Process-based Risk Management

Process-based Risk Management

Risk-Assessment

  • Establishment of a risk analysis strategy
  • Risk analysis of GMP plants
  • Risk analysis of computer systems

QbD-Assessment 

  • Process development via the QbD approach that helps implementing ICH quality guidelines Q8 and Q9
  • Application of the QbD risk analysis as combination of probability
    and severity of the considered risk
  • Adaption to the relevant risk

Top-Down-Strategy

  • Analysis of existing process workflows
  • Establishment of a top-down risk management
  • Specification of problems

PQR – Product Quality Review

  • Refurbishment of existing data
  • Establishment of product quality review for easy process specifications verification
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