quality assurance?

• A. To maximize profits
• B. To minimize costs
• C. To ensure drugs are of good quality and meet regulatory requirements
• D. To promote the company's brand

What is the difference between quality control and quality assurance?

• A. Quality control focuses on preventing defects, while quality assurance focuses on detecting defects
• B. Quality control involves implementing systems to ensure drugs meet regulatory requirements, while quality assurance involves testing finished products
• C. Quality control only applies to large pharmaceutical companies, while quality assurance applies to all pharmaceutical companies
• D. Quality control is a legal requirement, while quality assurance is optional

Which of the following is an example of a risk assessment tool used in pharmaceutical quality assurance?

• A. Failure mode and effects analysis (FMEA)
• B. High-performance liquid chromatography (HPLC)
• C. Friability testing
• D. Fourier transform infrared spectroscopy (FTIR)

What is the purpose of document control in pharmaceutical quality assurance?

• A. To keep track of raw materials used in the manufacturing process
• B. To ensure finished products meet regulatory requirements
• C. To ensure documents related to pharmaceutical manufacturing are up-to-date and accurate
• D. To test the efficacy of the drug

What is the difference between a corrective action and a preventive action?

• A. Corrective actions are taken after a problem has occurred, while preventive actions are taken before a problem occurs
• B. Corrective actions are optional, while preventive actions are mandatory
• C. Corrective actions focus on preventing future problems, while preventive actions focus on fixing current problems
• D. Corrective actions only apply to large pharmaceutical companies, while preventive actions apply to all pharmaceutical companies

Which regulatory agency is responsible for overseeing pharmaceutical quality assurance in the United States?

• A. The Food and Drug Administration (FDA)
• B. The World Health Organization (WHO)
• C. The European Medicines Agency (EMA)
• D. The Centers for Disease Control and Prevention (CDC)

Which of the following is an example of a quality audit in pharmaceutical quality assurance?

• A. In-process testing
• B. Finished product testing
• C. Raw material testing
• D. Facility inspection