RAPS RAC-GS Online Practice Questions and Exam Preparation

RAPS RAC-GS Online Questions & Answers

• Question 91:

  According to the ICH guideline on GMP for API,to which of the following is the MOST stringent requirement applied?

  A. Physical processing and packaging
  B. Isolation and purification
  C. Production of Intermediate(s)
  D. Introduction of the API starting material
  A. Physical processing and packaging

• Question 92:

  According to ICH, what is the MAXIMUM amount of timein calendar days that anorganizationhas from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?

  A. 3
  B. 5
  C. 10
  D. 15
  B. 5
  C. 10
  D. 15

• Question 93:

  According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?

  A. 3
  B. 5
  C. 7
  D. 9
  C. 7

• Question 94:

  A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?

  A. The ISO national member body
  B. The ISO technical committee in charge of the area
  C. The ISO Secretariat
  D. The country's regulatory authority
  A. The ISO national member body
  D. The country's regulatory authority

• Question 95:

  Company X is planning to acquire the rights for a product marketed by Company Y. As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

  A. Intellectual properly
  B. Clinical trial data
  C. Safety issues
  D. Marketing materials
  C. Safety issues

• Question 96:

  Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?

  A. "Is the product profitable for the manufacturer?"
  B. "Is the product better than currently available alternatives?"
  C. "Has the product been approved for morand4nan 10 years?"
  D. "Is the product an established gold standard?"
  B. "Is the product better than currently available alternatives?"

• Question 97:

  A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product. To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?

  A. Label the product for use in appropriate populations.
  B. Educate patients and healthcare providers on how to use the product
  C. Delay product launch until required studies are completed.
  D. Promote off-label use to a carefully selected patient population.
  D. Promote off-label use to a carefully selected patient population.

• Question 98:

  Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?

  A. Active-controlled
  B. Cross-over
  C. Dose-ranging
  D. Placebo-controlled
  B. Cross-over

• Question 99:

  Which of the following claims would classify an apple as a drug?

  A. "It will make you look younger."
  B. "It will satisfy hunger."
  C. "It will whiten teeth."
  D. "It will prevent colds."
  D. "It will prevent colds."

• Question 100:

  Which of the following is MOST appropriate for the purpose of lot release of biologics?

  A. Inventory control
  B. Safety assurance
  C. Efficacy confirmation
  D. Quality verification
  D. Quality verification