Pharmaceutical Product Contamination Quiz

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Questions and Answers

Why is the presence of microorganisms in pharmaceuticals a problem?

  • They improve the aesthetic appeal of the product
  • They enhance the active pharmaceutical ingredient
  • They decrease the need for product recall
  • They represent an infection hazard (correct)

What is the primary reason for controlling the microbial content of non-sterile pharmaceuticals?

  • To reduce the need for product recall
  • To protect from infection risk (correct)
  • To enhance the aesthetic appeal
  • To ensure chemical stability

What is the purpose of setting stringent limits for the presence of microorganisms in non-sterile pharmaceuticals?

  • To ensure low bioburden in finished dosage forms (correct)
  • To enhance the aesthetic appeal of the product
  • To increase the effectiveness of the active pharmaceutical ingredient
  • To reduce the need for hygienic manufacture

Who sets the limits for the presence of microorganisms in non-sterile pharmaceuticals in Europe?

<p>European Pharmacopoeia Commission (C)</p> Signup and view all the answers

What are the potential consequences of microbial contamination in pharmaceutical products?

<p>Product recall, adverse publicity, litigation (B)</p> Signup and view all the answers

Why is the presence of microorganisms in pharmaceuticals a problem?

<p>They may degrade the active pharmaceutical ingredient, making it inactive (B)</p> Signup and view all the answers

What is the primary reason for controlling the microbial content of non-sterile pharmaceuticals?

<p>To reduce the risk of infection and spoilage during use (B)</p> Signup and view all the answers

What may result from the presence of microorganisms in pharmaceutical products?

<p>Product recall and adverse publicity (A)</p> Signup and view all the answers

What is the purpose of setting stringent limits for the presence of microorganisms in non-sterile pharmaceuticals?

<p>To ensure a low bioburden of finished dosage forms (A)</p> Signup and view all the answers

What represents an infection hazard in pharmaceuticals?

<p>The presence of microorganisms (A)</p> Signup and view all the answers

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