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II. 2 Quality risk management as part of…

II. 2 Quality risk management as part of…. Regulatory operations Inspection and assessment activities. Industry. Competent Authorities. II.2: QRM as Part of regulatory operations. Inspection and assessment activities To assist with resource allocation including e.g .

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II. 2 Quality risk management as part of…

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  1. II. 2 Quality risk management as part of… Regulatory operationsInspection and assessment activities Industry Competent Authorities

  2. 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. EXAMPLE 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

  4. II.2: QRM as Part of regulatory operations Inspection and assessment activities • To determine the appropriateness and typeof 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

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