Quality Risk Management in Pharmaceutical Manufacturing

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Questions and Answers

What is the scope of quality control?

  • Exclusively focused on product packaging
  • Only concerned with manufacturing processes
  • Limited to laboratory operations
  • Involved in all decisions that may concern the quality of the product (correct)

In which areas should quality control be involved?

  • Exclusively in laboratory testing
  • In all decisions that may concern the quality of the product (correct)
  • Only in supply chain management
  • Only in production planning

What is the primary focus of quality control?

  • Manufacturing timelines
  • Product quality (correct)
  • Product pricing
  • Marketing strategies

What is the scope of quality control in terms of decision making?

<p>Involved in all decisions that may concern the quality of the product (B)</p> Signup and view all the answers

What aspect of quality control is emphasized?

<p>Involvement in all product-related decisions (C)</p> Signup and view all the answers

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Study Notes

Quality Risk Management

  • Pareneteral quality control involves four critical steps:
    • Daily testing of water for injection
    • Confirmation of fill, doses, and yields
    • Checking and approving intermediate production stages
    • Checking label identity and count

Importance of Quality Assurance

  • Quality assurance is crucial in manufacture and preparation processes
  • Methods and processes must be carefully established and validated
  • Strict adherence to established methods and processes is necessary

Extent of Quality Control

  • Quality control involvement is not limited to laboratory operations
  • Quality control must be involved in all decisions affecting product quality

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