II. 2 Quality risk management as part of…
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Annex II: Potential Applications prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1 ICH Q9 QUALITY RISK MANAGEMENT II. 2 Quality risk management as part of… Regulatory operations Inspection and assessment activities Competent Authorities Industry
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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 . - PowerPoint PPT Presentation
Transcript of II. 2 Quality risk management as part of…
Annex II: Potential Applications
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1
ICH Q9 QUALITY RISK MANAGEMENT
II. 2 Quality risk management as part of…
Regulatory operations
Inspection and assessment activities
Competent Authorities
Industry
Annex II: Potential Applications
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 2
ICH Q9 QUALITY RISK MANAGEMENT
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
Annex II: Potential Applications
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 3
ICH Q9 QUALITY RISK MANAGEMENT
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
EXAMPLE
Scheduling Inspections
Annex II: Potential Applications
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 4
ICH Q9 QUALITY RISK MANAGEMENT
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
