1 / 4

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 .

coye
Download Presentation

II. 2 Quality risk management as part of…

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related