II. 2 Quality risk management as part of

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II. 2 Quality risk management as part of
Industry

• Regulatory operationsInspection and assessment
  activities

Competent Authorities
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II.2 QRM as Part of regulatory operations

• Inspection and assessment activities
• To assist with resource allocation including e.g.
• Inspection planning
• Inspection frequency
• Intensity of assessment and inspection
• (see "Auditing" section in Annex II.1)
• To evaluate the significance of e.g.
• Quality defects
• CAPA following a recall
• Inspectional findings

ICH Q9
3
Scheduling Inspections

• Target Develop criteria, which can (easily) be
  evaluated/maintained by members of the
  department responsible for the audit plan.
• See previous section II.1 auditing / inspection

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II.2 QRM as Part of regulatory operations

• Inspection and assessment activities
• To determine the appropriateness and type of
  post-inspection regulatory follow-up
• To evaluate information submitted by industry
  including pharmaceutical development information
• To evaluate impact of proposed variations or
  changes
• To identify risks which should be communicated
• between inspectors and assessors
• To facilitate better understanding
• how risks can be or are controlled (e.g.,
  parametric release, Process Analytical Technology
  (PAT)

ICH Q9